Adam Bonislawski

Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.

While Congress has protected labs from PAMA cuts via a series of one-year delays, this has locked lab prices at 2016 levels, heightening the urgency for a permanent fix.

The company expects its five-marker LucentAD Complete test to offer higher performance than single-marker assay and to secure higher reimbursement.

CEO Jim Davis said the company is on track to close eight lab acquisition deals this year, though he added that it is now in an "integration and digestion" phase.

Retirements and the outcomes of a handful of close races could reshape congressional committees tasked with oversight of issues important to labs.

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 company aims to streamline its own lab operations while also enabling distribution of its Alzheimer's tests to outside labs both in the US and abroad.

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 drop represents a return to a more normal pace of openings post-pandemic but likely also reflects the reimbursement and regulatory challenges facing the industry.