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.
Multi-gene testing uncovers a pathogenic VHL variant in a 30-year-old woman with inconsistent personal and family cancer history putting her on an aggressive screening schedule.
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.
A gynecologist tested an unaffected patient for aberrations in many cancer risk genes and found a low-penetrance pathogenic RET variant despite the absence of medullary thyroid cancer in her family.
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.
Cancer centers in the CATCH-UP.2020 program found that community engagement, telemedicine, and trial navigators worked well in engaging minorities and rural communities.
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.
Jazz Pharmaceuticals' zanidatamab monotherapy and Seagen's Tukysa in combination with Herceptin showed promise in this subset of HER2-positive patients.
Researchers presented an exploratory analysis at ASCO that provided clues to why the major pathologic response rate in this Phase II study was lower than expected.