molecular pathology Archives

TAG:

molecular pathology

Newer, Smaller Analyzers Will Bring Big Data to Labs

By Joseph Burns | From the Volume XXII No. 10 – July 13, 2015 Issue

CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…

New MoPath Lab Coalition Takes its Case to Congress

By Joseph Burns | From the Volume XX No. 8 – June 17, 2013 Issue

CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnosti…

Some Labs Report Faster Pay for Molecular, Genetic Tests

By Joseph Burns | From the Volume XXII NO. 8 – June 1, 2015 Issue

DURING RECENT MONTHS, some labs are reporting improvement in how their claims for certain molecular and genetic tests are being reimbursed. This is progress from the financial crises experienced during 2013 for many labs performing molecular and genetic tests….

Public Comment Started on FDA LDT Regulations

By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

Pathologist Raises Questions about Theranos’ Business Model

By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue

Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…

FDA Notifies Congress that It Will Regulate LDTs

By Joseph Burns | From the Volume XXI No. 11 – August 11, 2014 Issue

CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…

New Pricing Formula for Advanced Diagnostic Tests

By R. Lewis Dark | From the Volume XXI NO. 6 – April 28, 2014 Issue

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 …

Congress’ New SGR Law Has Mixed News for Labs

By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue

CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…

Maine’s Spectrum Medical Group Offers Multiple Specialties

By Joseph Burns | From the Volume XXI No. 4 – March 17, 2014 Issue

CEO SUMMARY: Pathologists looking for a viable future in a healthcare system marked by integration of clinical care and value-based reimbursement will be interested to learn about Spectrum Medical Group based in Portland, Maine. This 180-member multispecialist group includes 22 pathologis…

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.

See the full table of contents

How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Topics

Visit The Dark Library