PerkinElmer Receives FDA Emergency Use Authorization for Respiratory SARS-CoV-2 Panel
October 07 2021 - 8:30AM
Business Wire
RT-PCR test detects and differentiates
SARS-CoV-2, influenza A, influenza B and respiratory syncytial
virus
PerkinElmer, Inc. (NYSE: PKI) announced today that the U.S. Food
and Drug Administration (FDA) has issued Emergency Use
Authorization (EUA) for the PKamp™ Respiratory SARS-CoV-2 RT-PCR
Panel 1 assay. Qualified laboratories can immediately begin using
this single test for the simultaneous qualitative detection and
differentiation of SARS-CoV-2, influenza A, influenza B and
respiratory syncytial virus (RSV) isolated from nasopharyngeal
swabs, anterior nasal swabs and mid-turbinate swabs.
COVID-19, flu and RSV infections are highly contagious and often
cannot be differentiated based on symptoms alone. The U.S. Centers
for Disease Control and Prevention encourages COVID-19 testing
laboratories to adopt a multiplex method that facilitates detection
and differentiation of SARS-CoV-2 and influenza viruses. A
multi-analyte test such as the PKamp Respiratory SARS-CoV-2 RT-PCR
Panel 1 assay allows laboratories to conserve precious resources by
avoiding multiple tests on samples collected from individuals
suspected of respiratory viral infection consistent with
COVID-19.
“As we enter the flu season, this timely emergency use
authorization will be welcome by laboratories that are looking to
test for common respiratory illnesses alongside COVID-19,” said
Arvind Kothandaraman, managing director of specialty diagnostics at
PerkinElmer. “The new test will help to alleviate confusion arising
from similar symptoms caused by these infections and reduce further
strain on the healthcare system during a pandemic.”
Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a,
that meet requirements to perform high complexity tests.
PerkinElmer also has CE marking for a multi-analyte respiratory
panel that tests for COVID-19 – the PKamp™ Respiratory SARS-CoV-2
RT-PCR Panel assay has clearance to be marketed as an in vitro
diagnostic (IVD) device in more than 30 countries by meeting the
requirements of the European In Vitro Diagnostic Directive
(IVDD).
PerkinElmer’s comprehensive SARS-CoV-2 portfolio includes high
throughput RNA extraction, RT-PCR, workflow automation, ELISA,
chemiluminescence, time-resolved fluorescence and lateral flow
based antigen as well as serology testing.
About PerkinElmer PerkinElmer enables scientists,
researchers, and clinicians to address their most critical
challenges across science and healthcare. With a mission focused on
innovating for a healthier world, we deliver unique solutions to
serve the diagnostics, life sciences, food, and applied markets. We
strategically partner with customers to enable earlier and more
accurate insights supported by deep market knowledge and technical
expertise. Our dedicated team of about 15,000 employees worldwide
is passionate about helping customers work to create healthier
families, improve the quality of life, and sustain the wellbeing
and longevity of people globally. The Company reported revenue of
approximately $3.8 billion in 2020, serves customers in 190
countries, and is a component of the S&P 500 index. Additional
information is available at www.perkinelmer.com.
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Media Relations: Chet Murray (781) 663-5719
chet.murray@perkinelmer.com Investor Relations: Steve Willoughby
(781) 663-5677 steve.willoughby@perkinelmer.com
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