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FDA to regulate Lyme, other diagnostic tests now exempt from oversight

By: Beth Daley and Samantha Costanzo
New England Center for Investigative Reporting
The US Food and Drug Administration, responding to growing concerns that a host of diagnostic tests for illnesses from cancer to Lyme disease may be inaccurately identifying conditions, announced Thursday that it intends to regulate many of the tests. Thousands of tests on the market take advantage of a legal loophole that exempts them from requirements that their makers prove they correctly identify what they claim to, forcing doctors and patients to decide which tests are legitimate. FDA commissioner Margaret Hamburg said during a news conference that her agency was aware of faulty tests, such as those that led cancer patients to receive inappropriate treatment and those for autism. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether,’’ said Hamburg. Oversight will be phased in over nine years, with the first batch of highest-risk tests subject to FDA review a year after the proposed rules are finalized. Continue Reading →

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Sudden infant death: Agency-linked babies more at risk

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Children in homes supervised by state social workers die suddenly and unexpectedly at least twice the rate of infants statewide, according to an analysis of the most recent available data by the New England Center for Investigative Reporting. That suggests to child welfare advocates that more should be done to educate caretakers of some of the state’s most vulnerable children about how to minimize the risk of sudden death. Continue Reading →

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Full List of Rejected Tests

Which Tests Have Been Rejected Share Image

At least seven labs in the U.S. have been denied permission to offer Lyme tests over the past decade in New York, according to state records obtained by the New England Center for Investigative Reporting. The state is the only one that performs a rigorous review of tests to ensure they identify what they claim to before they can be offered there. Continue Reading →

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Many Lyme disease tests may not accurately diagnose patients

Deer ticks that can infect people with Lyme disease are often no bigger than a poppy seed. (Lauren Owens/NECIR)

As Lyme disease becomes an increasingly challenging public health threat across the Northeast, a growing number of tests for the vexing ailment may be misdiagnosing patients when telling them that they have – or don't have – the tick-borne illness.

An exemption in federal regulations allows many labs to offer Lyme tests without proof that they accurately identify the disease, leaving anxious patients and their doctors to decide which tests to believe.

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Lyme Testimonial


I found a tick attached to my ankle after visiting the well-known garden complex Parc Guell and attending a music festival in Barcelona, Spain in June 2013. The engorged tick fell off in the shower and two days later I noticed a bulls-eye rash on my thigh. Continue Reading →

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