TCA/GENETWORx Labs unveiled a new breakthrough diagnostic Flu A-B/COVID-19/RSV combination test that provides patients with early detection of all three separate respiratory viruses with just one test sample.

Across the country, the coronavirus is exploding with over 13 million cases and President-Elect Joe Biden has warned of a "a very dark winter" with the virus and emphasized the need for more testing.

With people inside homes, businesses, and schools in cold weather months where there is less ventilation, the COVID-19 virus coupled with influenza and RSV (Respiratory Syncytial Virus) pose a formidable and unprecedented infectious disease threat, particularly since these viruses share similar symptoms. To help battle this triple threat, the new TCA/GENETWORx Combo PCR test provides patients the ability to detect strands of influenza A and B, RSV, and COVID-19 all from a single sample.

"If you are showing symptoms such as fever, cough, and shortness of breath, it's important to know whether you or your loved one has COVID-19, influenza, or RSV. The only way to be sure is through diagnostic testing," said William Miller, CEO of GENETWORx Labs. "With this new combination test, healthcare providers can provide an accurate diagnosis to patients and treat them with the appropriate measures. Patients then can observe appropriate quarantine measures to stop the spread."

Last year's flu season which ended in March 2020, had case totals between 39 to 56 million and medical visits between 18 to 26 million, according to estimates from the Centers for Disease Control and Prevention. For RSV, the CDC reports 2.1 million outpatient visits and 57 thousand hospitalizations in children under 5 years of age, with 177 thousand hospitalizations and 14 thousand deaths in adults over 65. COVID-19 cases in the U.S. are over 11 million with deaths over 260 thousand.

The TCA/GENETWORx Flu A-B/COVID Combo Test is a molecular diagnostic PCR test that detects two types of influenza viruses—influenza A and B—and differentiates them from RSV, and SARS-CoV-2, the virus that causes COVID-19. The Flu A-B/COVID Combo Test provided by GENETWORx has a 98 percent accuracy rate for influenza, 99 percent for COVID-19, and 96 percent for RSV.

"The United States is facing an enormous dual health crisis with the COVID-19 pandemic and the simultaneous flu season," said William Miller, CEO of GENETWORx Laboratories. "Having a combination test that detects three different viruses is a healthcare breakthrough for both providers and patients and will save lives. The Combo test is also easier on patients since only one sample is needed for three answers.  GENETWORx is committed to providing the technology and testing that is vital to businesses, colleges, assisted living facilities, and others as they strive to keep their workforce and student populations safe during the pandemic."  

The capability to test for influenza A/B, RSV, and COVID-19 from a single mid-turbinate or nasopharyngeal swab sample means less discomfort for patients when compared with collecting a separate sample for each test. Testing a single sample for several pathogens uses fewer resources and takes less time when compared with running several individual tests on multiple samples to detect different pathogens.

Test results for the new TCA/GENETWORx Combo test will be available in 48 hours. GENETWORx also has one of the fastest results-reporting platforms where patients or providers can easily access test results in an online portal, as well as via text or phone, or through the comprehensive COVID-19 software solution, named Aura.  

Aura software users have expedited turnaround times for the Flu A-B/COVID Combo Test and other GENETWORx COVID-19 tests. The end-to-end digital management system also significantly reduces laboratory process time and helps ensure a compliant, safe, healthy population for healthcare providers, schools, universities, governments, cities, employers, and others.

Moreover, the Aura platform provides user-friendly assistance with all facets needed for comprehensive sequential testing. Aura assists users with finding and scheduling testing including sending reminders, symptom tracking, identification of compliance using QR bar codes, and contact tracing assistance.  

An approval date for a COVID-19 vaccine is still yet to be determined and the flu vaccine is dependent on which strain of influenza is circulating each year. There is currently no vaccine for RSV. Even with the correct strain, the flu vaccine is not 100% reliable. With all the unknowns and risks associated with this upcoming flu and RSV season, the new TCA/GENETWORx test is an important advancement in diagnostic medicine during the pandemic.

GENETWORx is a fully integrated CAP/CLIA certified high complexity molecular diagnostic laboratory. In addition to COVID-19 testing, the company also provides pharmacogenomic DNA genotyping.