Adam covers proteomics and the clinical lab market for GenomeWeb.
The agency has suggested approaches like third-party review would help manage the expected influx of submissions, but labs and vendors remain concerned.
The company is making its first major commercial push for its diabetic kidney disease test via a US licensing deal it inked this spring with Sonic Healthcare.
The agency has rebuffed calls to extend its public comment period, with the upcoming election and the next user fee cycle likely influencing its timeline.
Roughly a year after its launch, the company's Multiple Sclerosis Disease Activity (MSDA) test is being used by several dozen clinics around the country.
The company posted Q3 2023 revenues of $31.3 million, up from $26.6 million in Q3 2022 and beating the consensus Wall Street estimate of $27.6 million.
Following a recent leadership change, glycoproteomics firm InterVenn Biosciences is reevaluating its commercial strategy and direction.
The agency's initial failure to develop a COVID-19 test stemmed from factors ranging from inexperienced staff to a lack of quality safeguards and physical resources, OIG said.
The company also reported Q3 revenues of $3.06 billion, up from $2.87 billion in Q3 2022 and above the consensus Wall Street estimate of $2.99 billion.
With the calendar winding down and the House without a speaker, the PAMA reform bill could stall again this year, though another temporary fix may be in the offing.
The firm, which reported an 8 percent drop in Q3 total revenues but a 5 percent rise in base business revenues, is closely watching federal action on these two lab industry priorities.