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FDA Nod for Phase Scientific’s COVID Test

Phase Scientific International—a biotech startup based in Garden Grove and Hong Kong—announced on Aug. 10 its Indicaid COVID-19 Rapid Antigen Test received Emergency Use Authorization (EUA) from the FDA in point-of-care applications.

“We see this U.S. emergency use authorization as recognition of the importance of our technology and product quality and we are eager to expand our reach across the U.S. and into other international markets to do our part in helping combat the COVID-19 pandemic,” founder and CEO of Phase Scientific Dr. Ricky Chiu said in a statement.

Indicaid is a nasal swab test that detects the SARS-CoV-2 antigen in individuals suspected of contracting the virus within five days of symptom onset. Results are available within 20 minutes, according to the company.

The test is performed via “a gentle shallow nasal swabbing vs. the deeper penetration required by other tests,” Phase Scientific notes.

Self-Administered Overseas

Two million Indicaid kits have already been supplied across 30 countries. In some regions outside of the U.S., such as Hong Kong, it’s authorized as a consumer self-test.

“Our test has been globally adopted and utilized to meet a variety of emergency testing needs. From the Hong Kong government using Indicaid for healthcare worker’s weekly screenings, to usage across shopping malls, supermarkets and schools worldwide, our rapid test has proved to be both effective and efficient,” Chiu said.

In the U.S., specimens can now be collected by a healthcare provider or self-collected under the supervision of a healthcare professional, following the August FDA approval.

UCLA Alumni

Phase Scientific was founded in 2015 by UCLA engineers Daniel Kamei, Benjamin Wu and Chiu.

Since its formation, it’s raised $23 million in funding from the Bill and Melinda Gates Foundation, the U.S. National Science Foundation, the U.S. National Institutes of Health and government agencies in Hong Kong, Chiu told the Business Journal.

The privately-held company has developed a liquid biopsy technology that concentrates and purifies target molecules in samples, improving the accuracy of diagnostic tests.

“Our technology is very unique,” Chiu told the Business Journal. “Simply put, higher concentration equals more accuracy.”

Phase Scientific’s liquid biopsy methodology has a vast application, officials say, including cancer screenings, prenatal tests, and now, COVID-19 rapid antigen tests.

Funding Plans

While Indicaid is currently authorized in the U.S. for professional use, Phase Scientific aims to make it available to the U.S. consumer market once it obtains the proper certifications, Chiu told the Business Journal.  

“The advantages of Indicaid are essential for allowing efficient testing workflows for point-of-care settings that require high volume screening such as schools, acute and long-term healthcare facilities and community sites,” Chiu said, adding that its self-collection sample vial makes it one of the first rapid antigen tests to enable batch sample testing within a two-hour timeframe.

Phase Scientific is also about to close a $40 million Series A round with a pair of institutional investors, Chiu said.

With these funds, the company hopes to help combat the pandemic and continue its research in diagnosing infectious diseases such as STDs and tooth decay. 

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