Medicare contractor Novitas has been considering a limited local coverage determination for the test, which calculates PSA values and determines whether a patient may need a prostate biopsy.
The study reflects the importance of including multiple biomarkers for diagnostic and treatment decisions associated with pneumonia, IVD industry experts said.
While the laboratory industry hopes expanded price reporting will mitigate PAMA's impact, many labs, especially on the hospital side, may not be ready.
The company said it plans to move all its immunoassays to a single vendor, representing an opportunity worth between $250 million and $400 million annually.
Revenues of $1.96 billion for the third quarter were up from $1.89 billion in Q3 last year and beat the consensus Wall Street estimate of $1.94 billion.
The effort aims to help NJPCA centers improve their value-based care with a focus on patients with chronic conditions like diabetes and chronic kidney disease.
Companies in the AMR space have met resistance from investors and clinicians as a result of conflicting hospital priorities and perceived technology shortcomings.
ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.
The agency has proposed rolling back exemptions gained in a 2018 revision of the rule that labs say are key to maintaining access to molecular testing.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
