Adam Bonislawski

Bills in the House and Senate would establish Part B coverage for pharmacy testing for diseases like COVID-19, flu, respiratory syncytial virus, and strep throat.

The firm said the acquisition let it move into the "fast growing" MRD space and round out its offerings in cancer screening, pathology, and sequencing.

Industry figures have highlighted the untapped value in lab data, but translating that value into actual revenue requires overcoming a number of challenges.

The test showed good accuracy for detecting the disease while also distinguishing different subtypes, suggesting it could help guide treatment in the future.

Firms including Roche and Quest have moved into the space, providing both a vote of confidence and new competition for smaller players that pioneered it.

During its Q1 earnings call, the company said that hospitals that had paused lab system purchases during COVID-19 were reentering the market.

The ruling could impact patient access to preventive services like cancer screening, as well as laboratories and diagnostics companies that provide them.

A divided Congress and the retirement of one of the VALID Act's most prominent supporters in the Senate could make passing the bill a difficult lift.

A recent study suggests that the test, which measures the levels of eight autoantibodies in blood, could prove useful for early detection of the disease.

An agency official said FDA is in the process of advancing plans to regulate laboratory-developed tests through the notice-and-comment rulemaking process.