FDA Approves T-Cell Select Test for Automated Tuberculosis Testing

A new cell isolation kit was approved by the FDA to decrease the amount of time needed in a lab and lower overall costs for testing tuberculosis.

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