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association of molecular pathology
Using AI to Predict Outcomes in FDA LDT Lawsuits
By R. Lewis Dark | From the Volume XXXII, No. 1 – January 6, 2025 Issue
Given the popular sentiment that artificial intelligence (A…
September 19, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 13 – September 19, 2022 Issue
Déjà vu? Lawmakers in Congress question whether public health officials have done enough to stay ahead of monkeypox, including the availability of diagnostic tests. Concerns about such testing came up during a Sept. 14 hearing before the Senate’s Health, Education, Labor, and Pensions Committee. …
Congress May Soon Act on LDT, IVCT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
January 22, 2013 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XX No. 1 – January 22, 2013 Issue
Not-for-profit Boston Children’s Hospital will have majority interest in a new lab testing company. Claritas Genomics will be based in Waltham, Massachusetts, and will develop genetic and molecular diagnostic testing solutions. Life Technologies Corporation…
Unprecedented Growth Rates for Molecular Testing
By Joseph Burns | From the Volume XIX No. – October 8, 2012 Issue
CEO SUMMARY: There will be an expanding role for innovative clinical labs as healthcare moves forward on its path toward personalized medicine. However, to capitalize on this opportunity, pathology groups and clinical labs will need to beef up their information systems. They will also nee…
October 8, 2012 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XIX No. – October 8, 2012 Issue
Definiens AG, one of the major players in the fast-growing market for digital pathology, raised $12.8 million in additional capital funding. The company, based in Munich, Germany, manufacturers systems for digital image analysis. Definiens stated that the new funds will be used for â…
Lab Industry Unprepared For FDA Action on LDTs
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
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 …
February 15, 2010 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVII No. 3 – February 15, 2010 Issue
In response to the sky-rocketing expenses associated with genetic and molecular testing, health insurers are planning ways to control both utilization and the prices at which these tests are reimbursed. For example, during the past year, Humana began using DNA Direct …
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