🤖 AI Summary
アルツハイマー病の初めての血液検査がFDAで承認されました。このテストは40歳以上の症状のある患者に適用でき、アミロイドとタウというタンパク質のバイオマーカーを一つの血液サンプルから測定します。 PrecivityAD2は、これらを迅速に評価する単一血液検査で、プラズマAB42/40とp-tau217/np-tau217を質量 espectrometry を使用して測定し、結果を陰性、おそらく陽性、またはAD陽性とスコアリングします。この検査は一か月前にFDA承認された最初のものであり、現在3つ目の承認を得ました。PrecivityAD2は1,142人の症状のある成人を対象にした臨床検証研究で97.6%の精度を示しました。また、慢性腎臓病や糖尿病などの共病状態を持つ患者でも結果が一致しました。この検査は一般的な健康Screeningには適しておらず、認知機能の衰えがある患者向けです。これは早期診断、臨床試験の強化、精密医療と組み合わせ治療の基礎を築くために重要なステップとなるでしょう。
The FDA has cleared the first Alzheimer's blood test for symptomatic patients as young as 40. The test measures amyloid and tau biomarkers from a single blood draw and identified positive biomarkers with 97.6% accuracy in a validation study. New Atlas reports: PrecivityAD2 is a single blood test that quickly assesses the proteins amyloid and tau, using mass spectrometry to measure plasma AB42/40 and p-tau217/np-tau217. The results are then scored, qualifying as negative, likely positive, or positive for AD. "Just over a year ago, there were no FDA-cleared blood tests for Alzheimer's, and now we have three," Isobel Coleman, chief executive officer of the Alzheimer's Drug Discovery Foundation (ADDF), said in a statement. "This is a proof point that sustained, early investment in translational science plays a catalytic role in moving promising ideas from the lab to patients."
In a recent clinical validation study, 1,142 symptomatic adults were tested using PrecivityAD2. The process accurately identified 97.6% of positive biomarkers. What's more, the results remained consistent even in patients with comorbidities like chronic kidney disease and diabetes, which can distort plasma amyloid samples. It's worth noting that the test isn't intended for general health screenings, but for patients who already show some cognitive decline. "As PrecivityAD2 and tools like it move further into clinical practice, they will enable earlier detection, sharpen clinical trials, and build the foundation for precision medicine and combination therapies," Coleman added.
Read more of this story at Slashdot.