Qiagen, Ellume partner to develop QuantiFERON-TB Access for low-resource, high-disease burden regions

Qiagen announced Monday that it plans to develop a new version of its QuantiFERON-based tuberculosis (TB) test for low-resource regions with a high disease burden of TB. The company will undertake the work on the test, called QuantiFERON-TB Access (QFT Access), as part of a new partnership with Ellume. Financial terms of the deal were not disclosed.

Thierry Bernard, senior vice president of Qiagen's molecular diagnostics business area, remarked that QFT Access combines "the proven clinical insights of QuantiFERON-TB with Ellume's digital technologies to deliver cost-efficient results quickly and without need for a laboratory." Meanwhile, Masae Kawamura, senior director of TB medical and scientific affairs at Qiagen, suggested that the test "represents the biggest technology breakthrough in latent TB infection testing since the first FDA approval of QuantiFERON-TB in 2001."

According to Qiagen, QFT Access requires limited healthcare worker training, and allows assay processing and read-out with minimal hands-on time and no laboratory. The company added that the test can be completed with one patient visit and in about 24 hours, "unlike the skin test that requires two visits and requires a physician for assessment." The single-tube test is incubated for about 16 hours to 24 hours, after which results are determined in five minutes to 20 minutes on a small proprietary, single-use cartridge. "Results are displayed in real time on a compact hub, which can be operated using battery or USB power sources and independently of a computer," Qiagen said.

Qiagen and Ellume plan to start clinical trials of the new system this year with commercialisation expected to begin in 2020.

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