TAG:
molecular testing
Abbott Bets Hard on Cancer Diagnostics with New Deal
By Scott Wallask | From the Volume XXXII, No. 17 – December 8, 2025 Issue
Abbott Laboratories’ deal to acquire Exact Sciences for $23 billion emphasizes the value that the in vitro diagnostics (IVD) manufacturer puts on cancer testing. Clinical laboratories involved with oncology should monitor the progres…
What Private Equity Sees in Diagnostics
By Scott Wallask | From the Volume XXXII, No. 16 – November 17, 2025 Issue
CEO SUMMARY: Hologic’s acquisition by private equity firms Blackstone and TPG marks one of the year’s largest in vitro diagnostics transactions and a clear vote of confidence in the sector’s resilience. Industry analyst Bruce Carlson unpacks what the buyout …
Managing Denials and Appeals of Clinical Lab, Path Claims
By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue
CEO SUMMARY: Based on a study of denials and appeals involving about 20 million lab test claims, the team at XiFin Inc. presents here their findings. They also provide recommendations on steps labs can take to reduce denials and win a greater proportion of appeals. IN RECENT…
Despite COVID-19 Losses, IVD Executives Remain Upbeat
By Donna Pocius | From the Volume XXX, No. 8 – May 30, 2023 Issue
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
Payers Request More Claims Documentation
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Both anecdotal evidence from lab professionals and numbers-based data from XiFin point to a problem: More payers require clinical labs to produce more documentation that a test claim i…
Post-COVID: Repurposing Excess PCR Instruments
By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
November 4, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 14 – October 14, 2019 Issue
Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …
October 14, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 14 – October 14, 2019 Issue
Two interesting partners are working on a project to map the human immune system with the goal of creating a knowledge base that can be used to develop diagnostic tests. Microsoft and Adaptive Biotechnologies of Seattle are collaborating on this project. “Google c…
PGx Testing Labs Concerned by FDA’s Statements, Actions
By Mary Van Doren | From the Volume XXVI No. 12 – September 3, 2019 Issue
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
CURRENT ISSUE
Volume XXXII, No. 17 – December 8, 2025
Laboratory professionals are urged to make their voices heard in Congress as the end of a brief reprieve to PAMA cuts comes on January 30, 2026. Congress is said to be inclined to address reformation of PAMA now. Also, pathologists are slowly switching to cloud storage for their digital slides.
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