FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene Therapy

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SALT LAKE CITY—ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox). ROCTAVIAN™, a new gene therapy developed by BioMarin Pharmaceutical Inc., received contemporaneous FDA approval for the treatment of […]

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IONIQ is “Best Diagnostic Testing Solution 2023”

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Salt Lake City, UT, July 7, 2023 –Medtech Breakthrough has awarded IONIQ Sciences the “Best Diagnostic Testing Solution of 2023″ (link). Our mission is to “break through” the screening status quo to catch cancer early. You and your doctor could know in just 20 minutes with no needles, no radiation, and no surgery. Watch this […]

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Myriad Genetics Announces New $90 Million Asset-Based Credit Facility

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SALT LAKE CITY, July 06, 2023 (GLOBE NEWSWIRE) — Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that it has established a new $90 million asset-based credit facility (the “ABL Facility”) with JPMorgan Chase Bank, N.A. as administrative agent and issuing bank, and the other lender parties thereto […]

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Renalytix Appoints Financial Executive Catherine Coste to its Board of Directors

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LONDON and SALT LAKE CITY, July 03, 2023 (GLOBE NEWSWIRE) — Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to commercialize an FDA approved artificial intelligence (AI) enabled prognostic blood test for individuals with Type 2 diabetes and chronic kidney disease, announces the appointment of Catherine Coste to the Company’s Board of Directors, effective June 30, 2023. […]

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FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions

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On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s […]

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