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CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab industry that finds itself struggling just …
Much Disruption for Labs In 2016’s Top 10 Stories Read More »
BY NOW, MANY LAB PROFESSIONALS KNOW CMS sent a letter to Theranos in early July that imposed multiple CLIA sanctions on the beleaguered laboratory company. In this issue, THE DARK REPORT provides informed analysis, along with its expert prediction that Theranos may be preparing to abandon its clinical lab testing and direct-to-consumer strategies in favor of a new strategy involving in vitro diagnostics (IVD). Also in the issue is an exclusive interview with two attorneys recognized for their expertise in clinical lab laws and compliance, who note that the Theranos letter differs markedly from other lab sanction letters they have seen − and seems to give Theranos some surprising options.
IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved one’s physician had …
Do Regulators Really Protect Patients, Consumers? Read More »
HOW MANY OF YOU SAW THE NEWS STORY PUBLISHED LAST MONTH by The Wall Street Journal with the headline, “Is Lab Testing the ‘Wild West’ of Medicine?” It is the latest in a series of news stories about issues and questions involving the accuracy and quality of clinical laboratory tests delivered to patients daily here …
NY Times Asks: ‘Is Lab Testing the Wild West?’ Read More »
DID THERANOS dismiss its CLIA lab director? As always, rumor runs rampant with the ever-secretive, self-proclaimed lab industry disruptor, and questions remain about the possible departure of this individual – without a new job in sight. Meanwhile, in the search for ways to add more value to lab testing services, pathologists and lab administrators are considering organizing diagnostic management teams within their hospitals, with specific lessons that can be learned by all their colleagues.
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry since passage of the CLIA 1988 …
Top 10 2014 Biggest News Stories Read More »
CEO SUMMARY: A disruptive innovation is one that shakes up an entire market or industry. By adding clinical lab testing to its health services offerings in more than 8,100 stores nationwide, Walgreens could disrupt the status quo in the clinical lab industry. Walgreens says its lab partner will offer testing at prices that are less …
Walgreens To Go National with Lab Tests in Stores Read More »
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding growth at this lab company. Here is an inside look at six factors which …
Why One Molecular Diagnostics Company Closed Its Doors Read More »
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