Temporarily Suspending Production of the AvaGenTM Test For Keratoconus And Corneal Dystrophies
MENLO PARK, CALIFORNIA (March 19, 2020) — Avellino announced today that it is adding additional production shifts for its newly developed coronavirus diagnostic, the Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2, for short). The AvellinoCoV2 ultra-rapid genetic test is in increasing demand by health systems, public health services, and first-responders because of its speed, accuracy, and ability to detect coronavirus in patients who are asymptomatic. In order to meet growing public health demand, the company is temporarily suspending sequencing operations of its AvaGen genetic test that identifies the risk of developing keratoconus and the presence of corneal dystrophies.
Operations for the AvellinoCoV2 test will expand into the genetic diagnostics lab as used for the company’s newly released AvaGenTM 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. Ophthalmologists and optometrists can contact Avellino at +1 (650) 396-3741 or at www.avellino.com/en/contact for assistance.
Helpline For Healthcare Providers And Public Health Officials – Hospitals, health systems, physicians, labs, and public health officials can get further information on the AvellinoCoV2 test by contacting Avellino’s Coronavirus hotline at +1 (650) 396-3741 or by email at info@AvellinoCoronaTest.com. You can also visit www.AvellinoCoronaTest.com.
About The Avellino SARS-CoV2/COVID-19 Genetic Test – 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 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.
About Avellino – Avellino Lab USA, Inc. is a global leader in gene therapy and molecular diagnostics and is at the forefront of precision medicine for eye care. The company is pioneering CRISPR gene editing to manage and potentially cure inherited diseases. Avellino is headquartered in Silicon Valley, California, with operations in Korea, Japan, China, and the UK. To learn more about Avellino, please visit https://www.avellino.com/en/ and www.AvellinoCoronaTest.com.