GENETWORx Laboratories, a Virginia-based molecular laboratory certified in fifty states, announced today that it will begin shipping at least 800 COVID-19 tests a day with the ability to increase capacity to 5,000 tests per day and up to 150,000 per month during April.
The company also stated that it will have the capability of providing results from the GENETWORx COVID-19 tests to patients in 24 hours upon receipt of sample.
The GENETWORx test follows the Centers for Disease Control (“CDC”) approved Assay kits required for sample testing for the Coronavirus genome. Since the outbreak of the coronavirus, GENETWORx has been working diligently to adapt their system to allow accurate, efficient testing of hundreds of samples for the COVID-19 genome in a few hours per run.
GENETWORx is working within the emergency use authorization guidelines from the United States Food and Drug Administration (“FDA”) to specifically conduct COVID-19 testing. GENETWORx is a CLIA-certified laboratory, owned by Recovery Centers of America, that meets regulatory requirements to perform high-complexity testing using their validated tests. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (“CLIA”).
GENETWORx Laboratories conducts a wide variety of molecular laboratory diagnostic and clinical testing services. Due to the extreme nature of the COVID-19 emergency, the company has repurposed a portion of their lab so that rapid accurate analysis of COVID-19 samples can be performed in response to the national need.
“We want to do our part in contributing our expertise to help in the nation’s battle against the coronavirus. The technology we have developed not only allows us to mass produce these much needed COVID-19 tests but also ensures an accurate test result in a timely 24-hour response time from receipt of the sample,” explained William Miller, CEO of Genetworx and a 20-year veteran of the molecular diagnostic laboratory testing industry.
GENETWORx is certified by the College of American Pathology (“CAP”). The CAP accreditation is the gold standard awarded to clinical laboratories that exceed inspection qualifications and ensures a consistent level of service that positively impacts patient care. GENETWORx is both CAP-accredited and CLIA-certified for high complexity laboratory testing in all fields of service.
GENETWORx provides healthcare professionals with tools to individualize treatment plans for patients using their DNA map. The company was founded to provide pharmacogenomic DNA genotyping to help provide the right medications, at the right dose, and effectively lower overall healthcare expenditures while delivering the best health outcome for the patient. GENETWORx has since expanded into the infectious disease and clinical chemistry fields to become a fully integrated CAP/CLIA certified high complexity molecular diagnostic laboratory.
The company has a reputation as a high quality innovative provider of laboratory services and, in 2017, GENETWORx was purchased by the national substance use disorder treatment network, Recovery Centers of America (“RCA”). RCA utilizes GENETWORx laboratories to provide a comprehensive panel of clinical and general wellness tests that are included in the cost of RCA inpatient services in most states; a service that is normally surcharged heavily in the industry. Recovery Centers of America operates seven evidence-based addiction treatment facilities in Massachusetts, Pennsylvania, New Jersey and Maryland and is expanding to Houston, Chicago, Indianapolis, and Pittsburgh to meet the growing need for substance use disorder services.