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Genetworx Laboratories Announces New COVID-19 Antibody Test with 99.8 Percent Specificity

Genetworx Laboratories, a leading innovative molecular diagnostic testing laboratory, announced today that the company is now performing COVID-19 antibody testing, in addition to diagnostic testing, for the virus. The Virginia-based company stated that it is providing the new antibody blood test in response to the demand from physicians' offices, emergency management providers, government, assisted living entities, and employers all over the United States. The Genetworx Total Antibody (IgM & IgG) test is 99.8% specific and 100% sensitive.

In addition to the new antibody test, the company further announced a comprehensive instant notification system implemented recently in which patients (who opt in) are notified of their test results immediately – for both antibody and diagnostic testing clients. Once Genetworx receives a patient's sample, the test is performed, and results are available through a patient or physician portal, or via text and voice messaging, within 24-48 hours.

Test results were previously sent directly to providers or third-party contractors. However, now, patients themselves can choose to receive their Genetworx COVID-19 test results automatically by text message or through a new interactive voice response telephone messaging system using a personal cellphone. Additionally, test results can be provided online through a patient portal. A certificate of proof of a test result will also be able to printed through the new online portal for employees as they return to work.

"We understand how important COVID-19 test results are to our patients so Genetworx invested in a system allowing rapid notification so that patients can have a diagnosis in the soonest time possible -- immediately after the Laboratory reads the results—usually within 24-48 hours of receipt of the sample," explained William Miller, CEO of Genetworx and a 20-year veteran of the molecular diagnostic laboratory testing industry. "Like all laboratories in the US, we saw a significant increase in volume recently and have worked tirelessly to implement the new system and be as responsive as possible to our patients and providers," he said.

The Genetworx antibody test, like the diagnostic test, is in the 99th percentile for accuracy and has emergency use authorization from the U.S. Food and Drug Administration. COVID-19 antibody tests utilize a patient's blood sample to detect the presence of specific antibodies to show a past infection with the virus. Nearly all immune competent individuals will develop an immune response following SARS-CoV-2 infection. Like infections with other pathogens, a COVID-19 infection creates IgM and IgG antibodies, which are the most useful for assessing antibody response. A patient's physician and the Centers for Disease Control guidelines will help determine the appropriate response to antibody test results.

Miller says that the last few months have been a once-in-a-lifetime experience for him and his staff.

"It's been very exciting for us to work together and play an important role in battling the coronavirus pandemic. Our company is proud that we pivoted quickly and repurposed part of our facilities back in March in order to conduct widespread COVID-19 testing with a 99 percent accuracy rate. Although it was challenging to keep up with the demand and to innovate in order to get both physicians and patients the information they need at the accuracy level required by the pandemic, Genetworx invested in our patients and, with this new rapid notification system and antibody test for our clients, we can assist the nation in moving forward through the pandemic and back to work."

Genetworx was founded to provide pharmacogenomic DNA genotyping to help provide patients with the right medications, at the right dose, and lower overall healthcare expenditures while delivering the best health outcome. The company is a fully integrated CAP/CLIA certified high complexity molecular diagnostic laboratory.

In 2017, the company was purchased by the national substance use disorder treatment network, Recovery Centers of America ("RCA"). Recovery Centers of America operates seven evidence-based addiction treatment facilities in Massachusetts, Pennsylvania, New Jersey and Maryland and is expanding to Chicago, Indianapolis, and Pittsburgh to meet the growing need for substance use disorder services.

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