TAG:
in vitro diagnostic
FDA Clears Digital Path for Primary Diagnosis
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those pr…
Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis
This is an excerpt from a 1,400-word article in the April 24, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …
June 13, 2016 Intelligence: Late Breaking Lab News
Life insurers are adopting healthcare big data as part of their underwriting process and clinical laboratory test data has an important role. Quest Diagnostics Incorporated participates in this business line. Huffington Post recently published a story on this topic and ident…
New Lab Industry Trends Require Responses by Labs
CEO SUMMARY: One stark difference between the presentations delivered at last year’s Executive War College and this year’s presentations in New Orleans last week was near-unanimous recognition that the era of fee-for-service payment is soon to end! Speaker after speaker urged the…
Quality Assurance Regs to Tighten for UK Labs
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
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…
More IVD Consolidation as Danaher Acquires Iris
CEO SUMMARY: Danaher Corporation continues to fuel growth by continually acquiring in vitro diagnostics (IVD) companies. Its latest purchase is Iris International, which manufactures automated urine microscopy systems. Danaher also has $5 billion available that it could spend in the next …
Office-Based Physicians Want In-Clinic Laboratories
CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…
March 21, 2011 “Intelligence: Late Breaking Lab News”
Regulation of genetic tests by the Food and Drug Administration (FDA) continues to move forward. Earlier this month, an FDA advisory panel conducted hearings on this subject. The Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee discussed several asp…
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 …
CURRENT ISSUE
Volume XXVII No. 7 – May 11, 2020
LABS CAN REST EASIER knowing that the initial flood of unvalidated faulty or fraudulent serological COVID-19 tests is being halted now that the FDA has done an about-face on its policies. And THE DARK REPORT offers behind-the-scenes insights into the COVID-19 Testing Project which used a multidisciplinary effort to analyze and compare the performance of 12 of these tests. In other good news, THE DARK REPORT reports on a potential new revenue source for cash-strapped labs.
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