Invitae has been working hard to expand its genetic testing menu, recently achieving its goal of passing the 500-gene mark. Now the company is homing in on its next objective, doubling its testing menu to deliver on its promise of surpassing 1,000 genes by 2016.
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. 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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Starting this week, FierceDiagnostics is going to be merging with its sister publication FierceMedicalDevices. We are not changing too much with FierceMedicalDevices, we will retain the name and brand but coverage will expand to include the diagnostics industry.
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.
Focus Diagnostics, a unit of Quest Diagnostics, announced that it has the FDA's 510(k) clearance for its Simplexa Flu A/B & RSV Direct Kit for 46 additional influenza A and B virus strains and 7 additional respiratory syncytial virus strains.
Illumina issued a profit warning due to poor sales of its NextSeq Series Desktop Sequencer as well as weakness in Europe and Japan, sending its stock tumbling 10% for the day. The company expects earnings per share to fall below consensus expectations, consistent with a 3% revenue shortfall.
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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Alongside the FDA, the Federal Trade Commission oversees the marketing and promotion of medical devices. FTC Consumer Education Specialist Aditi Jhaveri took to the agency's blog to warn consumers against purchasing unregulated devices that promote "do-it-yourself" projects, such as weight loss.
The federal Centers for Medicare and Medicaid Services employs a staff of 30 people to evaluate some 30,000 molecular tests, according to panelists speaking at discussion on improving the value proposition of diagnostics during the AdvaMed med tech conference.