PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva & Sample Pooling to Test Symptomatic & Asymptomatic Individuals
20 November 2020 - 08:00AM
Business Wire
Non-invasive sample collection and batch
processing to test symptomatic and asymptomatic individuals – a
breakthrough in COVID-19 testing
PerkinElmer, Inc. announced today that its PerkinElmer®
SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the
use of saliva as specimen type and the option to pool up to five
specimens collected from individuals suspected of COVID-19 or
asymptomatic individuals.
SARS-CoV-2 testing using saliva is less invasive, reduces the
risk of exposure to healthcare workers involved in sample
collection and need for frequent replacement of personal protective
equipment.
Labs in countries accepting CE mark now have the option to
accept saliva specimens and implement sample pooling using the
PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay. Sample pooling using
saliva specimens is a critical advancement made possible by
PerkinElmer’s chemistry and stringent manufacturing systems. The
PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay is built on the most
sensitive SARS-CoV-2 test with the lowest limitation of detection
in the market, according to the FDA’s reference panel comparative
data.
The assay originally obtained its CE mark in the spring of
2020.
“To strike the right balance between keeping the world economy
moving while ensuring safe practices, governments and private
organizations are working tirelessly to increase the number of
times individuals are tested for COVID-19,” said Masoud Toloue,
Ph.D., Vice President & General Manager, Diagnostics,
PerkinElmer. “We expect our newly released saliva-based collection
and asymptomatic test solution will play a large role in this
effort.”
PerkinElmer continues to work on the frontlines of improving
COVID-19 testing. The Company’s comprehensive SARS-CoV-2 offerings
span high throughput RNA extraction, RT-PCR, automation, ELISA,
chemiluminescence, time-resolved fluorescence and lateral flow
based 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 13,000 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 $2.9 billion in 2019,
serves customers in 190 countries, and is a component of the
S&P 500 index. Additional information is available through
1-877-PKI-NYSE, or at www.perkinelmer.com
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Chet Murray (781) 663-5728 chet.murray@perkinelmer.com