Turna Ray
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.

Articles Authored by Turna Ray
Genetic Testing Challenges in Oncology: VHL Variant in Atypical Patient Raises Management Questions
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.

PGx Labs Searching for New Result Reporting Options After Translational Software's Failed 510(k) Bid
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Alternative clinical decision support services are available, industry observers said, but it's not clear whether they, too, will be subject to FDA enforcement.

Translational Software Shutting Down PGx Decision Support Services After FDA Regulatory Defeat
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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.
Genetic Testing Challenges in Oncology: Broad Panel Assessment Reveals Unexpected RET Finding
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.
NCI Program Explores Best Practices for Enrolling Underserved Groups to Precision Oncology Trials
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Cancer centers in the CATCH-UP.2020 program found that community engagement, telemedicine, and trial navigators worked well in engaging minorities and rural communities.
Large Study of Early-Onset Colorectal Cancer Patients IDs Unique, Potentially Actionable Mutations
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.

AstraZeneca's Tagrisso Fails Primary Endpoint in Small Neoadjuvant NSCLC Study
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.
