TAG:
molecular assay
Preparing for New Lab Role In Personalized Medicine
CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…
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…
“Liked the Product–Bought the Company,” BD Acquires HandyLab and Jaguar System
IT WAS 1979 WHEN VICTOR KIAM jump-started sales of Remington electric razors with his classic, witty ad campaign, “I liked the product so much, I bought the company!” Now the same thing is happening with a benchtop-sized automated system for molecular PCR testing. In this case, it is Bec…
The $1,000 Genome and Laboratory Testing
IT WAS 1953 WHEN JAMES D. WATSON AND FRANCIS CRICK, working from X-ray data collected by Rosalind Franklin, described the double helix structure of the DNA molecule. That discovery inspired scientists to begin investigating the genetic basis of life. In the 56 years since Watson and Crick published …
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…
Influenza A/H1N1 Outbreak Offers Lessons for Labs
CEO SUMMARY: As influenza A/H1N1 spread, clinical labs nationwide learned that they did not have the capacity to test for an outbreak of flu that generated a 10-fold increase in sample volume. To move the samples through the system, many clinical labs ran extra shifts and ran sho…
New Report: POC Market Will Grow 30% by 2013
CEO SUMMARY: It will be no surprise to lab directors and pathologists that Kalorama Information, in its latest report on point-of-care (POC) testing, estimates that glucose testing comprises 67% of this market segment. What is notable is Kalorama’s prediction that worldwide POC…
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…
2008’s Top Ten Lab Stories Lacked Disruptive Impact
CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…
Genome Sequencing Promises to be Disruptive
EVERYONE SHOULD CAREFULLY READ OUR LEAD STORY ON THE FACING PAGE. Titled “Rapid Gene Sequencing Predicted by Mid-2009,” it is a revealing look at the declaration of California-based Complete Genetics that, in less than eight months, it will begin delivering full human genome sequ…
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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