INDICAID(TM) COVID-19 Rapid Antigen Test Receives Emergency Use Authorization From the U.S. Food and Drug Administration

PHASE Scientific

PR91097

 

HONG KONG and GARDEN GROVE, Calif., Aug. 11, 2021 /PRNewswire=KYODO JBN/ --

 

PHASE Scientific International LTD(https://www.phasescientific.com/) (PHASE

Scientific), today announced that its INDICAID™ COVID-19 Rapid Antigen Test

(INDICAID) received Emergency Use Authorization (EUA) from the U.S. Food and

Drug Administration (FDA) on July 29, 2021. The FDA authorized the test for

professional use in point of care CLIA-waived settings in the U.S. for the

qualitative detection of SARS-CoV-2 antigen. Anterior nasal swab specimens may

be collected by a healthcare provider or self-collected under the supervision

of a healthcare professional. In regions outside of the U.S., such as Hong

Kong, the test is authorized as a consumer self-test.

 

INDICAID requires no special instrumentation and can be performed in 20 minutes

with a gentle shallow nasal swabbing vs. the deeper penetration required by

other tests. INDICAID is also one of the first rapid antigen tests to enable

batch sample collection and testing at the point of care due to its unique

sample collection vial which protects the sample throughout the collection and

staging process. The design gives healthcare professionals the option of

collecting a large number of samples concurrently and then quickly testing the

individual samples in batches within a two-hour timeframe. To date, there are

over two million kits sold across 30 countries worldwide.

 

"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," said Dr. Ricky Chiu, founder and chief executive officer of PHASE

Scientific. "We see this U.S. emergency use authorization as recognition of the

importance of our technology and product quality and we are eager to further

expand our reach into more markets to do our part in helping combat the

COVID-19 pandemic."

 

About Phase Scientific International LTD: PHASE Scientific is a high-growth

biotech company founded by a team of bioengineers from UCLA. The organization

is focused on building tools that empower people by giving them better

information about their health. Headquartered in Hong Kong, its footprint

includes research and development, manufacturing and distribution in Hong Kong,

mainland China and Southern California. For more information:

https://phasescientific.com/.

 

SOURCE:  PHASE Scientific

 

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   Caption: PHASE Scientific’s INDICAID COVID-19 Rapid Antigen Test has received FDA’s

Emergency Use Authorization

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