Hamilton, NJ /PRNewswire/ - Medical Diagnostic Laboratories, L.L.C., (MDL), a Genesis Biotechnology Group® (GBG) member company and CLIA-certified, CAP-accredited laboratory specializing in high-complexity, state-of-the-art, automated DNA-based molecular analyses, expanded availability of its molecular test for SARS-CoV-2 (COVID-19) into New York state after receiving approval from the Wadsworth Center, New York State Department of Health. This expansion is accompanied by an increase in their capacity for testing, which is available nationwide to hospitals, health systems, organizations, and physicians.
Coronavirus Disease 2019 (COVID-19) is an acute respiratory disease caused by a viral infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus, which has infected over 4 million people and caused deaths of approximately 300,000 people worldwide, has rapidly escalated to pandemic status since it first appeared in Wuhan, China, in December 2019. The SARS-CoV-2 virus spreads very quickly, and a subset of severely infected individuals require hospitalization. As a disease, COVID-19 shows considerable symptomatic variation. Individuals may have no symptoms at all, while others may present with a mild cough and fever. Still, others may experience severe pneumonia and respiratory failure, specifically in patients with pre-existing conditions such as respiratory distress, diabetes, and cardiovascular disease.
MDL's SARS-CoV-2 (COVID-19) by Real-Time Reverse Transcription PCR (CDC N1, N2, RP targets) previously approved by the New Jersey State Department of Health on March 16, 2020, is offered under the Food and Drug Administration (FDA) emergency use authorization (EUA). MDL has now built up the capacity for this Reverse Transcription Real-Time PCR test to approximately 3,000 tests per day and completes those tests within an average of 1 to 2 days from the time the specimen is received.
According to Dr. Eli Mordechai, Chief Executive Officer (CEO), "We recognize the critical need for accurate diagnostic testing to manage COVID-19. We have been able to rapidly pivot our resources and apply our experience to expand our capacity and increase availability to help meet testing needs. Making diagnostic tools available to health care professionals is crucial for detecting and mitigating the spread of the coronavirus and keeping our communities healthy."
MDL is a CLIA-certified, College of American Pathologists (CAP)-accredited infectious disease laboratory specializing in high-complexity, state-of-the-art, automated, high throughput, DNA-based molecular analyses. Using unique molecular techniques, MDL provides clinicians from many specialties valuable information to assist in the diagnosis, evaluation, and treatment of viral, fungal, and bacterial infections. MDL is a member of the Genesis Biotechnology Group located in Hamilton, New Jersey, in "Einstein's Alley," the research and technology corridor of New Jersey.
GBG is a consortium of vertically-integrated corporate research entities, with a mission of improving patient care through cross-linking their expertise, dedication, and vision in the fields of drug discovery, personalized and tailored clinical diagnostics, and through the development, manufacturing, and distribution of unique biotechnology-based products.
To find out more, please visit www.mdlab.com.