Withdrawal of FDA EUA for CDC 2019-Novel Coronavirus RT-PCR Diagnostic Panel

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have…

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Parexel Snapped Up, Again, as Goldman Sachs, EQT Spend $8.5B on the CRO

The rumors were true: Whispers grew this year that Parexel, owned for the past four years by Pamplona Capital, was seeking a sale or an IPO. Today, the whispers stopped as the CRO loudly declared it is being bought out for $8.5 billion. The suitors and soon-to-be owners are the Swedish investment firm EQT Private Equity and the…

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China Embraces Decentralized Clinical Trial Solutions

Surveys show patients, sponsors and CROs in Chinasee the benefits of virtual and hybrid trials. Concernsremain around regulatory gaps, digital data collectionand study logistics. View White PaperBy MAGGIE MA, Director of Clinical Operations – IQVIA, China

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FDA Authorizes New Device to Help Diagnose Pediatric Autism

Posted 02 June 2021 | By Joanne S. Eglovitch  The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years. The device was developed by Cognoa, a company based in Palo Alto, CA, that…

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Mirimus, Inc. Announces Publication of Scientific Paper Highlighting Pooled Saliva-Based Testing as an Effective, Cost-Efficient Approach to COVID-19 Surveillance Testing for Schools

NEW YORK, Feb. 22, 2021 /PRNewswire/ — Mirimus, Inc., a leader in conducting high-volume, high-quality PCR testing, today announced the publication of a scientific paper, titled, “Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections in K-12 Schools and Universities,” available for preprint on MedRxiv as it undergoes scientific peer review for potential publication. The paper…

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RADx Tech Inks Additional Contracts for COVID-19 Tests and Supplies

January 13, 2021The National Institutes of Health has awarded three new contracts totaling $36.7 million for the development of new COVID-19 diagnostic testing technologies and production of specimen collection kits and swabs. The Rapid Acceleration of Diagnostics (RADx) initiative has advanced the scale-up of 25 testing projects since July 2020, which now include lab-based, point-of-care,…

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First Over-the-Counter Covid-19 Test Gets FDA Clearance

The U.S. Food and Drug Administration on Tuesday authorized a Covid-19 test that can be administered and processed at home, the first such test allowed to be sold over-the-counter at drugstores or other retail locations without a prescription. The antigen test, made by Ellume USA LLC, is a single-use, disposable test that searches for pieces…

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Streck Cell-Free DNA BCT® Receives U.S. FDA De Novo Clearance

LA VISTA, Neb., Sept. 11, 2020 /PRNewswire/ — Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use…

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