CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery of its LIS and informatics specifically to enable
Tag: clinical testing
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
IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.”
That lyric almost describes what’s happened to Theranos Inc. since October 2015. Although some would argue that Theranos brought this misfortune upon itself, it
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation of LDTs. However, the full list
THE DARK REPORT is the only lab industry news source to recognize the significance of the lawsuit between the Cleveland Clinic Foundation and Cleveland HeartLab against a new lab company, True Health Diagnostics. It is the latest chapter in a string of questionable sales practices engaged in by defendants in the federal whistleblower lawsuit against Health
SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices.
One example is the disclosure by The Wall Street Journal in November that Theranos had an agreement with Safeway to put blood collection and
IT’S GETTING DOWN AND DIRTY in the cardiology testing sector of the lab industry. No less than the Cleveland Clinic Foundation, along with Cleveland HeartLab, have filed a patent infringement lawsuit against a start-up lab in Texas.
The defendant is True Health Diagnostics LLC, of Frisco, Texas. In an amended complaint filed November 30 in the
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal claimed that Theranos and Safeway are negotiating over this situation. If the two parties cannot
CEO SUMMARY: Events within the bankruptcy proceedings of Health Diagnostic Laboratory could be interpreted as setting the stage for the emergence of a laboratory company operated by executives-and marketed by a sales consultant-known to have had leadership roles in other lab companies accused by whistleblowers and the federal government of making illegal payments to induce physicians to refer lab tests to their respective lab companies. In that regard, some in the lab industry may consider this an example of history about to repeat itself.
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.