TAG:
genetic tests
Lawyers Provide Insights About Top Legal Concerns
CEO SUMMARY: After conducting the first-ever survey of the most important legal, compliance and managed care concerns for clinical labs and pathology groups, THE DARK REPORT asked leading lab industry attorneys who participated in the survey to say a few words about these topics….
March 21, 2011 “Intelligence: Late Breaking Lab News”
Regulation of genetic tests by the Food and Drug Administration (FDA) continues to move forward. Earlier this month, an FDA advisory panel conducted hearings on this subject. The Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee discussed several asp…
Solstas Lab Partners, DNA Direct, Pathology, Inc., Slone Partners, PAML
SPECTRUM-CARILION NOW WILL BE CALLED SOLSTAS LAB PARTNERS IT IS THE NEXT STEP IN THE INTEGRATION of Spectrum Laboratory Network and Carilion Laboratories. Effective February 1, 2011, their combined businesses will use the name Solsta…
Sunquest’s LIS Product First To Earn Certification from CCHIT
IF THERE WAS A RACE TO BE FIRST TO OFFER a laboratory information system (LIS) product that is certified to be compliant as an (EHR) electronic health record module by CCHIT, then Sunquest Information Systems, Inc., has attained that achievement. On January 21, 2011, the Cer…
More Reimbursement Threats for Lab Testing
WE ARE NOW WELL INTO THE FIRST MONTH OF 2011 and already there are plenty of signs that reimbursement for both clinical laboratory testing and anatomic pathology testing will come under siege from a variety of sources this year. Take, for example, the rather rapid action by the Centers for M…
Whole Genome Sequencing: Is It Ready for Prime Time?
CEO Summary: Pathologists at Beth Israel Deaconess Medical Center in Boston, Massachusetts, in a collaboration with GenomeQuest, Inc., will produce whole human genome sequences of patient tumors and other specimens. These whole genome sequences will be studied to learn what diagn…
Early Warning on LDTs and Pre-Authorization
ANY PATHOLOGIST OR LABORATORY MANAGER who considers this to be a quiet time in the laboratory testing industry is setting themselves up for a rude awakening in the not too distant future. Several stories in this issue are written specifically to call attention to major developments in the profession …
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 …
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…
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
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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