PerkinElmer's Oxford Immunotec receives US FDA clearance for T-Cell Select to automate clinically superior tuberculosis detection

PerkinElmer's Oxford Immunotec receives US FDA clearance for T-Cell Select to automate clinically superior tuberculosis detection

PerkinElmer's (NYSE: PKI) Oxford Immunotec today announced that the U.S. Food and Drug Administration (FDA) has approved the use of T-Cell Select™ reagent kit for the automation of its T-SPOT®.TB test workflow for use in in vitro diagnostics (IVD) by certified laboratories.

The T cell selection The reagent kit enables a more automated workflow, reducing laboratory staff time and reducing overall costs. The increasing use of automation also improves blood sample logistics, as a standard blood collection tube can be stored at room temperature for up to 54 hours without complex blood collection procedures. Extended blood sample stability allows for easy centralization of sample processing, expanding access to the T-SPOT.TB test and providing laboratories more flexibility with the ability to stack samples.

T-Cell Select is a peripheral blood mononuclear cell (PBMC) isolation reagent that utilizes positive selection of PBMCs with bead-based magnetic cell separation to automate and simplify the preparation of cells for cell separation T-SPOT.TB test, a globally regulated ELISPOT IGRA for the detection of latent TB infections. The T-SPOT.TB test with the T-Cell Select reagent kit is the only automated IGRA-TB test without regulatory (label) warnings for immunocompromised patients, who often have lower T cell values ​​available for evaluation.

Automation closes the gap between ELISPOT and ELISA laboratory workflows and enables more laboratories to offer the clinically superior T-SPOT.TB test to more physicians.”

Phill Keefe, CEO of PerkinElmer's Oxford Immunotec division.

“This results in the highest quality of care for the most vulnerable patients in the United States.”

The T-Cell Select reagent kit is available throughout Europe where CE marking is accepted, in South Korea by the Ministry of Food and Drug Safety, and in China by the National Medical Products Administration (NMPA), and is rapidly becoming available in additional markets around the world.

About PerkinElmer

PerkinElmer is a leading global provider of end-to-end solutions that help scientists, researchers and clinicians better diagnose diseases, discover new and more personalized medicines, monitor the safety and quality of our food, and drive excellence in environmental and applied analytics. With 85 years of experience advancing science and a mission to innovate for a healthier world, our dedicated team of more than 16,000 employees works closely with business, government, academic and healthcare customers to deliver reagents, tests, instrumentation, automation, informatics and strategy services that accelerate workflows, deliver actionable insights and support improved decision-making. We are also strongly committed to good corporate social responsibility through our dynamic ESG and sustainability programs. The company reported sales of approximately $5 billion in 2021, serves customers in 190 countries and is a component of the S&P 500 index. For more information, see www.perkinelmer.com. Follow PerkinElmer on LinkedIn, Twitter, Facebook, Instagram And Youtube.

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