Uncertainty Over DAT Testing.

D r. Kimberly Lovett was frustrated. Her patient had tested positive on the fecal occult blood test used in colon cancer screening, and as a primary-care doctor in the Department of Family and Preventive Medicine at the University of California, San Diego, Lovett knew the next step in confirming the diagnosis was a colonoscopy. " But why can't you order the blood test? " demanded her patient, determined to avoid colonoscopy at all costs. Lovett responded that such a test doesn't exist, yet the patient was adamant that it did—he claimed to have seen it advertised by a Web-based company that sells blood biomarker analyses. After a tense conversation , Lovett's patient was convinced that the ad had misled him, but he left bewildered , wondering why a company can claim it can diagnose colon cancer when it can't. Many practicing physicians wonder the same thing. Direct-access testing (DAT) companies that sell blood screening capabilities to the public are becoming more widespread. These companies, which solicit orders online and then farm the analyses out to large commercial laboratories, charge far less than what doctors ordinarily charge for biomarker testing. Those who work for the DAT industry claim that their services empower patients and allow individuals to get bloodwork done without involving insurance companies , which might raise rates or drop coverage depending on results. But clinicians like Lovett also know that cancer biomarkers in particular have limited utility at best, and then only in the context of other, patient-specific data. " There's a lot of misinforma-tion out there, " Lovett says. " The danger is that patients might trust the tests more than they trust their own doctors. " Most DAT companies hire physicians or nurses who review online orders and then supply requisite paperwork to the testing laboratory closest to the ordering customer. Two commercial laboratories (which also work for hospitals, universities, and many other businesses) account for almost all DAT testing in the U.S.: LabCorp in Burlington, N.C., and Quest Diagnostics in Madison, N.J. With 1,400 domestic facilities , LabCorp accounts for the largest share of the DAT business, according to Bruce Friedman, M.D., a retired pathologist from the University of Michigan, who now runs a blog called Labsoft News. Analytical results typically go back to the DAT company, which then communicates with the customer who placed the order. Public data on DAT's growth aren't available , and …