KIDNEY HEALTH INITIATIVE URGES INVESTIGATORS TO INCLUDE PEOPLE WITH KIDNEY DISEASES IN CLINICAL TRIALS FOR CORONAVIRUS 2019 (COVID-19) THERAPIES

People with kidney diseases are often excluded from clinical trials because of the complexity and high morbidity of kidney disease.

COVID-19 puts people with kidney diseases at a two to sixteen-fold increased risk of severe symptoms.

All investigators should include people with kidney diseases when developing vaccines, preventative therapies or treatments related to COVID-19.

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FDA Approves First At-Home Saliva Collection Test for Coronavirus

Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The decision follows the FDA’s recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.

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New Rutgers Saliva Test for Coronavirus Gets FDA Approval

The FDA has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency. The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs.

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FDA Approves First Plasma Therapy for Houston Methodist COVID-19 Patient

Houston Methodist received FDA approval Saturday to become the first academic medical center in the nation to transfuse donated plasma from a recovered COVID-19 patient into a critically ill patient. This treatment was fast-tracked to the bedside over the weekend as the death toll in the COVID-19 pandemic soared to more than 2,000 people across the United States, with more than 100,000 Americans sick from the virus.

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AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

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