TAG:
genomics
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
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February 29, 2016 Intelligence: Late Breaking Lab News
Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…
February 8, 2016 Intelligence: Late Breaking Lab News
Microbiology’s most important reagent is undergoing a supply crunch and becoming more expensive. Agar production is being affected by two factors. One is the increased global demand for seaweed. The second are new restrictions on the trade of seaweed, intended to protect natural stocks of seaweed….
New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests
CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…
December 7, 2015 Intelligence: Late Breaking Lab News
Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…
Opportunities Ahead for Labs That Prepare
AT THE END OF EVERY YEAR, IT’S ALWAYS SMART BUSINESS FOR EVERY LAB to peer into the future specifically to identify the best clinical and financial opportunities. With the New Year just a few week…
November 16, 2015 Intelligence: Late Breaking Lab News
Roper Industries, the owner of Sunquest Information Systems, Inc., acquired two more lab informatics companies. On October 26, it announced a definitive agreement to purchase A…
NeoGenomics to Acquire Clarient for $275 Million
CEO SUMMARY: In a surprise move that further consolidates national anatomic pathology services, NeoGenomics will acquire Clarient Inc., from General Electric Healthcare. General Electric is getting cash, and preferred and common stock. The two companies announced plans to pursue integrate…
October 26, 2015 Intelligence: Late Breaking Lab News
Describing “nutritional chemistry and food safety as an exciting growth opportunity,” CEO David King of Laboratory Corporation of America announced his company’s recent acquisition of International Food Network and The National Food Laboratory. Terms of the deal were not announced. Some analys…
New Company Ready to Heat Up Slow Digital Pathology Market
CEO SUMMARY: There’s a new competitor in the digital pathology marketplace with ambitious plans to deliver a fully-integrated pathologist workflow solution. Inspirata, Inc., of Tampa, Florida, made its debut in March at an international pathology conference. In this exclusive i…
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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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