TAG:
molecular diagnostic
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
Could Health Insurers Be at War with Clinical Labs?
CEO SUMMARY: It may sound ridiculous to assert that the nation’s largest health insurers are now “waging war” against clinical labs. However, some very smart people in the profession of laboratory medicine are expressing this opinion. To support such a conclusion, they point to paye…
Pathology Consolidation Underway in Washington
CEO SUMMARY: Two regional pathology super-practices have emerged in Washington State. In each case, acquisitions and mergers are fueling the growth of the two large pathology groups. In Western Washington and the Seattle metro, CellNetix is the dominant pathology group, with 53 physicians…
New Pricing Formula for Advanced Diagnostic Tests
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
UCLA Pathologists to Open Joint Venture Lab in Shanghai
PATHOLOGISTS at the University of California Los Angeles Department of Pathology will participate in a unique commercial laboratory company that will be based in Shanghai, China. On April 8, UCLA announced a partnership agreement with Centre Testing International Corp….
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
Better Data Needed to Support Pathologists as Consultants
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
Labs, Path Groups Face Major Financial Issues
CEO SUMMARY: Are clinical labs and pathology groups ready for the end of fee-for-service reimbursement? That’s just one important question that will be answered at the upcoming Executive War College on Lab and Pathology Management that will take place in New Orleans on April 29-30. The …
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
CMS Cuts BRCA Price by 49% in Response to Competition
IN THE FINAL WEEKS OF 2013, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would reduce the price it pays for the BRCA genetic test by 49%, to $1,438, effective on January 1, 2014. For Myriad Genetics, Inc., this wa…
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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