Turna Ray has been covering the personalized medicine and molecular diagnostics industries for GenomeWeb since 2006. She closely tracks the evolving regulatory, reimbursement, and business environment for precision medicine products.
Laws passed in 14 states appear to require commercial payors to cover biomarker tests broadly that meet certain evidentiary criteria, but payors may have a different interpretation.
Alternative clinical decision support services are available, industry observers said, but it's not clear whether they, too, will be subject to FDA enforcement.
The firm was pursing 510(k) clearance for software that provides treatment recommendations based on PGx variants detected by lab customers, but the FDA issued a negative decision.
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.
While some say that striking down gene patents opened up the genetic testing market and patient access, others see greater uncertainty about patent rights and reduced investment.
In younger patients, HER2 mutations were more prevalent in those who had MSI-high/TMB-high tumors, while POLE mutations were more common in MSS/TMB-high tumors, researchers reported at ASCO.
Members of the National Society of Genetic Counselors are frustrated with the lack of reproductive rights advocacy and progress on a Medicare payment bill and want new political leadership.
After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.
During the third quarter, the company saw 24 percent revenue growth from the year-ago period, but the company lowered its full-year expectations.
The company, infamous and long derided in the genetic testing community for refusing to share BRCA1/2 variants, has decided to change its stance as part of a "strategic transformation."