SAN DIEGO, Feb. 7, 2018 /PRNewswire/ -- Mesa Biotech Inc., a
privately held, molecular diagnostic company that has developed an
affordable PCR (polymerase chain reaction) testing platform
designed specifically for point-of-care (POC) infectious disease
diagnosis, today announced that it has received 510(k) clearance
and Clinical Laboratory Improvements Amendments (CLIA) waiver from
the U.S. Food and Drug Administration (FDA) for its Accula™ Flu
A/Flu B test. The company's Flu A/Flu B test cassette will be its
first available test in the U.S. market.
"The Flu A/Flu B product is the first test cassette on our PCR
testing platform to receive FDA clearance. This announcement
follows our CE Mark certification and launch of our Flu A/Flu B
test last month in Europe," said
Dr. Hong Cai, co-founder and CEO of
Mesa Biotech. "This is an outstanding validation of our testing
platform and we remain focused on additional product development
and commercialization of our expandable PCR system."
According to the World Health Organization (WHO), annual
influenza epidemics are estimated to result in about three to five
million cases of severe illness, and 250,000 to 500,000 deaths.
Diagnosis of influenza is difficult because initial symptoms can be
similar to other upper respiratory virus infections. The FDA,
Centers for Disease Control (CDC), and WHO all acknowledge that
existing POC immunodiagnostic tests perform poorly. Rather,
molecular testing is recommended, as influenza is a rapidly
evolving virus. Further, because antiviral medications for
influenza are only effective when taken within 48 hours of symptom
onset, rapid diagnosis is required to direct therapy for these
viral infections.
CLIA establishes quality standards for laboratory testing to
ensure the accuracy and reliability of patient test results.
CLIA waived tests must meet stringent quality requirements to be
used in non-laboratory POC settings. The CLIA-waived Accula Flu
A/Flu B test brings PCR testing to the POC providing a qualitative
result in approximately 30 minutes to guide same day treatment
decisions. The Accula Testing System offers
the simplicity, convenience and procedural
familiarity of traditional POC rapid immunoassays, while
providing the superior sensitivity, specificity and information
content of laboratory-based PCR testing. The Accula Flu A/Flu B
test is indicated for use with nasal swab collection that is less
invasive than nasopharyngeal swabs and allows for a more
comfortable specimen collection experience for the patient.
Mesa Biotech entered a strategic alliance in early November with
Sekisui Diagnostics for exclusive product distribution rights in
the U.S. and Canada. Leveraging
Sekisui Diagnostics' established channels and strong reputation
among healthcare providers, Mesa Biotech will have immediate access
to distribution into North America
markets. The Accula™ Flu A/Flu B test will be marketed by Sekisui
Diagnostics under the Silaris™ brand.
About Mesa Biotech Inc.
Mesa Biotech designs, develops and manufactures next generation
molecular diagnostic tests, bringing the superior diagnostic
performance of nucleic acid PCR amplification to the point-of-care
(POC). Mesa Biotech's Accula™ System consists of a
portable, palm-sized dock and a disposable, assay-specific test
cassette. This patented system will allow healthcare professionals
to access actionable, laboratory-quality results at the POC with
greater sensitivity and specificity than current infectious disease
rapid immunodiagnostic tests. Mesa Biotech's technology development
has been funded to date by a series of grants and capital
investments. For more information visit
http://www.mesabiotech.com.
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SOURCE Mesa Biotech Inc.