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The announcement spread quickly through the web to Lyme disease patients across the United States. A small private lab had made an exciting breakthrough, the e-mail said, developing a sure-fire way to identify the debilitating disease in people.
To throngs of sick people in Massachusetts and the Northeast, the note offered hope that finally, they would have proof that their chronic health problems were caused by Lyme.
Two years later, Advanced Laboratory Services has conducted more than 4,200 Lyme tests, but the Pennsylvania company’s methods are coming under intense scrutiny by scientists and regulators.
Advanced Laboratory’s path underscores the often unregulated and deeply confusing world of Lyme testing. It and other companies take advantage of an exemption in federal regulations that frees them from having to prove their tests correctly diagnose the disease.
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