Bio-Techne expects the acquisition will provide it with a basis to build out its IVD presence, given Asuragen's diagnostic tests and regulatory expertise.
The firm said it has developed a POC test that uses a biomarker for HPV16, which is responsible for more than 90 percent of all HPV-related head and neck tumors.
According to the company, the test is 98 percent sensitive and 100 percent specific for detecting SARS-CoV-2, in both symptomatic and asymptomatic individuals.
The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.
FDA has signaled via public comments that it is flexible on test performance specs, but firms remain wary of falling short of official agency requirements.
Danaher’s guidance of double-digit top-line growth for 2021 provides upside opportunities that depend mostly on the success of vaccine rollouts, Barclays said.
