Sequenom is teaming up with Cypher Genomics to develop a noninvasive prenatal test using the company's advanced genome interpretation screening technology, eyeing a bigger share of an increasingly competitive market.
Medical device approvals continued at a steady clip in 2014 despite mounting pressure from lawmakers to roll out a more stringent review process. The FDA granted approvals for 33 innovative devices in 2014, up 43% over the number it OK'ed the year before, according to EP Vantage. FierceMedicalDevices covered device approvals from the first half of the year in an earlier report.
Roche's Ventana Medical Systems has submitted its companion diagnostic test for ALK1-positive lung cancer for FDA approval, inching the company closer to full regulatory approval for the product and helping it gain ground in a fiercely competitive cancer diagnostics market. Read more >>
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Prenatal screening tools are the trend du jour in the diagnostics industry, with companies such as Roche, Sequenom and Illumina cashing in on the market with innovative DNA technology that screens for fetus abnormalities. Read more >>
Quest Diagnostics inked a deal with the Centers for Disease Control and Prevention (CDC) to improve screening, diagnosis and treatment for four strains of viral hepatitis in the U.S., expanding on a previous collaboration and giving the company a boost as it continues to restructure and restore revenue growth.
Myriad Genetics is throwing in the towel in its fight to stop other companies from offering diagnostic tests that spot specific genes known to be associated with a higher risk of breast cancer.
HTG Molecular Diagnostics hinted around plans for a $60 million IPO in December, saying that it would use funds to boost R&D and commercialization for its high-volume genomic testing platform. Now, the Tucson, AZ-based company is adding more than $18 million to its pot as it continues to mull a public offering.
Roche got an FDA green light for its drug-resistant MRSA/SA test, chalking up another regulatory win and expanding the company's offerings on its cobas 4800 system.
Boston Children's Hospital spinoff Claritas Genomics has roped in $15 million in capital in a Series B round to help launch a new slate of next-generation sequencing-based tests for the diagnosis of pediatric genetic disorders. The Cambridge, MA-based company also plans to use the cash influx to continue to build its network of clinical pediatric disease experts.
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As the med tech industry homes in on next-generation devices for peripheral artery disease, medical experts are questioning the necessity of procedures to treat the disease, pointing to large Medicare payments made to physicians performing the operations.
Scientists in Florida have found a virus in ticks that is connected to hemorrhagic fever, which was thought to have disappeared globally more than 40 years ago.