pharmacogenetics
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.
Multigene PGx Testing Improves Outcomes for Schizophrenia Patients, Randomized Study Shows
A study comparing Chinese patients who received therapy guided by genetic testing and those who got standard care showed better outcomes for those in the PGx arm.
California Governor Signs Bill That Specifies PGx Testing is Covered Under Medi-Cal
AB 425 makes pharmacogenetic testing a covered benefit under the state healthcare coverage program for low-income residents starting July 1, 2024.
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.
Golden Helix Wins $400K SBIR Grant to Integrate Pharmacogenetics Analytics Into Genetic Testing
The company previously won a $1.8 million award from the National Institutes of Health to improve its detection algorithms for complex variants in sequencing data.