San Diego-based diagnostics maker Quidel has seen its stock gain 6% to $29.50 since December 30, when it announced that it received FDA clearance for its AmpliVue Group B Strep (GBS) assay, a handheld test that health workers can use to rapidly detect the disease. Now some analysts are predicting the company could see even more of a surge on strong demand for its rapid flu tests.
California's Quidel picked up FDA clearances for two infectious disease tests that run on Life Technologies' diagnostics platform, and the two companies are partnering up to spread the assays around the globe.
The deal is done. Diagnostic test maker Quidel now officially owns BioHelix, a Beverly, MA maker of nucleic acid technology for molecular diagnostic tests. Quidel is paying $10 million in cash up front, plus more money depending on a number of development and sales milestones.
Quidel has its latest molecular diagnostic test approval in hand, this time a CE mark for a blood test that screens for herpes plus a virus that causes chicken pox and shingles.
Quidel won a coveted 510(k) clearance from the FDA for a new hand-held molecular diagnostic test to detect DNA for Clostridium difficile bacteria.
Quidel ($QDEL) has received the CE mark for its first molecular diagnostic test, the Influenza A+B real-time RT-PCR assay. The CE mark allows for the launch of the open box molecular platform in