TAG:
diagnostic assays
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
Health Insurers See Big Increase in Lab Utilization
CEO SUMMARY: In a recent public workshop, managed care executives revealed that the annual cost of outpatient laboratory testing is increasing at twice the rate of all other medical services. One big driver in the increased spending on lab testing is increased utilization…
Medicare Taken to Task about Molecular Test Pricing Method
EDITOR’S NOTE: Submitted by Lâle White, CEO of XIFIN, Inc., of Carlsbad, California, this letter describes the problems caused by the Medicare program’s failure, as of January 1, 2013, to be ready to process and reimburse lab test claims for more than 100 new mo…
March 25, 2013 “Intelligence: Late Breaking Lab News”
Last month, Dignity Health acknowledged that it is engaged in negotiations to sell its lab outreach business that is based in Stockton, California. The lab outreach program is known as HealthCare Clinical Laboratories and is associated with 294-bed St. Joseph…
Ascend Clinical Acquires PathCentral Lab Business
CEO SUMMARY: Ascend Clinical and PathCentral see an opportunity to provide sophisticated services to community pathology groups. Ascend Clinical will expand the molecular diagnostic and gene sequencing business it is purchasing from PathCentral. PathCentral will concentrate on marketing i…
November 19, 2012 “Intelligence: Late Breaking Lab News”
Only one clinical lab industry vendor made the inaugural list of the Modern Healthcare’s fastest- growing health companies. It was Sysmex America, of Mundelein, Illinois. Sysmex ranked number 26 on a list of 40 healthcare companies. Modern Healthcare reported that…
2011’s Top 10 Lab Stories Point to a Busy 2012
CEO SUMMARY: Given the specific news stories that make up THE DARK REPORT’S list of the “Top Ten Lab Stories for 2011,” it might be said that 2011 was a rather quiet year overshadowed by anticipation of the coming reforms mandated by the Accountable Care Act of 2010. For the clinica…
“Primary-Care Pathology” One Goal at Beth Israel
CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annota…
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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