The new coronavirus diagnostic test applies Avellino’s existing genetic diagnostics platform to assist clinicians diagnose COVID-19
Avellino Labs has announced the availability of a newly developed coronavirus diagnostic test, which is recognised by the US Food and Drug Administration (FDA).
Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2) is a new genetic test, which has been validated pursuant to the policy for diagnostics testing during a public health emergency of the FDA.
The new test applies Avellino’s existing genetic diagnostics platform to assist clinicians to diagnose COVID-19, the disease that resulted due to SARS-CoV-2 virus infection, by detecting and separating the genetic markers as part of the virus’ genetic sequence earlier identified by the US Centers for Disease Control (CDC).
The company has completed the FDA validation process for AvellinoCoV2 test
The Avellino coronavirus test, which has completed the validation process, will be provided only to the physicians and not directly to the public.
Avellino’s test will be carried out in the physician’s office by gathering cell samples from the patient’s throat and nose by swabs.
Later, the samples will be shifted to Avellino’s CLIA certified high-complexity molecular testing laboratory facility in the US for testing, which will be completed within three hours.
The results from the test will be sent back immediately to physicians or public health officials who ordered the test.
The patent-pending AvellinoCoV2 test detects two genetic factors, which test the SARS-CoV-2 virus expression.
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.”
Separately, Global life sciences company LabCorp has introduced a test for COVID-19, in a bid to help better deal with the current public health crisis.