PerkinElmer’s Oxford Immunotec Receives U.S. FDA Approval for T-Cell Select to Automate Clinically Superior Tuberculosis Detection

Rhea-AI Summary

PerkinElmer has announced FDA approval for the T-Cell Select™ reagent kit to automate the T-SPOT.TB test, enhancing lab workflow efficiency. This kit facilitates a standardized blood sample process, minimizing complex practices and allowing for room temperature storage for up to 54 hours. It is notable as the first automated IGRA TB test without regulatory warnings for immunocompromised patients. The product is set to expand access to superior latent TB testing across laboratories in the U.S. and beyond.

Positive

• FDA approval of T-Cell Select reagent kit enhances automation in T-SPOT.TB testing.
• The reagent allows labs to reduce hands-on time and costs while improving sample logistics.
• First automated IGRA TB test without regulatory warnings for immunocompromised patients.

Negative

• None.

T-Cell Select reagent kit simplifies the T-SPOT.TB test laboratory workflow through automation expanding access to the most sensitive latent TB test on the market

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

The T-Cell Select reagent kit allows for a more automated workflow, designed to reduce hands-on time for lab personnel and lower overall costs. The increased use of automation also improves blood sample logistics, as it allows for a standard blood collection tube which can be stored at room temperature for up to 54 hours with no complex phlebotomy practices. The extended blood sample stability enables easy centralization of sample processing, which expands access to the T-SPOT.TB test and gives laboratories more flexibility with the potential for sample batching.

T-Cell Select is a peripheral blood mononuclear cell (PBMC) isolation reagent that uses positive selection of PBMCs with magnetic bead-based cell separation to automate and simplify the preparation of cells for the T-SPOT.TB test, a globally regulated ELISPOT IGRA for detecting latent TB infection. 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 levels of T cells available to evaluate.

“Automation closes the gap between ELISPOT and ELISA laboratory workflows, enabling more laboratories to offer the clinically superior T-SPOT.TB test to more physicians,” said Phill Keefe, chief executive officer of PerkinElmer’s Oxford Immunotec division. “This results in the highest quality of care for the most vulnerable patients across the United States.”

The T-Cell Select reagent kit is available throughout Europe where CE marking is accepted, South Korea by the Ministry of Food and Drug Safety, China by the National Medical Products Administration (NMPA) and is quickly becoming available in more 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 disease, discover new and more personalized drugs, monitor the safety and quality of our food, and drive environmental and applied analysis excellence. With an 85-year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team of more than 16,000 collaborates closely with commercial, government, academic and healthcare customers to deliver reagents, assays, instruments, automation, informatics and strategic services that accelerate workflows, deliver actionable insights and support improved decision making. We are also deeply committed to good corporate citizenship through our dynamic ESG and sustainability programs. The Company reported revenues of approximately $5 billion in 2021, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available at www.perkinelmer.com. Follow PerkinElmer on LinkedIn, Twitter, Facebook, Instagram, and YouTube.

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Investor Relations:

Steve Willoughby

(781) 663-5677

steve.willoughby@perkinelmer.com

Media Relations:

Chet Murray

(781) 663-5719

chet.murray@perkinelmer.com

Source: PerkinElmer

FAQ

What is the T-Cell Select reagent kit approved by the FDA for?

The T-Cell Select reagent kit automates the T-SPOT.TB test workflow for in vitro diagnostics.

How does the T-Cell Select reagent kit improve laboratory workflows?

It reduces hands-on time for lab personnel, lowers costs, and improves blood sample logistics.

What distinguishes the T-SPOT.TB test with T-Cell Select from other tests?

It is the only automated IGRA TB test that does not have regulatory warnings for immunocompromised patients.

In which markets is the T-Cell Select reagent kit available?

It is available in the U.S., Europe, South Korea, and China, with plans for expansion in more markets.