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Potential Cancer Vaccine Entering Stage 3 Trials

Slashdot reader quonset writes: After decades of study and testing, a potential vaccine for cancer may be on the horizon. Dr. Thomas Wagner, founder of Orbis Health Solutions, is using the body's own immune system to fight the disease, with each shot personalized to the patient, according to ABC News. From the article: Typically, cancer cells evade a person's immune system because it is recognized as that person's cells. Wagner developed a tumor lysate particle only (TLPO) vaccine that uses a person's tumor cells to identify particular parts that are then presented back in the body using the vaccine in a way that can stimulate their immune system to gain the ability to detect these cancer cells like an infection, allowing the immune system to fight the cancer itself. "People used to ask me the question, 'When will there be a cure for cancer?' And I've been doing this for 60 years and I could never answer that question," Wagner said. "Until recently, until the last three or four or five years." Wagner believes this type of cancer treatment could be a key to finding the long-awaited cure for cancer, all cancers, if paired with early detection. Wagner's TLPO cancer vaccine has been tested in hundreds of patients with advanced forms of melanoma in Phase 2 clinical trials. The most recent data presented at an academic conference showed nearly 95% of people given only the vaccine were still alive three years after starting treatment and 64% were still disease-free. Among the most advanced forms of melanoma, disease-free survival after three years for people with stage III disease was 60% in the vaccine-only group, compared to about 39% in the placebo group. Disease-free survival for those with stage IV disease was about 68% in the vaccine-only group, and zero in the placebo group. The most common side effects were redness or pain at the injection site, fever and fatigue after the injection – similar to other vaccines that stimulate an immune response. Based on this data and other studies, the U.S. Food and Drug Administration has greenlit Wagner's vaccine to start a Phase 3 clinical trial. It will be a three-year endeavor with a goal to enroll 500 people and is planned to launch sometime this year, Riley Polk, president of Orbis Health Solutions, told WLOS, an ABC News affiliate in Asheville, North Carolina. Polk's own father was told there were no treatment options left for his lung cancer, according to the article. That was more than 10 years ago, and "His father opted to try Wagner's cancer vaccine and lived 10 more years before dying from something unrelated to cancer." Polk gives ABC News this quote. "You can tell me a lot of things, but you can't tell me [the vaccine] doesn't work."

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Cancer Researchers Show CRISPR-Edited CAR T Cells Could Improve Immunotherapy

There's already a powerful immunotherapy that "involves engineering a patient's T cells so they recognize and attack cancer cells," writes one of America's top cancer hospitals. The Memorial Sloan Kettering Cancer Center notes that CAR T cell therapy has already begun to revolutionize cancer treatment," with these "chimeric" T cells "multiplied in a lab and given back to the patient to be a continual fighting force against the cancer." But now "New research from the lab of physician-scientist Michel Sadelain, MD, PhD, shows that disrupting a single gene in the CAR T cells can make them more potent and able to fight tumors longer." In a paper published in Cancer Discovery, the team demonstrated that disrupting the gene SUV39H1 causes a ripple effect: It restores the expression of multiple genes that help sustain the T cells' longevity. The researchers showed that this approach improved CAR T cell effectiveness against multiple cancers in mice... The researchers used the gene-editing tool CRISPR/Cas9 to alter SUV39H1 in human CAR T cells. They placed these modified CAR T cells into mice that had been implanted with either human leukemia cells or prostate cancer cells. For both cancers, the CAR T cells were able to sustain their function without becoming exhausted, leading to tumor elimination. By contrast, mice with unedited CAR T cells did not survive the cancer. "The edited CAR T cells can maintain their anti-cancer effects, even when we challenged them repeatedly by exposing them to new tumors over time," Dr. Zhao says. "These results suggest that SUV39H1-edited CAR T cells may reduce tumor relapse in patients." There did not appear to be serious side effects in the mice, although researchers will need to confirm the safety of this approach in humans. The biotechnology company Mnemo Therapeutics is exploring the possibility of conducting clinical trials based on this research.

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FSF Warns About the Perils of Medical Devices with Un-Free Software

"Software that controls your body should always respect your freedom," warns the program manager of the Free Software Foundation: In July, users of the proprietary software app LibreLink, who live in the UK and use Apple devices, found that the app they depend on to monitor their blood sugar was not working anymore after the developer Abbott pushed an update for the app... Despite what its name may suggest, there is nothing libre about the LibreLink app. It's proprietary software, which means users must depend on the company to keep it running and to distribute it. With free software, [a user] would have had the freedom to run, copy, distribute, study, change, and improve the software himself, or he could have leaned on a community of developers and users to share and fix the software, and the old version of the software would have been available to revert the update... Two months later, with Apple's update to iOS 17, users of the FreeStyle LibreLink and Libre 2 apps had reason again to fear that the software they rely on wouldn't work after updating their iPhones. This time, users all over the world were affected. In September, Abbott warned Apple users: "As part of the upcoming iOS 17 release, Apple is introducing StandBy Mode and Assistive Access Mode ... this release may impact your experience with the FreeStyle Libre 2 app, the FreeStyle LibreLink app, or the FreeStyle LibreLinkUp app. We recommend that you disable automatic operating system updates on the smartphone using the mentioned apps." This warning was made because StandBy Mode would sometimes prohibit time-sensitive notifications such as glucose alarms, and the Assistive Access Mode would impact sensor activation and alarm setting modification in the app... And a scenario where a company abandons service or updates to its users is not merely theoretical. This is the bitter reality faced by users of eye implants produced by Second Sight Medical Products since the company decided to abandon the technology in 2020 when facing the prospect of bankruptcy. [">According to IEEE Spectrum], Terry Byland, whose sight has been dependent on the first-generation Argus implant since 2004, says of his experience, "As long as nothing goes wrong, I'm fine. But if something does go wrong with it, well, I'm screwed. Because there's no way of getting it fixed." That's what also happened to Barbara Campbell, whose retinal implant suddenly stopped working when she was on a subway... It's up to us advocates of free software to inform the people around us of the issues with proprietary software in medical aids. Let's encourage our friends, parents, and grandparents to ask their doctor about the software in their medical devices and to choose and insist upon free software over proprietary software.

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Drugmakers Are Set To Pay 23andMe Millions To Access Consumer DNA

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著者: BeauHD
An anonymous reader quotes a report from Bloomberg: GSK will pay 23andMe $20 million for access to the genetic-testing company's vast trove of consumer DNA data, extending a five-year collaboration that's allowed the drugmaker to mine genetic data as it researches new medications. Under the new agreement, 23andMe will provide GSK with one year of access to anonymized DNA data from the approximately 80% of gene-testing customers who have agreed to share their information for research, 23andMe said in a statement Monday. The genetic-testing company will also provide data-analysis services to GSK. 23andMe is best known for its DNA-testing kits that give customers ancestry and health information. But the DNA it collects is also valuable, including for scientific research. With information from more than 14 million customers, the only data sets that rival the size of the 23andMe library belong to Ancestry.com and the Chinese government. The idea for drugmakers is to comb the data for hints about genetic pathways that might be at the root of disease, which could significantly speed up the long, slow process of drug development. GSK and 23andMe have already taken one potential medication to clinical trials: a cancer drug that works to block CD96, a protein that helps modulate the body's immune responses. It entered that testing phase in four years, compared to an industry average of about seven years. Overall, the partnership between GSK and 23andMe has produced more than 50 new drug targets, according to the statement. The new agreement changes some components of the collaboration. Any discoveries GSK makes with the 23andMe data will now be solely owned by the British pharmaceutical giant, while the genetic-testing company will be eligible for royalties on some projects. In the past, the two companies pursued new drug targets jointly. GSK's new deal with 23andMe is also non-exclusive, leaving the genetic-testing company free to license its database to other drugmakers.

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Can Humans Have Babies In Space? SpaceBorn United Wants To Find Out

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著者: BeauHD
An anonymous reader quotes a report from MIT Technology Review: Egbert Edelbroek was acting as a sperm donor when he first wondered whether it's possible to have babies in space. Curious about the various ways that donated sperm can be used, Edelbroek, a Dutch entrepreneur, began to speculate on whether in vitro fertilization technology was possible beyond Earth -- or could even be improved by the conditions found there. Could the weightlessness of space be better than a flat laboratory petri dish? Now Edelbroek is CEO of SpaceBorn United, a biotech startup seeking to pioneer the study of human reproduction away from Earth. Next year, he plans to send a mini lab on a rocket into low Earth orbit, where in vitro fertilization, or IVF, will take place. If it succeeds, Edelbroek hopes his work could pave the way for future space settlements. "Humanity needs a backup plan," he says. "If you want to be a sustainable species, you want to be a multiplanetary species." Beyond future space colonies, there is also a more pressing need to understand the effects of space on the human reproductive system. No one has ever become pregnant in space -- yet. But with the rise of space tourism, it's likely that it will eventually happen one day. Edelbroek thinks we should be prepared. Despite the burgeoning interest in deep space exploration and settlement, prompted in part by billionaires such as Elon Musk and Jeff Bezos, we still know very little about what happens to our reproductive biology when we're in orbit. A report released in September by the US National Academies of Science, Engineering, and Medicine points out that almost no research has been done on human reproduction in space, adding that our understanding of how space affects reproduction is "vital to long-term space exploration, but largely unexplored to date." Some studies on animals have suggested that the various stages of reproduction -- from mating and fertilization to embryo development, implantation, pregnancy, and birth -- can function normally in space. For example, in the very first such experiment, eight Japanese medaka fish developed from egg to hatchling aboard the space shuttle Columbia in 1994. All eight survived the return to Earth and seemed to behave normally.Yet other studies have found evidence that points to potential problems. Pregnant rats that spent much of their third trimester -- a total of five days -- on a Soviet satellite in 1983 experienced complications during labor and delivery. Like all astronauts returning to Earth, the rats were exhausted and weak. Their deliveries lasted longer than usual, likely because of atrophied uterine muscles. All the pups in one of the litters died during delivery, the result of an obstruction thought to be due in part to the mother's weakened state. To Edelbroek, these inconclusive results point to a need to systematically isolate each step in the reproductive process in order to better understand how it is affected by conditions like lower gravity and higher radiation exposure. The mini lab his company developed is designed to do exactly that. It is about the size of a shoebox and uses microfluidics to connect a chamber containing sperm to a chamber containing an egg. It can also rotate at different speeds to replicate the gravitational environment of Earth, the moon, or Mars. It is small enough to fit inside a capsule that can be housed on top of a rocket and launched into space.After the egg has been fertilized in the device, it splits into two cells, each of which divides again to form four cells and so on. After five to six days, the embryo reaches a stage known as a blastocyst, which looks like a hollow ball. At this point, the embryos in the mini lab will be cryogenically frozen for their return to Earth.

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USFWS Is Creating a Frozen Library of Biodiversity To Help Endangered Species

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著者: BeauHD
Kiley Price writes via Inside Climate News: In a new initiative announced on Tuesday, the U.S. Fish & Wildlife Service is working with the nonprofit Revive & Restore and other partners to create a "genetic library" of the country's endangered species -- before it's too late. Through a process called biobanking, FWS field staff are gathering biological samples such as blood, tissues and reproductive cells from animals to be cryogenically preserved at extremely low temperatures (at least -256 degrees Fahrenheit) and stored at a USDA facility in Colorado. The samples will also be genetically sequenced and this information will be uploaded to a publicly available database called GenBank, where researchers can study them and compare their genomes to other members of their species.

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A Biotech Company Says It Put Dopamine-Making Cells Into People's Brains

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著者: BeauHD
A biotech company has conducted a small-scale trial involving the implantation of lab-made neurons into the brains of 12 people with Parkinson's disease. The implanted neurons are designed to produce dopamine, which is deficient in Parkinson's patients, and early data suggests they may have survived and improved symptoms in some cases. MIT Technology Review reports: The study is one of the largest and most costly tests yet of embryonic-stem-cell technology, the controversial and much-hyped approach of using stem cells taken from IVF embryos to produce replacement tissue and body parts. The replacement neurons were manufactured using powerful stem cells originally sourced from a human embryo created an in vitro fertilization procedure. According to data presented by Henchliffe and others on August 28 at the International Congress for Parkinson's Disease and Movement Disorder in Copenhagen, there are also hints that the added cells had survived and were reducing patients' symptoms a year after the treatment. These clues that the transplants helped came from brain scans that showed an increase in dopamine cells in the patients' brains as well as a decrease in "off time," or the number of hours per day the volunteers felt they were incapacitated by their symptoms. However, outside experts expressed caution in interpreting the findings, saying they seemed to show inconsistent effects -- some of which might be due to the placebo effect, not the treatment. Because researchers can't see the cells directly once they are in a person's head, they instead track their presence by giving people a radioactive precursor to dopamine and then watching its uptake in their brains in a PET scanner. "It is encouraging that the trial has not led to any safety concerns and that there may be some benefits," says Roger Barker, who studies Parkinson's disease at the University of Cambridge. But Barker called the evidence the transplanted cells had survived "a bit disappointing." He said the results were not so strong, adding that it's "still a bit too early to know" whether the transplanted cells took hold and repaired the patients' brains.

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The 'Weird' Male Y Chromosome Has Finally Been Fully Sequenced

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著者: BeauHD
An anonymous reader quotes a report from The Conversation: The Y chromosome is a never-ending source of fascination (particularly to men) because it bears genes that determine maleness and make sperm. It's also small and seriously weird; it carries few genes and is full of junk DNA that makes it horrendous to sequence. However, new "long-read" sequencing techniques have finally provided a reliable sequence from one end of the Y to the other. The paper describing this Herculean effort has been published in Nature. The findings provide a solid base to explore how genes for sex and sperm work, how the Y chromosome evolved, and whether -- as predicted -- it will disappear in a few million years. [...] Spoiler alert -- the Y turns out to be just as weird as we expected from decades of gene mapping and the previous sequencing. A few new genes have been discovered, but these are extra copies of genes that were already known to exist in multiple copies. The border of the pseudoautosomal region (which is shared with the X) has been pushed a bit further toward the tip of the Y chromosome. We now know the structure of the centromere (a region of the chromosome that pulls copies apart when the cell divides), and have a complete readout of the complex mixture of repetitive sequences in the fluorescent end of the Y. But perhaps the most important outcome is how useful the findings will be for scientists all over the world. Some groups will now examine the details of Y genes. They will look for sequences that might control how SRY and the sperm genes are expressed, and to see whether genes that have X partners have retained the same functions or evolved new ones. Others will closely examine the repeated sequences to determine where and how they originated, and why they were amplified. Many groups will also analyze the Y chromosomes of men from different corners of the world to detect signs of degeneration, or recent evolution of function. It's a new era for the poor old Y.

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Scientists Genetically Engineer Bacteria To Detect Cancer Cells

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著者: BeauHD
An international team of scientists has developed a new technology that can help detect (or even treat) cancer in hard-to-reach places, such as the colon. The team has published a paper in Science for the technique dubbed CATCH, or cellular assay for targeted, CRISPR-discriminated horizontal gene transfer. Engadget reports: For their lab experiments, the scientists used a species of bacterium called Acinetobacter baylyi. This bacterium has the ability to naturally take up free-floating DNA from its surroundings and then integrate it into its own genome, allowing it to produce new protein for growth. What the scientists did was engineer A. baylyi bacteria so that they'd contain long sequences of DNA mirroring the DNA found in human cancer cells. These sequences serve as some sort of one-half of a zipper that locks on to captured cancer DNA. For their tests, the scientists focus on the mutated KRAS gene that's commonly found in colorectal tumors. If an A. baylyi bacterium finds a mutated DNA and integrates it into its genome, a linked antibiotic resistance gene also gets activated. That's what the team used to confirm the presence of cancer cells: After all, only bacteria with active antibiotic resistance could grow on culture plates filled with antibiotics. While the scientists were successfully able to detect tumor DNA in mice injected with colorectal cancer cells in the lab, the technology is still not ready to be used for actual diagnosis. The team said it's still working on the next steps, including improving the technique's efficiency and evaluating how it performs compared to other diagnostic tests. In the future, the technology could also be used for targeted biological therapy that can deploy treatment to specific parts of the body based on the presence of certain DNA sequences.

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Structure of Elusive Boron Monoxide Finally Determined After 83 Years

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著者: BeauHD
In an effort to discover new 2D materials, a team of scientists from Ames National Laboratory determined the structure of boron monoxide. Phys.Org reports: This compound was first discovered in the 1940s and maintained research interest throughout the years. Scientists were, however, unable to determine the structure of the material due to technological limitations of the time. Using new NMR methods and previously unavailable analytical tools, the team from Ames Lab finally solved the structure of this deceptively simple material. "We initially weren't really looking into studying this particular material," said Frederic Perras, a scientist from Ames Lab and member of the research team. "We were actually trying to make a carbon-free covalent organic framework." A covalent organic framework is a low-density and porous material with a periodically ordered crystal structure. It is composed of organic molecules that are linked together through covalent bonds. [...] Perras explained that boron monoxide is made using a precursor molecule that acts like building blocks. These molecules stick together through dehydration reactions. The key to understating the structure is to figure out how the blocks are physically arranged. "So we developed some NMR methods that allow us to study the orientation of these building blocks relative to each other. Basically, we found that adjacent precursor molecules were getting organized parallel to each other, which matched one of the previously proposed models," Perras said. "We also applied a lot of other techniques, including powder X-ray diffraction, which showed that these nanosheets organized themselves into what's called a turbostratic arrangement," said Perras. He explained that these stacked nanosheets are like a stack of paper thrown onto a desk. Once they land, they are not perfectly aligned, but they remain in a stack. The findings have been published in the journal American Chemical Society.

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Real-World 'Jurassic Park' Startup Argues Not De-Extincting Animals Would Be Even Scarier

George Church was part of the team that pioneered CRISPR gene editing. In 2021 he co-founded a kind of real-world "Jurassic Park" — Colossal Biosciences, a biotech startup working to de-extinct the Woolly Mammoth. For the 30th anniversary of the movie Jurassic Park, Rolling Stone brought in Colossal's co-founder and CEO, Ben Lamm, to share how the movie inspired and influenced their plans. Lamm writes that in 1993 he was 11 years old when he'd first seen the movie Jurassic Park. And even then, "Yes, as an 11-year-old I thought, what if dinosaurs could be real?" Lamm says he's now excited at "not just de-extincting animals but at the possibility for endless discoveries that would arise from the pursuit of doing so..." When I first told my lawyer that I was interested in starting Colossal and bringing back the woolly mammoth, he asked me if I had read Michael Crichton's book or seen Spielberg's Jurassic Park movie. Since then, it's a question that has come up in nearly every meeting with investors, journalists, and lawyers. I have, which meant that I spent a number of years thinking about if we should de-extinct animals before I set out to figure out if we could. (Thanks, Dr. Ian Malcolm.) Before ever setting foot in a lab, I spent many years and countless hours thinking about the moral questions at the heart of the story. And, with each successive year, I watched, heard, and learned about more and more animals dying due to climate change — a modern-day extinction. I came to the conclusion that the question is no longer should we practice de-extinction science but how long do we have to get it right... [T]he scary vision of the future isn't one where dinosaurs escape Isla Nubar and fly to the mainland, putting a healthy planet at risk, but instead a future where there aren't enough animals left to support food webs and ecosystems. And that includes humans, too... [I]t is our belief that it is possible to safeguard against or even stop that fatalist future vision using a similar approach in the original movie with some slight variations. It all goes back to genetics and a lot of what I learned about when I first met George... In the same way that wireless headsets, CAT scans, LEDs, the computer mouse, and thermal blankets are all products of going to the moon, de-extinction efforts have created breakthroughs already for both conservation and human healthcare. In Colossal's first few years of work, our woolly mammoth research alone has not only accelerated genetic rescue in elephants, but also, it is working to cure a deadly elephant virus that kills 25% of all baby elephants worldwide each year. The de-extinction toolkit is also establishing a genetic backup of all living elephant species, and building the necessary tools for elephant cloning and gestation. And now, unlike Dr. Hammond, who bought an island and hid his experiment from the world, governments are coming to us asking if we can help them to restore their critically endangered animals and help safeguard their keystone species. Lamm points out that you can get good DNA samples from specimens frozen in permafrost, skeletons preserved in caves, and from preserved specimens in museums. But "You can't get DNA from amber. Trust us. It's porous and doesn't preserve well."

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3M Reaches $10.3 Billion Settlement Over Contamination of Water Systems

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著者: BeauHD
3M will pay $10.3 billion to settle lawsuits over contamination of drinking water with PFAS, a class of chemicals known as "forever chemicals" that have been linked to health problems. NPR reports: The deal would compensate water providers for pollution with per- and polyfluorinated substances, known collectively as PFAS -- a broad class of chemicals used in nonstick, water- and grease-resistant products such as clothing and cookware. Described as "forever chemicals" because they don't degrade naturally in the environment, PFAS have been linked to a variety of health problems, including liver and immune-system damage and some cancers. The compounds have been detected at varying levels in drinking water around the nation. The Environmental Protection Agency in March proposed strict limits on two common types, PFOA and PFOS, and said it wanted to regulate four others. Water providers would be responsible for monitoring their systems for the chemicals. The agreement would settle a case that was scheduled for trial earlier this month involving a claim by Stuart, Florida, one of about 300 communities that have filed similar suits against companies that produced firefighting foam or the PFAS it contained. 3M chairman Mike Roman said the deal was "an important step forward" that builds on the company's decision in 2020 to phase out PFOA and PFOS and its investments in "state-of-the-art water filtration technology in our chemical manufacturing operations." The company, based in St. Paul, Minnesota, will halt all PFAS production by the end of 2025, he said. The settlement will be paid over 13 years and could reach as high as $12.5 billion, depending on how many public water systems detect PFAS during testing that EPA has required in the next three years, said Dallas-based attorney Scott Summy, one of the lead attorneys for those suing 3M and other manufacturers. The payment will help cover costs of filtering PFAS from systems where it's been detected and testing others, he said.

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US Approves Chicken Made From Cultivated Cells, the Nation's First 'Lab-Grown' Meat

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著者: BeauHD
An anonymous reader quotes a report from The Associated Press: For the first time, U.S. regulators on Wednesday approved the sale of chicken made from animal cells, allowing two California companies to offer "lab-grown" meat to the nation's restaurant tables and eventually, supermarket shelves. The Agriculture Department gave the green light to Upside Foods and Good Meat, firms that had been racing to be the first in the U.S. to sell meat that doesn't come from slaughtered animals -- what's now being referred to as "cell-cultivated" or "cultured" meat as it emerges from the laboratory and arrives on dinner plates. The companies received approvals for federal inspections required to sell meat and poultry in the U.S. The action came months after the U.S. Food and Drug Administration deemed that products from both companies are safe to eat. A manufacturing company called Joinn Biologics, which works with Good Meat, was also cleared to make the products. Cultivated meat is grown in steel tanks, using cells that come from a living animal, a fertilized egg or a special bank of stored cells. In Upside's case, it comes out in large sheets that are then formed into shapes like chicken cutlets and sausages. Good Meat, which already sells cultivated meat in Singapore, the first country to allow it, turns masses of chicken cells into cutlets, nuggets, shredded meat and satays. But don't look for this novel meat in U.S. grocery stores anytime soon. Cultivated chicken is much more expensive than meat from whole, farmed birds and cannot yet be produced on the scale of traditional meat, said Ricardo San Martin, director of the Alt:Meat Lab at University of California Berkeley. The companies plan to serve the new food first in exclusive restaurants: Upside has partnered with a San Francisco restaurant called Bar Crenn, while Good Meat dishes will be served at a Washington, D.C., restaurant run by chef and owner Jose Andres.

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Health Firm 'Grail' Wrongly Told Hundreds of People They Might Have Cancer

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著者: BeauHD
An anonymous reader quotes a report from CBS News: A biotechnology company selling a $949 blood test that it bills as a "first of its kind" to detect cancer said it incorrectly informed about 400 customers that they might have the disease. The Menlo Park, California, company, called Grail, said it sent a form letter to some customers who had bought its Galleri test, which detects a marker for more than 50 types of cancer, "stating incorrectly that a cancer signal was detected," a company spokeswoman told CBS MoneyWatch in a statement. The company blamed a vendor, PWN Health, for the error, citing a "software configuration issue." In a statement, PWN Health said it said the problem was due to "a misconfiguration of our patient engagement platform used to send templated communications to individuals." It added that it has added processes to make sure such a mistake doesn't occur again, and started contacting the people who received the erroneous letters within 36 hours. The error comes amid an increased demand for health care screening tests, especially for chronic diseases such as cancer. Grail is billing its service as a complement to routine single-cancer tests for diseases such as colon or breast cancer, and said that the blood test can detect forms of the disease that aren't routinely screened for, such as in the gallbladder and pancreas. Grail said it hasn't received reports of patient harm or "adverse events" due to the erroneous letters. "After being notified of the incident, Grail immediately began outreach by phone or email to all individuals who received the PWNHealth letter, and we continued our efforts until we confirmed we successfully reached each individual via phone, email or letter," the spokeswoman said. "The issue was in no way related to or caused by an incorrect Galleri laboratory test result." More than half the erroneous letters were sent to customers who hadn't had their blood drawn yet for the Galleri test, the spokeswoman added. On Monday, Illumina filed an appeal against a FTC order, "demanding that it divest cancer diagnostic test maker Grail over competition concerns in the U.S. market for cancer tests," reports Reuters. According to the filing, Illumina is arguing that the FTC "violated due process by depriving Illumina and Grail of a fair proceeding before an impartial tribunal."

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Theranos CEO Elizabeth Holmes Begins 11-Year Prison Sentence

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著者: BeauHD
Disgraced Theranos founder Elizabeth Holmes has begun her 11-year prison sentence after being convicted of four counts of fraud. The BBC reports: She will serve her term in a minimum-security prison in Texas. Holmes reported to the federal facility in Bryan, Texas, which holds between 500 and 700 inmates at any given time, on Tuesday. It is about 100 miles (160km) north of Houston, her hometown. Her arrival at the facility was confirmed by the Federal Bureau of Prisons, which declined to give any more details about her confinement, citing privacy concerns. There, the woman once billed as the world's youngest self-made billionaire might work alongside other inmates for between 12 cents (10p) and $1.15 (93p) an hour - much of which will go towards her court-mandated restitution payments. [...] The Texas prison camp where Holmes will serve time is a sprawling 37-acre facility. Most inmates there have been convicted of non-violent crimes, low-level drug dealing or white-collar offenses. According to the facility's handbook, life largely revolves around work and extracurricular activities that include foreign language, computer literacy or business courses. Holmes had fought to stay out of prison while her legal appeal works its way through the courts. She argued a delay would allow her to raise "substantial questions" about the case that could warrant a new trial. Her defense team also argued that she should remain free to care for her children, one who is nearly two and the other three months old. The Wall Street Journal reported the prison has facilities where inmates can host gatherings and where children can play. Holmes and other mothers are allowed to hold their children in their lap and breastfeed their infants, according to official Bureau of Prison guidelines.

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The First IVF Babies Conceived By a Robot Have Been Born

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著者: BeauHD
An anonymous reader quotes a report from MIT Technology Review: Last spring, engineers in Barcelona packed up the sperm-injecting robot they'd designed and sent it by DHL to New York City. They followed it to a clinic there, called New Hope Fertility Center, where they put the instrument back together, assembling a microscope, a mechanized needle, a tiny petri dish, and a laptop. Then one of the engineers, with no real experience in fertility medicine, used a Sony PlayStation 5 controller to position a robotic needle. Eyeing a human egg through a camera, it then moved forward on its own, penetrating the egg and dropping off a single sperm cell. Altogether, the robot was used to fertilize more than a dozen eggs. The result of the procedures, say the researchers, were healthy embryos—and now two baby girls, who they claim are the first people born after fertilization by a "robot." The startup company that developed the robot, Overture Life, says its device is an initial step toward automating in vitro fertilization, or IVF, and potentially making the procedure less expensive and far more common than it is today. Right now, IVF labs are multimillion-dollar affairs staffed by trained embryologists who earn upwards of $125,000 a year to delicately handle sperm and eggs using ultra-thin hollow needles under a microscope. But some startups say the entire process could be carried out automatically, or nearly so. Overture, for instance, has filed a patent application describing a "biochip" for an IVF lab in miniature, complete with hidden reservoirs containing growth fluids, and tiny channels for sperm to wiggle through. "Think of a box where sperm and eggs go in, and an embryo comes out five days later," says Santiago Munne, the prize-winning geneticist who is chief innovation officer at the Spanish company. He believes that if IVF could be carried out inside a desktop instrument, patients might never need to visit a specialized clinic, where a single attempt at getting pregnant can cost $20,000 in the US. Instead, he says, a patient's eggs might be fed directly into an automated fertility system at a gynecologist's office. "It has to be cheaper. And if any doctor could do it, it would be," says Munne.

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Synthetic Embryos Have Been Implanted Into Monkey Wombs

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著者: BeauHD
An anonymous reader quotes a report from MIT Technology Review: Embryos made from stem cells -- instead of a sperm and egg -- have been created from monkey cells for the first time. When researchers put these "synthetic embryos" into the uteruses of adult monkeys, some showed the initial signs of pregnancy. It's the furthest scientists have ever been able to take lab-grown embryos in primates -- and the work hints that it may one day be possible to generate fetuses this way. The team behind the research, Zhen Liu at the Chinese Academy of Sciences in Shanghai and his colleagues, started with embryonic stem cells originally taken from macaque monkey embryos. These cells have been grown in labs for multiple generations and, given the right conditions, have the potential to develop into pretty much any type of body cell, including those that make up organs, blood, and nervous system. The team used a set of lab conditions, which they tweaked and improved, to encourage embryonic stem cells to develop further. Over several days, the cells began developing in a very similar way to embryos. The resulting blobs of cells are called blastoids, because they look like early embryos, which are called blastocysts. After the blastoids had been growing in a dish for seven days, the researchers put them through a series of tests to figure out how similar they were to typical embryos. In one test, the team separated the individual cells in the blastoids and checked to see which genes were expressed in each one. The team analyzed over 6,000 individual cells this way. These tests revealed close similarities between the stem-cell-derived embryos and conventional monkey embryos. Some of the blastoids were grown for longer -- up to 17 days. These structures looked very much like typical embryos, the researchers say, although other scientists not involved in the study say more evidence is needed to prove just how similar they are. The only way to find out how embryo-like these blastoids really are is to test whether they can develop in a monkey's uterus. So the team put between eight and 10 seven-day-old blastoids into the uteruses of each of eight adult monkeys. The researchers then monitored the transferred blastoids for three weeks. The researchers believe that in three of these monkeys, the blastoids successfully implanted in the uterus and appeared to generate a yolk sac -- one of the very first signs of pregnancy. These monkeys also had elevated levels of pregnancy hormones. In other words, they would have had a positive pregnancy test. But within 20 days of transfer, the monkey blastoids stopped developing and seemed to come apart, say Liu and colleagues, who published their results in the journal Cell Stem Cell. The results suggest that blastoids still aren't perfect replicas of normal embryos. "That might be because a typical embryo is generated from an egg, which is then fertilized by sperm," reports MIT Technology Review. "A blastoid made from stem cells might express genes in the same way as a normal embryo, but it may be missing something crucial that normally comes from an egg." "There's also a chance that the team might have seen more progress if the experiment had been done in more monkeys. After all, of the 484 blastoids that were developing at day seven, only five survived to day 17."

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Meatball From Long-Extinct Mammoth Created By Food Firm

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著者: BeauHD
An anonymous reader quotes a report from the Guardian: A mammoth meatball has been created by a cultivated meat company, resurrecting the flesh of the long-extinct animals. The project aims to demonstrate the potential of meat grown from cells, without the slaughter of animals, and to highlight the link between large-scale livestock production and the destruction of wildlife and the climate crisis. The mammoth meatball was produced by Vow, an Australian company, which is taking a different approach to cultured meat. There are scores of companies working on replacements for conventional meat, such as chicken, pork and beef. But Vow is aiming to mix and match cells from unconventional species to create new kinds of meat. The company has already investigated the potential of more than 50 species, including alpaca, buffalo, crocodile, kangaroo, peacocks and different types of fish. The first cultivated meat to be sold to diners will be Japanese quail, which the company expects will be in restaurants in Singapore this year. [...] Vow worked with Prof Ernst Wolvetang, at the Australian Institute for Bioengineering at the University of Queensland, to create the mammoth muscle protein. His team took the DNA sequence for mammoth myoglobin, a key muscle protein in giving meat its flavor, and filled in the few gaps using elephant DNA. This sequence was placed in myoblast stem cells from a sheep, which replicated to grow to the 20 billion cells subsequently used by the company to grow the mammoth meat. "It was ridiculously easy and fast," said Wolvetang. "We did this in a couple of weeks." Initially, the idea was to produce dodo meat, he said, but the DNA sequences needed do not exist. Tim Noakesmith, cofounder of Vow, said: "We chose the woolly mammoth because it's a symbol of diversity loss and a symbol of climate change." Bas Korsten at creative agency Wunderman Thompson added: "Our aim is to start a conversation about how we eat, and what the future alternatives can look and taste like. Cultured meat is meat, but not as we know it." No one has yet to taste the mammoth meatball, notes the report. "We haven't seen this protein for thousands of years," said Wolvetang. "So we have no idea how our immune system would react when we eat it. But if we did it again, we could certainly do it in a way that would make it more palatable to regulatory bodies."

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FDA Clears Lab-Grown Chicken As Safe To Eat

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著者: BeauHD
An anonymous reader quotes a report from CBS News: The Food and Drug Administration on Monday cleared cultured "cultured chicken cell material" made by GOOD Meat as safe for use as human food. While the FDA said the lab-grown chicken was safe to eat, GOOD Meat still needs approval from the Agriculture Department before i can sell the product in the U.S. If approved, acclaimed chef Jose Andres plans to serve GOOD Meat's chicken to customers at his Washington, D.C. restaurant. He's on GOOD Meat's board of directors. The FDA previously gave the green light to lab-grown chicken made by Upside Foods in November. Upside Foods and GOOD Meat both use cells from chickens to create the cultured chicken products. Once cells are extracted, GOOD Meat picks the cells most likely to produce healthy, sustainable and tasty meat, the company explained. The cells are immersed in nutrients inside a tank. They grow and divide, creating the cultured chicken, which can be harvested after four to six weeks. GOOD Meat's chicken is already sold in Singapore. "Today's news is more than just another regulatory decision -- it's food system transformation in action," says Bruce Friedrich, president and founder of the Good Food Institute, a non-profit think tank that focuses on alternatives to traditional meat production. "Consumers and future generations deserve the foods they love made more sustainably and in ways that benefit the public good -- ways that preserve our land and water, ways that protect our climate and global health," Friedrich says.

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Three-Parent Baby Technique Could Create Babies At Risk of Severe Disease

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著者: BeauHD
MIT Technology Review has revealed two cases in which babies conceived with the three-parent baby technique have shown what scientists call "reversion." "In both cases, the proportion of mitochondrial genes from the child's mother has increased over time, from less than 1% in both embyros to around 50% in one baby and 72% in another," they report. From the report: When the first baby born using a controversial procedure that meant he had three genetic parents was born back in 2016, it made headlines. The baby boy inherited most of his DNA from his mother and father, but he also had a tiny amount from a third person. The idea was to avoid having the baby inherit a fatal illness. His mother carried genes for a disease in her mitochondria. Swapping these with genes from a donor -- a third genetic parent -- could prevent the baby from developing it. The strategy seemed to work. Now clinics in other countries, including the UK, Greece, and Ukraine, are offering the same treatment. It was made legal in Australia last year. But it might not always be successful. [...] Fortunately, both babies were born to parents without genes for mitochondrial disease; they were using the technique to treat infertility. But the scientists behind the work believe that around one in five babies born using the three-parent technique could eventually inherit high levels of their mothers' mitochondrial genes. For babies born to people with disease-causing mutations, this could spell disaster -- leaving them with devastating and potentially fatal illness. The findings are making some clinics reconsider the use of the technology for mitochondrial diseases, at least until they understand why reversion is happening. "These mitochondrial diseases have devastating consequences," says Bjorn Heindryckx at Ghent University in Belgium, who has been exploring the treatment for years. "We should not continue with this." "It's dangerous to offer this procedure [for mitochondrial diseases]," says Pavlo Mazur, an embryologist based in Kyiv, Ukraine, who has seen one of these cases firsthand.

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