FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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Ron Shinkman
Ron Shinkman is a veteran journalist and editor with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare and also wrote for the Los Angeles and Orange County Business Journals.
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Dx Deals: Veracyte Acquires Convergent Genomics for up to $180 Million
The deal gives the oncology-focused Veracyte a boost in bladder cancer detection
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Diagnostics Pipeline: Quest Diagnostics Offers New Test for Estimating Biological Age
Developed by a British firm, the test will be available as a $29 add-on to pricier genetic profiling assays
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Dx Deals: Profusa Trying to Buy G3 Vision Labs in Unusual $455 Million Stock Deal
If Profusa pulls off the purchase, it will give the startup its first revenue source
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FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
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Diagnostics Pipeline: Cizzle Bio Introduces Test for Earlier Lung Cancer Detection
The CIZ1B biomarker blood-based assay has 95% sensitivity for detecting earliest stage of the cancer
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FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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Dx Deals: Danaher Acquires StatLab in Deal Valued at More than $1 Billion
The company will fold into Leica Biosystems after the transaction closes at the end of this year
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Diagnostics Pipeline: Xella Health Launches Platform Focused on Women’s Medical Issues
The startup is trying to close the care gap between female and male patients
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Dx Deals: Labcorp Quietly Buys Tribal Diagnostics
Acquisition likely isn’t a full-blown push into Native American healthcare, consultant Larry Worden says
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