Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s 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. Physicians can order the assay now, while the company continues testing.

Physicians can collect cell samples in their offices by swabbing a patient’s nose and throat. Samples will be analyzed in Avellino’s CLIA certified high-complexity molecular testing laboratory facility in Menlo Park, Calif., which is also the location of the company’s U.S. headquarters.

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. CDC.

While Avellino has historically focused on using gene-based diagnostics, data and therapy to address eye disorders and rare diseases, company leadership pivoted to applying its experience in next generation sequencing and genetic test development to address the new coronavirus shortly after the disease first emerged in China.

“We have more than 10 years working with [polymerase chain reaction] technology and can make PCR tests that are very fast and very precise,” said Avellino's Chief Laboratory Officer Connie Chao-Shern. “We looked at the platform recommended by the CDC and quickly developed the RT PCR test.”

Problems with the CDC recommendations

The process had a few hiccups, however. “The CDC recommended three targets on the COVID-19 virus,” Chao-Shern explained. “We discovered one didn’t work. We used their recommended primer probes, our primer probes, and still couldn’t do it. Two or three weeks later the CDC announced that their target didn’t work.”

The unexpected result did not stop the team from continuing to develop the test. “By the time the CDC discovered the problem, we were way ahead, locking down our method and doing optimization. We cross-checked with the WHO website; China, Japan, Germany [had tests] that used one or two targets, though they could be on different locations, different sequences, or different genes.”

In keeping with the recommendations for testing approved under the emergency use authorization, the company conducted in silico testing of the assay against 56 strains discovered worldwide and reported in the National Center for Biotechnology Information database. “We blasted our target probes against those and found the two targets we have that could accurately identify the virus,” Chao-Shern told BioWorld.

“When testing opportunities opened up with the emergency authorization, we quickly submitted our package. Right away, they told us we could start testing while they are reviewing the package,” Chao-Shern said.

As Avellino’s researchers continue working on the assay, they were able to reduce the runtime, speeding time to results. “In all we can finish a run within an hour and a half from extraction to result,” Chao-Shern said. Physicians or health departments can receive results one to days from when the lab receives the sample.

FDA urgency

The FDA is encouraging “early interactions with test developers and will review data on a rolling basis” to help companies develop “the best approach for completing your validation, documentation, and submission of your EUA request.”

Avellino’s experience reflects the urgency felt by the federal agency. The FDA has “been in constant communication with the company and sending questions all weekend,” since the review package for the Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2) was submitted March 5, Chao Shern noted. “That tells me how desperate they are.”

The company is currently working with several private and public partners to find the best path forward for testing and access, said Eric Bernabei, Avellino’s chief sales and marketing officer. “If you have the right test, but people can’t get it, it’s not helping anything. Our goal is to bring this to the largest group of patients possible as soon as possible,” he told BioWorld.

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.”

Other tests proliferating

WHO uses a test developed by the Robert Koch Institute in Germany. Quest Diagnostics and Labcorp have released new tests. Co-Diagnostics’ COVID-19 test has been in use in Europe since mid-February and the company began shipping its test in the U.S. and to 50 other countries in early March.