FDA Clears Two New Blood Tests to Detect Alzheimer’s in Adults

 https://alert.psychnews.org/fda-clears-two-new-blood-tests-to-detect-alzheimers-in-adults?utm_campaign=13476383-Psychiatric%20News%20Alert&utm_medium=email&_hsenc=p2ANqtz-9KV6FFBGYUj7ji1OLvOL1oqnBxYWLKLSXruAueEtxta0a7_B3-1lIybx-J2P3cCzQ22WCmCTTO__ysaXoH7EaNdikmOA&_hsmi=435433383&utm_content=435433383&utm_source=hs_email

• Cleared on August 24, Roche’s Elecsys Phospho-Tau Plasma (pTau217) blood test is billedas the first single biomarker, single assay, single cutoff test to both rule in or rule out Alzheimer’s in patients 55 and older in primary or secondary care settings. (Roche’s current tau test can only rule out a diagnosis.)
• The FDA’s clearance of pTau217 is supported by a large study involving 2,148 adults (ages 50 to 90) across four countries. The pTau217 test matched PET scan results conducted 12 months before or after the blood draw in 88% of cognitively impaired participants and 91% of unimpaired participants.
• On August 20, FDA cleared C2N Diagnostics’ PreclivityAD2 test, the first for use in adults as young as 40. PreclivityAD2 assesses the ratios of key beta amyloid and tau peptides associated with Alzheimer’s disease.
• PreclivityAD2’s clearance was supported by a study involving 1,142 adults with symptoms of cognitive decline. The test correctly ruled in 98% of those who had a positive result on a PET scan or CSF biomarker test and confirmed findings for 93% of those with a negative result.