TAG:
specialty lab
April 15, 2013 “Intelligence: Late Breaking Lab News”
Geisinger Health System broke ground last month on construction of a new $52 million medical laboratory facility. It will be 115,000 square feet and will be located at the site of the Geisinger Medical Center in Danville, Pennsylvania. LAB COMPANY COMPLET…
Low 2013 Molecular Rates May Bankrupt Some Labs
CEO SUMMARY: Many of the recently issued reimbursement rates for molecular diagnostic tests are inadequate and in fact are lower than the cost of running the tests, lab experts say. Smaller laboratories that specialize in developing and selling molecular tests could be forced to close. As…
Quest Sells OralDNA, HemoCue To Clear Its Decks for 2013
THIS WEEK, Quest Diagnostics Incorporated will issue its fourth quarter and full year 2012 financial report. In anticipation of this, the nation’s largest lab company has been cleaning out its closets, so to speak. With its new CEO finishing out his first eight months of service, …
Four California Labs Sue Quest and Three Insurers
CEO SUMMARY: Allegations of anticompetitive and monopolistic behaviors that violate state and federal laws are the basis of a private lawsuit filed by four independent clinical lab companies in California. The defendants are Quest Diagnostics Incorporated, Aetna, Blue Shield of California…
October 29, 2012 “Intelligence: Late Breaking Lab News”
OURLab and its parent company, Prost Data, Inc., of Nashville, Tennessee, entered into an agreement to be sold to Opko Health Inc., of Miami, Florida. The purchase price of $40 million will be paid as $9.4 million in cash and $30.6 million in stock. …
Time for Congress to Properly Fix CLIA PT Issue
THIS TIME, THE PROVERBIAL CAT MAY BE OUT OF THE BAG when it comes to long-standing dissatisfaction with how federal regulators interpret and enforce CLIA (Clinical Laboratory Improvement Amendments) regulations as they relate to inadvertent errors in the referral of proficiency tests (PT). For many …
Cleveland Clinic Lab Aims to Grow Reference Testing
CEO SUMMARY: In the national market for reference and esoteric testing, Cleveland Clinic Laboratories (CCL) is preparing to expand its presence. It has just moved into a $75 million state-of-the-art laboratory facility and wants to increase its outreach reference testing by four-fold with…
Why Pathologists Benefit from Growth of In-Office Path Labs
Dear Editor: Your article on the trend of office-based physicians building in-clinic anatomic pathology laboratories was fascinating, but in my opinion, it was off the mark. In the article, “AP Labs in Doc’s Clinics Now an Established Fact” (See TDR, September 6, 20…
Beckman Coulter and Genoptix Offer Themselves Up for Sale
FOR DIFFERENT REASONS, last month two large companies in the lab industry put themselves up for sale. Assuming that both companies are sold, one consequence may be further consolidation in both the in vitro diagnostics (IVD) manufacturing sector and the lab testing sector. It was on Decembe…
Many Questions About FDA Regulation of LDTs
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
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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