CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access
Tag: tests for cancer
CEO SUMMARY: Following an investigation of two lab companies providing direct access testing in New York State, the New York Attorney General entered into agreements with each lab company. Direct Laboratories, LLC, of Mandeville, Louisiana, agreed to cease offering DAT services in New York, pay restitution to patients, and pay a fine to the state.
CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new molecular and genetic tests at the rate of 10 per day! The company,
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer.
The collaboration calls for Sysmex, a major in vitro diagnostics (IVD) manufacturer with expertise in hematology testing, to work with LabCorp. Efforts will center around two assays developed at Sysmex Inostics, called OncoBEAM and Plasma-Sequencing.
CEO SUMMARY: It turns out that labs serving Tricare patients are going unpaid for certain LDTs, molecular, and genetic tests. The issue of nonpayment began in January 2013 when Tricare stopped paying for these tests that were billed under the new molecular CPT codes that replaced the previous stacking codes. Among the tests in question
ONE OF THE FEW PUBLIC STOCK OFFERINGS involving a lab testing company was completed last Wednesday. Exact Sciences, Inc., of Madison, Wisconsin sold $69 million worth of new shares to the public.
Exact Sciences has proprietary diagnostic technology that it describes as “for noninvasive, molecular screening technology for the detection of colorectal cancer.” During 2009, Exact
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover
CEO SUMMARY: Pathology supergroups in California and Tennessee have each announced major recapitalizations. Both groups will use some of the money to cash out retiring partners. The balance of the new capital will be used to expand their businesses. With so many baby boomer pathologists approaching retirement, these two transactions are likely to be studied
There’s early evidence that health benefit costs for 2005 may only increase by a single digit percentage. Hewitt Associates is gathering data from 160 large companies for its annual healthcare cost survey. It reports that an average increase of 13.7% appears likely, compared to a 17.5% increase in 2004. But when employers factor in the
CEO SUMMARY: Two unexpected things happened in IMPATH’s Chapter 11 bankruptcy action. First, it attracted a buyer willing to pay the premium price of $215 million for its assets. Second, the buyer was not another laboratory company. Rather, it is a new entrant into the oncology diagnostics marketplace. This raises interesting questions as to Genzyme’s