TAG:
clia
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
May 15, 2017 Intelligence: Late Breaking Lab News
There is a new development in one of the whistleblower lawsuits filed against several lab companies that offered specialty cardiology tests. Earlier this month, the Department of Justice announced a settlement with Quest Diagnostics involving its acquisition of …
April 24, 2017 Intelligence: Late Breaking Lab News
Theranos, Inc., is again in the news. On April 17, the company disclosed a global settlement with the federal Centers for Medicare & Medicaid Services (CMS) to resolve “all outstanding legal and regulatory proceedings between CMS and Theranos.” The company sa…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…
February 21, 2017 Intelligence: Late Breaking Lab News
Theranos, Inc., was in the news again recently. On Feb. 16, The Wall Street Journal reported that Theranos had just $200 million in cash. The information came from a conference call the discredited lab testing company conducted with its investors. During the call, Theranos officials …
Health System Lab Is Genotyping To Identify Best Drugs for Patients
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …
Pharmacogenomic testing a success at South Dakota health system
This is an excerpt from a 2,700-word article in the January 30 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: One es…
NJ Lab Sues to Challenge Payers About Its Out-of-Network Status
ONE WAY THAT A CLINICAL LAB can fight back against insurers who refuse to pay lab test claims is to sue them. That’s exactly what Medical Diagnostic Laboratories of Hamilton, N.J. is doing! Not only has MDL filed lawsuits against two major health insurance companies, but in one la…
China Invests $9 Billion In Precision Medicine
CEO SUMMARY: In the 1960s, it was a race to be first in space between the United States and the Soviet Union. This decade, it’s a race to be first in genetic and precision medicine between the U.S. and China. To that end, the Chinese government has budgeted $9 billion as an investment t…
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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