FDA approved Qiagen and DiaSorin's test for latent tuberculosis, the companies said Wednesday. The approval brings Qiagen's QuantiFERON-TB Gold Plus TB blood test to DiaSorin's Liaison immunoassay analyzers.
The U.S. approval of QFT-Plus for Liaison comes in the middle of a planned global rollout. Qiagen and DiaSorin received clearance to sell the test in Europe last year. Next year, the partners hope to make the test available in China, a country that sees an estimated 1 million new cases of TB every year.
News of the approval comes as Qiagen is in talks with "several" organizations it says are interested in acquiring the company.
Qiagen and DiaSorin began working together in 2017. The partners set out to develop tests based on Qiagen assay technologies for DiaSorin's Liaison analyzers, automated detection systems aimed at the hospital laboratory market. DiaSorin saw the collaboration as a way to expand the Liaison testing menu. For Qiagen, the deal is a way to get its tests to the users of the 8,000 Liaison systems DiaSorin has placed around the world.
Now, Qiagen and DiaSorin have secured FDA approval of a TB test. The approval covers a version of QuantiFERON-TB Gold Plus, also known as QFT-Plus, adapted for the automated workflow enabled by DiaSorin's Liaison. DiaSorin is based in Italy and Qiagen is headquartered in Germany.
QFT-Plus is designed to deliver faster results with less manual effort than is possible using the old tuberculin skin test for TB. Qiagen said bringing the test to Liaison will amplify those benefits.
"Combined with front-end automation options for liquid handling, the Liaison workflow for QFT-Plus delivers significant gains in turnaround time and efficiency," Thierry Bernard, interim CEO at Qiagen, said in a statement.
Qiagen is working toward the Chinese launch against a backdrop of uncertainty about its future. In mid-November, shares in Qiagen jumped after Bloomberg reported that Thermo Fisher was weighing an $8 billion takeover of the Dutch molecular test maker. Qiagen subsequently said it had received several non-binding indications of interest from potential buyers.
Reports that businesses are interested in buying Qiagen emerged shortly after the company disclosed a batch of bad news, including the departure of its CEO and a need to restructure in response to below-par financial results.