February 5, 2021 – PathGroup is pleased to announce the availability of a new serologic test for the detection of human antibodies to the SARS-CoV-2 spike protein (S) receptor binding domain (RBD), the viral pathogen associated with SARS-CoV-2 (COVID-19). The Roche Elecsys® Anti-SARS-CoV-2 S antibody test is for the qualitative and semi-quantitative detection of total antibodies (IgG, IgA and IgM) to SARS-CoV-2 in serum from individuals with prior COVID-19 infection and is intended to aid in identification of patients with an adaptive immune response to SARS-CoV-2 indicating prior infection to the SARS-CoV-2 virus. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for this test.
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Effective today, January 27, 2021, PathGroup is pleased to announce a new multiplex nucleic acid amplification molecular diagnostic test (NAAT) for Influenza A/B & SARS-CoV-2 on the Roche cobas® instrument. This real time RT-PCR based assay is intended for the simultaneous qualitative detection and differentiation of Influenza A virus, Influenza B virus, and/or SARS-CoV-2 RNA from appropriately collected specimens from individuals suspected of associated respiratory viral infection. This test has been issued an Emergency Use Authorization (EUA) by the FDA.
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The American Medical Association makes updates to the Current Procedural Terminology (CPT) codes each year. Effective January 1, 2021, there will be CPT code changes for laboratory tests and/or components of tests provided by PathGroup.
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NASHVILLE, Tenn. – (September 2, 2020) – PathGroup, one of the largest private providers of pathology, clinical and molecular laboratory services in the United States, today announced the award of a funding grant from the National Institutes of Health (NIH) under the Rapid Acceleration of Diagnostics (RADx SM) program. PathGroup will utilize the funds granted by the NIH to expand its high-throughput COVID-19 testing laboratory, becoming one of the nation’s “mega-labs” with the capability of performing up to 80,000 SARS-CoV-2 tests per day for COVID-19, with results expected to be delivered within 24 hours.
The RADxSM initiative supports the development, production scale-up, and deployment of accurate, rapid SARS-CoV-2 tests across the country. The RADx-Advanced Technology Platforms (RADx-ATP) program assists in the expansion of labs that can significantly scale the number of COVID-19 tests that can be performed each day in the United States.
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NASHVILLE, Tenn. – (June 23, 2020) – PathGroup, one of the largest private providers of pathology, clinical and molecular laboratory services in the United States, today announced that the company has been selected as an early access partner for the launch of Illumina’s new sequencing-based COVID-19 test, COVIDSeq™. COVIDSeq accommodates more than 3,000 test samples per run, allowing for a substantial increase in testing capacity.
Illumina, a global leader in sequencing technologies, received the first Emergency Use Authorization from the U.S. Food and Drug Administration for a sequencing-based test on June 9, 2020. COVIDSeq is being rolled out via a limited number of early access sites around the world including PathGroup’s comprehensive 140,000 square foot Nashville-area laboratory.
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NASHVILLE, Tenn. – (June 1, 2020) – PathGroup, one of the largest private providers of pathology, clinical and molecular laboratory services in the United States, today announced the availability of a new, minimally-invasive nasal swab collection option as a part of its comprehensive SARS-CoV-2 (COVID-19) testing program.
Many current molecular diagnostic COVID-19 tests rely on a nasopharyngeal (NP) swab, which can cause discomfort for patients during the collection process. The new nasal swab collection option is more comfortable for patients and easier for healthcare providers to administer.
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Effective May 27, 2020, PathGroup is pleased to announce the availability of a new serologic test for human antibodies to SARS-Cov-2, the viral pathogen associated with COVID-19 (PathGroup Test Code: COVIDAB). On May 3, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Roche Elecsys® SARS-CoV-2 antibody test. The test is for the qualitative detection of total antibodies (including IgG, IgA and IgM) to SARS-CoV-2 in serum from individuals with prior COVID-19 infection. This test may aid in identification of patients with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection to the SARS-CoV-2 virus.
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It goes without saying that we are all facing unprecedented times in the face of the current COVID-19 epidemic. Like you, PathGroup is an essential component of the U.S. healthcare system and we remain fully operational to support the laboratory testing services of you and your patients.
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Effective March 16, 2020, PathGroup will begin to offer testing for Coronavirus Disease 2019 (COVID-19). This test is to be ordered only for individuals who meet the Centers for Disease Control and Prevention (CDC) Coronavirus Disease 2019 (COVID-19) clinical and/or epidemiological criteria for testing. Because this criteria may change as more is learned about the virus, please refer directly to the CDC website for the most up-to-date patient testing criteria: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
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More than 50 million Americans suffer from allergies every year making allergies the sixth leading cause of chronic illness in the United States. Allergies are a common, yet overlooked, disease and the most common health issue that affects children in the U.S. An estimated 4.2 million children in the U.S. have a food allergy to things like peanuts, eggs, milk, wheat, tree nuts, fish and shellfish.
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