Diagnostics companies are railing against a new rule from the Centers for Medicare & Medicaid Services (CMS) that would allow the agency to pay the same as private insurance rates for clinical diagnostic laboratory tests, further tightening the strings on reimbursement.
Sequenom is riding the waves of change, appointing a new CEO days after the company struck a deal with UnitedHealthcare ($UNH) to offer its carrier screening tests to the insurer's 43 million covered lives. Read more >>
Liquid biopsy tests are gaining traction within the industry as a viable alternative to traditional screening methods for cancer. A recent report by financial services firm Cowen & Co. said annual sales for the tools could surpass $10 billion, and study results are also turning up positive data in favor of the tests. Read more >>
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The FDA is cracking down on Pathway Genomics for improperly marketing its liquid biopsy test, a couple of weeks after the company rolled out its product directly to consumers for the early detection of cancer. Read more >>
Illumina is joining forces with China's Amoy Diagnostics to create next-generation sequencing cancer tests for the Chinese clinical market, expanding its footprint in the country while strengthening its commitment to developing innovative technology for the disease.
Ilumina kicked off commercialization of its next-generation solid tumor sequencing panel to help researchers identify 15 commonly mutated genes in samples.
OraSure Technologies scored an additional $7.2 million from the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research Development Authority (BARDA) for its rapid Ebola test, building on a $10.4 million contract that it signed with BARDA in June 2015.
Pharma bigwigs Merck KGaA and Pfizer announced they are collaborating with Dako to develop a companion diagnostic to accompany their investigational immune checkpoint inhibiting candidate in the fight against cancer.
Quest Diagnostics has been working hard to diversify its offerings, beefing up its presence in diagnostics as it delivers on plans for growth. In its latest move, the company is teaming up with health IT outfit Inovalon to roll out a cloud-based analytics platform for healthcare providers.
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Chalk up another approval for Merck & Co.'s Keytruda. And it's a significant one, as it fights for market share against Bristol-Myers Squibb's Opdivo in the PD-1/PD-L1 field. The FDA Friday gave an accelerated approval for Keytruda for use on advanced non-small cell lung cancer (NSCLC). Opdivo is awaiting an accelerated approval.
GlaxoSmithKline is pinning its hopes on consumer health, a unit whose margins it expects to see at 20% by 2020. But just how does it expect to get there?