PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals
20.11.2020 10:00:00 EET | Business Wire | Press release
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
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/20201119006186/en/
Contact information
Chet Murray
(781) 663-5728
chet.murray@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
NTT DOCOMO BUSINESS and Chile’s State-owned Copper Company CODELCO Launch a Study and Proof of Concept Aimed at Improving the Efficiency of Remote Copper Mine Operations Using IOWN ® APN6.8.2026 07:30:00 EEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) has launched a study and proof of concept jointly with Corporación Nacional del Cobre de Chile (CODELCO) to progress remote operations at CODELCO’s copper mines using an IOWN® All-Photonics Network (APN).1 This initiative is part of a research project commissioned by Japan’s Ministry of Internal Affairs and Communications.2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806845222/en/ Conceptual Diagram of the Demonstration To address operational challenges faced by CODELCO’s copper mines, the initiative will connect a copper mine and a remote operations center—approximately 1,500 km apart—via an IOWN APN. It will assess the feasibility of remotely operating heavy machinery using high-capacity, low-latency communication links, enhancing monitoring operations through high-definition video, and implementing a remote operations model. 1. Background Chile is o
FPT Named an OpenAI Select Partner6.8.2026 03:00:00 EEST | Press release
Global IT corporation FPT today announced that it has been named an OpenAI Select Partner within the OpenAI Partner Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805503787/en/ FPT Named an OpenAI Select Partner The OpenAI Partner Network is a global program for partners to build, sell, and deliver AI solutions with OpenAI. It brings together partners with deep industry expertise, delivery capabilities, and customer relationships while equipping them with resources, enablement, and support to help enterprises adopt OpenAI frontier models and products and turn them into measurable impact. As an OpenAI Select Partner, FPT will continue working with OpenAI to help organizations build, deploy, and scale AI solutions responsibly and effectively. This work will help organizations get more useful work from every token and stronger performance per dollar with GPT‑5.6, while using ChatGPT Work to turn ambitious goals into
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 01:10:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and howpeople feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.” NT1 is a rare, chronic neurological disease d
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 23:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
Clinilabs Announces Medical Leadership Appointments5.8.2026 17:05:00 EEST | Press release
Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership, and operational excellence with a track record of execution from first-in-human studies through regulatory
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