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.
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.
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."
If the Center for Genomic Interpretation's in silico quality assessment catches on with payors, some labs are sure to push back or propose data sharing as an alternative.
The payor wants to see data beyond what is required through CLIA, and recommends labs use the Center for Genomic Interpretation to gauge how well tests detect and interpret variants.
Several institutions, swayed by PGx experts and advocates, are setting up DPYD testing to avoid deadly chemo toxicities in patients even though the NCCN and FDA don't back it.
The company is offering combined germline and somatic cancer testing, and sharing patients' variants identified through that testing in a new research registry.
The Right Drug Dose Now Act seeks to address many of the barriers that have hindered integration of pharmacogenomic information into mainstream care.