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
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.
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.
Decade After SCOTUS Gene Patents Ruling, Precision Medicine and Test Innovation Impact Under Debate
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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.

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.

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.

Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
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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."
