- Source : PR Newswire
- Date : 2022-01-13
- Event type : Approved
- Companies : Premier Medical, Inc., RapidRona Inc.
FDA Grants Emergency Use Authorization to Premier Medical Laboratory Services for at-Home COVID-19 Test
GREENVILLE, S.C., Jan. 13, 2022 /PRNewswire/ -- Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19 response. They have also implemented one of the largest variant surveillance initiatives in the country with the capability to sequence up to 42,000 specimens per day. Now, they have been granted Emergency Use Authorization (EUA) from the Food and Drug Administration to process results for at-home COVID-19 tests.
The RT-PCR-based SARS-CoV-2 assay now authorized by the FDA is designed for RapidRona at home tests which can be ordered online at www.rapidrona.com. RapidRona enables those who would like to test for COVID-19 to collect their own sample at home by a minimally invasive nares swab and then send the specimen with prepaid shipping to the lab for processing of results. Polymerase Chain Reaction (PCR) tests have been known throughout the pandemic as the gold standard of testing methods due to the highly accurate results that they provide.
"Our scientists have worked diligently to take the steps necessary in receiving the EUA for this test," said Kevin Murdock, Founder and CEO of Premier Medical Laboratory Services. "We did this because we know how important it is to enable the population to more easily access reliable COVID-19 tests with fast turnaround times from home. We're proud that this is another way we can provide effective solutions for COVID-19 management."
At-home COVID-19 tests have been reported as difficult to find during the Omicron surge. The EUA attained by PMLS will allow more people the ability to test and mitigate the spread of the virus. Because some countries around the world only accept incoming travelers who have taken a RT-PCR test with a negative result, RapidRona is the choice for at-home testing among travelers. Returning schools and businesses can also reduce viral transmission rates utilizing RapidRona's sample collection method designed for improved comfortability, keeping infected employees, students, and staff to a minimum.
PMLS is part of a house of brands under Diversified Medical Healthcare which manufacture testing supplies, develops medical data management software, and provides PPE to seamlessly meet the needs of organizations without delay or disruption.
During the pandemic, PMLS has:
- Processed millions of COVID-19 tests with a turnaround time of 24 hours or less
- Served as the choice processing lab for Health and Human Services testing sites
- Been the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments spanning from coast to coast
To order a test, please visit www.rapidrona.com. For more information on Premier Medical Laboratory Services, please visit www.PreMedInc.com.
ABOUT PREMIER MEDICAL LABORATORY SERVICES: Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS), easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry and patient-friendly billing. Their expansive testing menu includes advanced Cardiovascular Testing, Diabetes panels, Pharmacogenomics, COVID-19 testing, Women's Wellness panels, Allergen Specific Ige Blood Testing, and Toxicology. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.
SOURCE RapidRona; Premier Medical Laboratory Services