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Friday, April 3, 2020

Schneiderman reaches settlement with DirectLabs and LabCorp over alleged clinical testing issues

By Mark Iandolo | Jan 5, 2016


NEW YORK (Legal Newsline) – New York Attorney General Eric T. Schneiderman announced agreements with Direct Laboratories LLC (DirectLabs) and Laboratory Corp. of American (LabCorp) that will stop these businesses from giving clinical laboratory testing to New Yorkers without a licensed medical provider’s involvement.

DirectLabs has advertised “direct access” to laboratory testing. It sells requisitions to customers directly, with no physician involvement. It provides more than 250 different tests and test packages, such as tests for parasites, heavy metals, thyroid levels, vitamin levels, cancer markers and even ones for specific diseases like celiac disease and rheumatoid arthritis.

The problem, according to the attorney general’s office, is that with no physician involved, these tests can have mistakes. Physicians, with years of experience and education, should always be there to oversee the test results and give an accurate clinical overall presentation to the patient. Otherwise, these tests may have a propensity for either false positives or false negatives, giving consumers a mistaken impression of their health.

“My office is committed to helping all New Yorkers take control of their health and make educated health care decisions,” Schneiderman said. “However, enabling consumers to purchase laboratory tests for serious medical conditions without consulting a physician does not help New Yorkers control their health, but rather risks placing their health in jeopardy. Licensed medical providers are essential to ensuring consumers undergo testing that will yield clinically useful results and that the results are properly interpreted in light of the patient’s medical condition as a whole.”

Under the settlement, DirectLabs will no longer do business in the state of New York and must refund any customer with requisitions not yet presented to a laboratory for testing. LabCorp, the company that enabled DirectLabs by providing tools, must no longer accept specimens for examination pursuant to requisitions from DirectLabs or other similar companies.

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New York Attorney GeneralState of New York