Avellino Labs Launches FDA-Recognized COVID-19 Test

Avellino announced its newly developed coronavirus diagnostic test has been validated pursuant to the policy for diagnostics testing during a public health emergency of the United States Food and Drug Administration (FDA) pending the FDA’s independent review. The test uses the company’s existing genetic diagnostics platform to help clinicians diagnose COVID-19, the disease caused by a SARS-CoV-2 virus infection, by identifying and isolating the genetic markers as part of the virus’ genetic sequence previously identified by the U.S. Centers for Disease Control (CDC). The company has set up a helpline for healthcare providers and public health officials at [email protected].
 
The Avellino coronavirus test is called the Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2 for short). Just 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 by collecting cell samples from the patient’s throat and nose by swabs. Samples are then sent by the physician to Avellino’s CLIA certified high-complexity molecular testing laboratory facility in the United States for testing, which takes from 1.5 to 3 hours to perform. Results are then sent back immediately to physicians and/or public health officials who ordered the test. In all, from receipt of the sample to delivery of results can be as short as one to two days.
 
As developed by Avellino’s Chief Laboratory Officer, Connie Chao Shern, Ph.D., the AvellinoCoV2 patent pending test identifies two genetic factors 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.
 
Avellino Group Chairman Gene Lee said, “Because we specialize in molecular diagnostics, we have been able to quickly pivot our health innovations team and focus our efforts on understanding and confronting this global health crisis. By working hand in hand with healthcare providers, public health officials, and with additional resources, we should be able to scale properly and make the test accessible to all.”