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