TAG:
FDA Clearance
December 01, 2008 “Intelligence: Late Breaking Lab News”
Having grown to over $1 billion in revenue, Inverness Medical Innovations, Inc. of Waltham, Massachusetts, is newest of the in vitro diagnostics (IVD) companies to achieve size and scale. One of its more interesting products is an in-home system that allows …
Momentum Continues for Digital Pathology
CEO SUMMARY: Last month, digital imaging in pathology gained additional momentum with the latest FDA clearance. Aperio Technologies, Inc., now has FDA clearance to market its slide scanning system for reading digital progesterone receptor (PR) slides on a computer monitor. Aperio plans to…
NY & Calif. Act to Stop Web Gene Testing Firms
CEO SUMMARY: Events in the past month indicate that a war is developing between Internet-based companies offering genetic tests to consumers and state and federal health regulators. New York state authorities have sent letters to at least 31 such companies in recent month…
Is Digital Path Imaging Ready for Prime Time?
CEO SUMMARY: Digital pathology imaging systems are finding uses in all phases of drug discovery (discovery, pre-clinical, clinical trials), as well as education, research, and clinical. One hurdle to widespread adoption of fully digitized, whole-slide pathology imaging systems is FDA clea…
Digitization of Pathology Is Making Steady Progress
CEO SUMMARY: Pathology digitization incorporates a greater scope of work-changing technologies than telepathology. It incorporates information technology, new diagnostic knowledge, and other engineering innovations to help pathologists move past glass and paper. Existing digital pathology…
FDA Approves New Test For Respiratory Viruses
CEO SUMMARY: Respiratory viruses are responsible for 75% of all visits to physicians and yet physicians struggle to identify whether an infection is viral or bacterial. Now there is a new molecular assay with FDA clearance that allows physicians to test for 12 common vira…
Inverness Buys Biosite, Has New Venture with P&G
CEO SUMMARY: On the same day that Inverness Medical Innovations announced that it would acquire Biosite, thus beating out Beckman Coulter in the bidding war for Biosite, Inverness also announced that it had entered into a joint venture with Procter & Gamble. Together, the two companie…
Bio-Rad Buys Ciphergen’s Proteomics Technology
PROTEOMICS IS EXPECTED TO BE ONE of the most active areas in molecular diagnostics and Bio-Rad Laboratories, Inc. has just staked a major claim to a promising proteomic technology. In a transaction announced on August 18, 2006, Bio-Rad will acquire the proprietary proteomics instrum…
“November 14, 2005 Intelligence: Late Breaking Lab News”
Home screening for colon cancer is about to commence on a large scale in the United Kingdom. Beginning in April 2006, two million people between the ages of 60 and 69 will be sent test kits every second year. Consumers will receive Fecal Occult Blood (FOB) test kits. They will collect their own speci…
“March 7, 2005 Intelligence: Late Breaking Lab News”
It was good news for the nine-year old boy with the rare brain tumor he named “Frankstein.” On midnight, Monday, February 14, 2005, the family received a telephone call from the surgeon who performed the biopsy on February 2, 2005. He confirmed that the biopsy was negative for cancer. What is int…
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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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