News Flash! New York Times Hits Quest Diagnostics for Erroneous Vitamin D Results!

Just days after The Dark Report and Dark Daily alerted the laboratory industry to systemic problems with “home brew” mass spectrometry Vitamin D testing at Quest Diagnostics Incorporated (NYSE:DGX) during a period starting in early 2007 and lasting into mid-2008, the New York Times has confirmed the essential details of this extraordinary story. In the Thursday, January 8, 2009, edition of the New York Times, reporter Andrew Pollack wrote a story titled “Lab Acknowledges...

Quest Diagnostics Undertakes Patient Retest Program Due to Inaccurate Test Results

Starting in October, Quest Diagnostics Incorporated (NYSE:DGX) has quietly notified certain physicians and patients that it had reported “inaccurate” lab test results for Vitamin 25(OH) D. This ongoing campaign appears to be the largest voluntary patient recall/retest program known to have been instituted by a clinical laboratory company.The Dark Report and Dark Daily are first to report this remarkable story. Quest Diagnostics has told The Dark Report that, for a period of time in...

Kennedy Targets Home Brew Tests by Introducing Laboratory Test Improvement Act

Senators Edward M. Kennedy (D-MA) and Gordon H. Smith (R-OR) yesterday introduced a bill in the Senate that aims squarely to control laboratory-developed tests, also known as ‘home brew” tests. The trigger for this bill is the growing role of genetic technology in laboratory testing. Also, the appearance of Web sites purporting to sell genetic tests directly to consumers has created a concern in some quarters that regulation of laboratory tests can help keep scam artists and bad science out of...

The FDA Seeks to Regulate New Types of Genetic Tests

In September, The New York Times reported that the Food and Drug Administration was taking steps to regulate a new category of complex diagnostic tests expected to play a growing role in tailoring medical treatments to specific patients. The new policy was published only as draft guidelines open for public comment, so the regulation has not yet become law and there is still time to voice any concerns you or your lab may have. The FDA already requires approval of diagnostic test kits that are...
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