TAG:
molecular pathology
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 …
February 15, 2010 “Intelligence: Late Breaking Lab News”
In response to the sky-rocketing expenses associated with genetic and molecular testing, health insurers are planning ways to control both utilization and the prices at which these tests are reimbursed. For example, during the past year, Humana began using DNA Direct …
New Lab Player Launches In Breast Cancer Market
CEO SUMMARY: Having opened its CLIA-licensed laboratory in Huntington Beach, California, Agendia, Inc., becomes the newest competitor to enter the market for breast cancer testing. Its proprietary assay looks at 70 genes to assess the risk of recurrence. The company expects to co…
Lab M&A Deals in June Show Market Direction
CEO SUMMARY: Despite a dismal economy, the month of June spawned two interesting merger/acquisition transactions in the lab testing industry. In one case, a blood brother gobbled up a specialty diagnostics company. In another transaction, two cross-town neighbors in Kansas City m…
Multi-Modality Diagnosis Heading for Lab Medicine
CEO Summary: At the upcoming Molecular Summit in Philadelphia on February 10-11, 2009, pathologists, molecular imaging experts, and informaticians will share the latest developments on the integration of in vivo (imaging) and in vitro (pathology) diagnost…
Hospital Labs Have New Options for Molecular Dx
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier …
Powerful Trends Reshaping Anatomic Path Profession
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
Unprecedented Activity Across Lab Medicine
CEO SUMMARY: Laboratory medicine is now considered one of the best opportunities to profit as the demand for healthcare services skyrockets, both in the United States and throughout the world. This is why a flood of investment capital is washing into the laboratory industry. Loaded with c…
Global Laboratory Trends Dominated by Rising Costs and Labor Shortage
“The Web has transformed many industries and it’s clearly affected our industry. This trend will help raise the bar in quality and overall performance among laboratories and manufacturers.” —Jim Reid-Anderson Chairman, President, and CEO of Dade Behring…
Joint Venture Launches Molecular Pathology Lab
CEO SUMMARY: As genomic medicine advances, researchers into various diseases quickly recognize the need to incorporate molecular pathologists onto their teams. In Grand Rapids, Michigan, a large integrated health system and a private research institute have come together to jointly fund a…
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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