Adam Bonislawski

The field's rapid advances make securing reimbursement an important area of focus, researchers in a recent commentary argued.

The company is targeting its RPPA-based testing to biopharma firms as well as for clinical trial work and to clinicians to help guide therapy in cancer patients.

The letter encourages drug developers to "further study and use" αSyn-SAA testing for selecting patients for clinical trials for Parkinson's and related diseases.

The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.

The company looks to tackle the Alzheimer's market by supplying global diagnostics firms with the antibodies needed for their tests in the space.

Observers suggested that recent and ongoing shifts in the legal landscape may put the FDA in a less advantageous position than it might have enjoyed in the past.

The rule makes explicit that LDTs are subject to FDA oversight but provides for enforcement discretion across a broad range of tests.

Two studies, led by researchers at Oxford and University College London, aim to explore whether blood-based markers can speed up diagnoses and improve outcomes.

The company recently published a study in JAMA on the test and is in the middle of two additional clinical trials as it closes a $6 million Series A funding round.

Many firms in the space have developed or are developing tests for the marker, which shows great promise for detecting brain amyloid pathology.