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companion diagnostic
August 23, 2010 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVII No. 12 – August 23, 2010 Issue
With the goal of developing biomarkers useful in diagnosing a variety of cancers, Pathwork Diagnostics, Inc., and Novartis AG announced a research partnership on July 30. It is an early example of a collaboration between a diagnostics company and a pharmaceutical com…
Oncologists Cut Into Pathologists’ Revenue Pie
By R. Lewis Dark | From the Volume XVII No. 4 – March 8, 2010 Issue
EVENTS NOW UNFOLDING IN DALLAS, TEXAS, SIGNAL A DIFFERENT DIRECTION for pathology and clinical laboratory testing. As you will read on pages 3-9, in May, just weeks from now, a new laboratory company, funded with $40 million from an unlikely combination of four partners, is about to become operationa…
Preparing for New Lab Role In Personalized Medicine
By Robert Michel | From the Volume XVII No. 4 – March 8, 2010 Issue
CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…
Two New Pathology Models Will Soon Be Tried in Dallas
By Robert Michel | From the Volume XVII No. 4 – March 8, 2010 Issue
CEO SUMMARY: There are notable aspects to how and why four unlikely partners are banding together to invest $40 million and create the nation’s newest reference and esoteric testing laboratory. It was the pathologists at Baylor University Hospital in Dallas, Texas, who originated the vi…
Baylor Pathologists Form Lab with US Oncology
By Robert Michel | From the Volume XVII No. 4 – March 8, 2010 Issue
CEO SUMMARY: In Dallas, Pathologists Bio-Medical Laboratories is part of a new laboratory partnership that includes Baylor Health Care System, Texas Oncology, and US Oncology. The four partners ponied up a total of $40 million in cash and debt to build a state-of-the art laboratory in a 1…
Pathology, Inc. Sells Equity to Raise Capital
By Robert Michel | From the Volume XVII No. 2 – January 25, 2010 Issue
CEO SUMMARY: In looking how to propel its business to the next level, the partners at Pathology, Inc., opted not to sell their pathology group practice. Instead, they chose to raise capital by selling equity in their company to a group of investors. In this exclusive interview, executives…
Two Big Pathology Groups Tap Investors for Capital
By Robert Michel | From the Volume XVII No. 2 – January 25, 2010 Issue
CEO SUMMARY: Pathology supergroups in California and Tennessee have each announced major recapitalizations. Both groups will use some of the money to cash out retiring partners. The balance of the new capital will be used to expand their businesses. With so many baby boomer pathologists a…
2009’s Top Ten Lab Stories Reflect Some Good, Bad
By Robert Michel | From the Volume XVI No. 17 – December 14, 2009 Issue
CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…
GSK and Abbott Team up For Companion Diagnostic
By Robert Michel | From the Volume XVI No. 14 – October 12, 2009 Issue
CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…
New Lab Player Launches In Breast Cancer Market
By Robert Michel | From the Volume XVI No. 11 – August 10, 2009 Issue
CEO SUMMARY: Having opened its CLIA-licensed laboratory in Huntington Beach, California, Agendia, Inc., becomes the newest competitor to enter the market for breast cancer testing. Its proprietary assay looks at 70 genes to assess the risk of recurrence. The company expects to co…
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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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