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 >>
Cancer Genetics got approval from a U.S. bankruptcy court in Delaware to purchase Response Genetics, almost two months after the company emerged as the highest bidder in an auction sale of Response's long-beleaguered business.
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.
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Axovant Sciences, rolling the dice on a once-failed Alzheimer's disease treatment, kicked off its big Phase III trial, a make-or-break effort that could spawn a blockbuster drug or liquidate the company's value.
Drug sourcing and distribution behemoth AmerisourceBergen figures that the best way to source compounded drugs for its hospital clients is to manufacture them itself. To do that, company will shell out more than $2.5 billion to buy one of the largest sterile drug compounders in the U.S.