Avellino Launches Combination Test That Detects COVID-19, Respiratory Syncytial Virus (RSV), Influenza A and B

MENLO PARK, Calif.--(BUSINESS WIRE)-- Avellino Labs USA, Inc. (Avellino), a leader in genetic molecular diagnostics, has launched AvellinoCoV2 - Respiratory Test, a multi-panel RT-PCR-based virus assay that accurately detects four viral infections in one patient sample - COVID-19, respiratory syncytial virus (RSV), influenza A and influenza B.

The expanded panel has 100 percent sensitivity for RSV and influenza A and B, 100 percent accuracy for influenza A and B, and more than 99 percent accuracy for RSV. For the COVID-19 panel, by analyzing the N gene that is minimally affected by viral mutation, the test accurately detects the presence of the Omicron variant (including BA.2), as well as all other known COVID-19 variants. The laboratory developed test (LDT) meets all applicable CLIA requirements for high complexity testing.

The test can also detect “flurona,” a term used for a co-infection of COVID-19 and influenza, or any combination of detectable viruses (COVID-19, influenza A, influenza B, and RSV). The first cases of flurona were detected in Texas and California on January 5.

RSV is a respiratory virus that mostly affects the very young, older adults and immunocompromised individuals and is spread via droplets that travel through the air. Symptoms include a runny nose, coughing, sneezing and wheezing, and can lead to pneumonia or, in infants and very young patients, bronchiolitis, an inflammation of lung airways. According to the Centers for Disease Control and Prevention (CDC), annually in the United States there are approximately 58,000 hospitalizations and 14,000 deaths among individuals 65 in older due to RSV.

“We are in an unprecedented cold and flu season, with COVID-19, RSV and the emerging flurona infections as continued health hazards,” says Avellino Chief Scientific Officer Nazneen Aziz, PhD. “The expanded AvellinoCoV2 - Respiratory Test supports the CDC’s notice last June to expand RSV testing, as well as the physician need to test for both COVID-19 and influenza, which is now even more important with the emergence of flurona. With accurate and early diagnosis medical care professionals can make appropriate patient management decisions and better utilize medical resources.”

In response to a rare increase of summer month cases of RSV, in particular in Southern states, in June of last year the CDC released a health advisory for expanded testing of RSV for patients with acute respiratory illness who test negative for SARS-CoV-2. In addition, last August, Texas Children’s Hospital reported that 55 percent of hospitalized pediatric patients tested positive for both RSV and COVID-19.

The Company also distributes a rapid antigen COVID-19 test that can detect the presence of SARS-CoV-2 and an antibody test kit that can detect the presence of antibodies to the S protein of the virus acquired through vaccinations or past infections from SARS-CoV-2. In addition, Avellino conducts surveillance of the different variants circulating in the community via whole genome sequencing of positive samples in its database. Variants of concern and variants of interest are reported to the appropriate federal and California state health agencies.

Test samples are collected via a mid-turbinate nasal swab and sent to Avellino’s high-complexity CLIA certified laboratory for analysis. Located in Menlo Park, the laboratory operates 24/7, has processed nearly 3 million of its COVID-19 tests to date and can process up to 30,000 tests a day.

About Avellino

Avellino Lab USA, Inc. is a global leader in genetic 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 (AvellinoCoV2) to aid in COVID-19 pandemic testing efforts in the US and was the first private, independent company in the US to receive EUA authorization 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.

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