Biomarker Tests & Related Drugs

Newly Approved Drugs for Degenerative Brain Diseases

Amyloid Tests

Here are links to some of the newly approved amyloid tests

Blood Tests

Precivity C2N

Roche

Quest **direct to consumer is controversial

CSF Tests

Fujirebio Lumipulse

Roche: Elecsys pTau181/Abeta42tTau/Abeta42


News on Lab Developed Tests

FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests (LDT)

"The proposed rule seeks to amend the FDA's regulations to make explicit that in vitro diagnostics (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the agency intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs. The FDA would phase out its general enforcement discretion approach for most LDTs. The proposed phaseout is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while avoiding undue disruption to the testing market. After this phaseout, the FDA generally would expect IVD makers to meet the same applicable requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged."