Operations for the AvellinoCoV2 test will expand into the genetic diagnostics lab as used for the company’s newly released AvaGen™ test used by ophthalmologists and optometrists to diagnose and monitor patients with keratoconus and other corneal dystrophies. The AvellinoCoV2 test helps clinicians diagnose COVID-19, the disease caused by a SARS-CoV-2 virus infection, by identifying and isolating the genetic markers as approved by the CDC and the FDA.
Avellino Group Chairman Gene Lee said, “We appreciate the support from eye care professionals who are now using the AvaGen genetic test to care for their corneal patients. We understand the breakthrough importance of the AvaGen test in treating patients with complex corneal conditions. Avellino will restart production of the AvaGen genetic test as soon as we have fulfilled our public health obligation surrounding the coronavirus pandemic.
About The Avellino SARS-CoV2/COVID-19 Genetic Test
On March 5, 2020, Avellino completed the validation process for AvellinoCoV2 according to the FDA issued guidance, “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.” The test must be ordered by a physician and cannot be made available directly to the public. The test is performed in the physician’s office or at a public collection facility by collecting cell samples from the back of the patient’s throat and the nose via swabs. Samples are then sent by the healthcare provider to Avellino’s CLIA certified high-complexity molecular testing laboratory facility in Menlo Park for testing. Tests take approximately 1.5 to 3 hours to perform. Negative results are sent back immediately to the physician and/or public health officials who ordered the test. Positive results are subject to secondary confirmation testing. Results may be available in as little as six hours or the next day in most cases.
The AvellinoCoV2 patent pending test identifies two N gene markers that test the SARS-CoV-2 virus expression. Original CDC guidance specified that coronavirus testing required three specific genetic parts. Avellino has confirmed through its validation process that only two of these parts are necessary in identifying COVID-19. As a result, the company has the technology today to quickly identify the two genetic parts required to confirm the presence of COVID-19.
Conventional COVID-19 diagnostics face many issues, including the difficulty in identifying patients where only few antibodies are present. Therefore, a genetic test such as the AvellinoCoV2 test provides clinicians and public health officials with a valuable diagnostic tool. That said, while a positive result from the AvellinoCoV2 test is indicative of an active infection, it does not necessarily rule out a bacterial or other viral infection. Similarly, a negative result from the AvellinoCoV2 test does not necessarily preclude the presence of the COVID-19 virus – in that potential issues with sample collection and other factors common to all diagnostic tests can affect results. Clinicians are strongly recommended to use clinical observation, patient history, and their best medical judgment in making a final diagnosis and treatment decisions.