Company’s SARS-CoV-2/COVID-19 Test (AvellinoCoV2) – One of the First COVID-19 Tests to Receive EUA – Continues to Play Critical Role in Public Health Efforts
MENLO PARK, Calif. – Avellino Lab USA, Inc. (Avellino) today announced that more than two million of its SARS-CoV-2/COVID-19 tests (AvellinoCoV2) have now been performed in the United States.
Avellino was one of the first private companies in the U.S. to receive an Emergency Use Authorization (EUA) from the FDA for AvellinoCoV2 in March 2020. The test provided much-needed testing capacity during the initial surge of the pandemic in the U.S., in particular among populations in skilled nursing facilities, schools, colleges and government municipalities.
The AvellinoCoV2 test targets the N-gene region of the SARS-CoV-2 virus, which has so far proven to be less prone to mutations seen in COVID-19 variants, helping to prevent false negatives that can occur when targeting areas of the virus that are more susceptible to mutations.
Further supporting local and national public health efforts, Avellino received an EUA in November 2020 for its COVID-19/Flu AvellinoCoV2 Respiratory test, which is designed to differentiate between COVID-19 and the various types of influenza viruses.
For both the AvellinoCoV2 and AvellinoCoV2-Respiratory tests, Avellino processes the tests in the company’s high complexity CLIA-certified lab. The lab can process tens of thousands of tests a day, with further plans to continually increase capacity. This focus on increased capacity helped enable Avellino to quickly respond to the pandemic.
“Just prior to COVID-19, we had begun a limited rollout of our first genetic eye test, AvaGen; however, with the onset of COVID-19, we were able to apply our complex genetic expertise to focus on a novel molecular viral test, navigate the regulatory pathway, modify our CLIA-certified lab and scale rapidly,” said Avellino CEO Jim Mazzo.
He continued, “We have since resumed the launch of our genetic eye test; however, we recognize that COVID-19 may be with us for the long-term, and our respiratory portfolio remains needed and valuable. With SARS-CoV-2 continuing to mutate and respiratory infections prevalent every fall, no one knows how COVID-19 may continue to affect us in the future. What we do know is that we have a talented and nimble team that has demonstrated they are up for the toughest challenges in health.”
Avellino possesses genome sequencing capabilities, which can help in the efforts to track the spread of emerging SARS-CoV-2 variants. Data from this sequencing is reported to the CDC as part of its SPHERES program (SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance), which is aimed at coordinating sequencing efforts nationally in support of larger COVID-19 mitigation efforts.
Avellino Lab USA, Inc. is a global leader in gene therapy and molecular diagnostics at the forefront of precision medicine for eye care. With a long-term mission to develop personalized approaches to improve health and disease management through genomics, the company is developing a transformative genetic diagnostics product pipeline, as well as genetic therapeutics leveraging CRISPR gene editing, to better manage, and potentially cure, inherited diseases. The company also developed the Avellino SARS-CoV-2 RT-PCR diagnostic test to aid in COVID-19 pandemic testing efforts in the US, and was the third private company in the nation to receive EUA for its COVID-19 test. Avellino is headquartered in Silicon Valley, California, with operations in Korea, Japan, China and the UK.
To learn more about Avellino, visit www.avellino.com.