PerkinElmer Receives CE Mark for Multi-analyte Respiratory Panel Including COVID-19
26.10.2020 15:00:00 EET | Business Wire | Press release
PerkinElmer, Inc. (NYSE: PKI) announced today that its PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel has received 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). This test is currently under review by the U.S. FDA for Emergency Use Authorization (EUA). The multi-analyte panel enables labs to detect and differentiate between SARS-CoV-2, influenza A viruses, influenza B viruses and respiratory syncytial virus (RSV) in a single test, which will be critical to manage the surge in test demand during the flu season as the targeted pathogens have some similar signs and symptoms.
Rather than running multiple tests on samples, the PKamp Respiratory SARS-CoV-2 RT-PCR Panel is designed to conserve resources by testing a single nasopharyngeal, oropharyngeal or nasal swab sample collected from individuals suspected of respiratory viral infection consistent with COVID-19, the flu and RSV. Building off the most sensitive SARS-CoV-2 test kit in the market according to the FDA’s reference panel comparative data, the multi-analyte panel is designed to be used with PerkinElmer’s automated viral nucleic extractor to detect smaller amounts of viral material in samples.
“In the next few months, it will be vital for health professionals to detect and differentiate between COVID-19, the common flu and RSV infection,” said Masoud Toloue, Ph.D., Vice President and General Manager, Diagnostics, PerkinElmer. “By offering an automated multi-analyte testing solution, we are equipping diagnostics labs with the right toolset to tackle the additional pressure the season may have on this pandemic.”
PerkinElmer continues to work with specialty and reference diagnostic labs, clinics, hospitals, pharmaceutical and biopharmaceutical labs, academia, and governmental and research institutes to battle the pandemic. PerkinElmer’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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201026005308/en/
Contact information
Media Relations:
Chet Murray
(781) 663-5719
chet.murray@perkinlelmer.com
Investor Relations:
Bryan Kipp
(781) 663-5583
bryan.kipp@perkinelmer.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Following Oral Presentation of Phase I Data at AACR 2026, Debiopharm Announces FDA Fast Track Designation for Lunresertib in Combination With Zedoresertib for Genomic-Defined Platinum-Resistant Ovarian Cancer20.4.2026 15:30:00 EEST | Press release
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123). The designation is for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and fill an unmet medical need. Programs granted Fast Track designation benefit from more frequent communication with the FDA and, if relevant criteria are met, may be eligible for Priority Review and Accelerated Approval of a New Drug Application (NDA). Momentum Following AACR O
Following Oral Presentation of Phase I Data at AACR 2026, Debiopharm Announces FDA Fast Track Designation for Lunresertib in Combination With Zedoresertib for Genomic-Defined Platinum-Resistant Ovarian Cancer20.4.2026 15:30:00 EEST | Press release
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123). The designation is for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and fill an unmet medical need. Programs granted Fast Track designation benefit from more frequent communication with the FDA and, if relevant criteria are met, may be eligible for Priority Review and Accelerated Approval of a New Drug Application (NDA). Momentum Following AACR O
Data4Industry-X Empowers Industrial Organizations in Meeting Digital Product Passport Requirements20.4.2026 15:17:00 EEST | Press release
Hannover Messe - Data4Industry-X, the trusted industry data space solution, builds its momentum by accelerating Digital Product Passport (DPP) compliance with trusted, secure and traceable data exchange at scale, as demonstrated at Hannover Messe April 20-24, 2026 . As theDigital Product Passport becomes a regulatory reality for manufacturing organizations, the ability to exchange data in a trusted, secure and traceable environment across the entire supply chain, in compliance with data regulations such as the Data Act, has become critical. Actively contributing to the International Manufacturing-X Council showcase, driven by LNI 4.0 association involving 16 countries, Data4Industry-X, a decentralized environment, demonstrates the use case of the DPP on the battery’s State of Health, and how the battery current capacity and performance information are continuously updating the DPP and seamlessly exchanged with DPP applications. Data4Industry-X builds on European standards such as the G
Data4Industry-X Empowers Industrial Organizations in Meeting Digital Product Passport Requirements20.4.2026 15:17:00 EEST | Press release
Hannover Messe - Data4Industry-X, the trusted industry data space solution, builds its momentum by accelerating Digital Product Passport (DPP) compliance with trusted, secure and traceable data exchange at scale, as demonstrated at Hannover Messe April 20-24, 2026 . As theDigital Product Passport becomes a regulatory reality for manufacturing organizations, the ability to exchange data in a trusted, secure and traceable environment across the entire supply chain, in compliance with data regulations such as the Data Act, has become critical. Actively contributing to the International Manufacturing-X Council showcase, driven by LNI 4.0 association involving 16 countries, Data4Industry-X, a decentralized environment, demonstrates the use case of the DPP on the battery’s State of Health, and how the battery current capacity and performance information are continuously updating the DPP and seamlessly exchanged with DPP applications. Data4Industry-X builds on European standards such as the G
Saildrone Unveils Spectre, a New Class of High-Speed Unmanned Surface Vessel for Naval Operations20.4.2026 15:00:00 EEST | Press release
Saildrone, the world leader and most experienced operator of unmanned surface vehicles (USVs), today released the design of the Saildrone Spectre, the culmination of two years of intense design work, leveraging over 10 years of operational USV experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420620393/en/ Two Saildrone Spectre variants are built around different mission needs: Spectre Silent Endurance (right) uses wing assist for extreme endurance and silent propulsion. Spectre Stealth Strike (left) meets all mUSV requirements. At 52 meters (170 feet) long, weighing 250 tonnes, and capable of up to 30 knots, Spectre is the largest, fastest, and most capable Saildrone platform to date. Spectre is optimized for anti-submarine warfare (ASW) operations, a mission set that demands extreme endurance and an ultra-quiet acoustic signature. Spectre achieves this by leveraging the proven endurance, reliability, and silent
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom