FDA Approves T-Cell Select Test for Automated Tuberculosis Testing

The FDA has approved Oxford Immunotec’s T-Cell Select reagent kit, which will automate the workflow of the T-SPOT.TB test, a globally regulated ELISPOT IGRA that detects latent tuberculosis (TB) infection, for in-vitro diagnostic (IVD) in certified laboratories.¹

“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, PerkinElmer’s Oxford Immunotec division, in a press release. “This results in the highest quality of care for the most vulnerable patients across the United States.”¹

T-Cell Selectis a peripheral blood mononuclear cell (PBMC) isolation reagent that uses magnetic technology to separate, and in turn simplify, the preparation of PBMCs for lab testing.¹

Through automation, it works to strengthen blood sample logistics and create a longer lasting sample, which can be stored at room temperature for more than 2 days.¹ Additionally, the increased stability allows laboratories to have greater flexibility, which could include sample batching.¹

Patients with TB are immunocompromised, and as with other immunocompromised patients, they have lower levels of T cells, which makes it difficult to evaluate their PBMC sample.¹ The T-SPOT.TB test with the T-Cell Select reagent kit is unique because it is the only test of its kind to not include regulatory warnings for immunocompromised patients, according to Oxford Immunotec.¹

By 2026, the global IVD market is expected to generate $113.3 billion.² Increasing cases of chronic illness, an aging population, and increased automotive care instruments are suggested to be factors attributable for this increase.²

Government-funding for research drives the market for cell isolation, known as cell separation, which involves removing individual cells from samples taken from a biological resource, including tissue or blood. This funding can be used to study tissues in cancer and chronic illness, among other issues.³

Technological advancements are also believed to supplement the cell isolation market. Other recent advancements have been made by Serena Bright, who has created the first contrast-enhanced guided biopsy solution for breast cancer.³ Additional developments include those made by Beckman Coulter.³ This clinical diagnostics company launched a new Immunoglobulin M antibody test with 99.9% specificity against thousands of negative samples.³

The T-Cell Select reagent kit is available in Europe, South Korea, and China. Its FDA approval signals a growing acceptance across other worldwide markets, according to Oxford Immunotec.³

References

1. PerkinElmer. PerkinElmer’s Oxford Immunotec Receives U.S. FDA Approval for T-Cell Select to Automate Clinically Superior Tuberculosis Detection. Business Wire. September 22, 2022. Accessed on September 23, 2022. https://www.businesswire.com/news/home/20220922005528/en
2. Zacks Equity Research. PerkinElmer's (PKI) Reagent Kit Receives FDA Clearance. Nasdaq. September 23, 2022. Accessed on September 23, 2022. https://www.nasdaq.com/articles/perkinelmers-pki-reagent-kit-receives-fda-clearance
3. Verified Market Research. Cell Isolation Market is expected to generate a revenue of USD 20.50 Billion by 2028, Globally, at 15.70% CAGR: Verified Market Research®. Global Newswire. September 19, 2022. Accessed on September 23, 2022. https://www.globenewswire.com/news-release/2022/09/19/2518467/0/en/Cell-Isolation-Market-is-expected-to-generate-a-revenue-of-USD-20-50-Billion-by-2028-Globally-at-15-70-CAGR-Verified-Market-Research.html