Biennial stool screening on the table | Frightful discourse on genomic tests | Medicare opens wallet for sequencing | NIPT crackdown

Dear LabPulse Member,

Colon cancer screening saves lives. That's something people can agree on. But when it comes to deciding on the details, such as when screening should start, what test to use, and when to call it a day, it seems everybody has an opinion.

Today in the Annals of Internal Medicine, the American College of Physicians (ACP) stepped into the fray with the publication of a clinical guideline for colorectal cancer screening that reflects a review of multiple sets of guidelines from various associations. The ACP concluded that screening should start at age 50 and that high-sensitivity guaiac-based fecal occult blood tests or fecal immunochemical tests are both adequate for the job; however, they only need to be performed every two years, not annually as recommended by the U.S. Preventive Services Task Force.

In an interview with, Dr. Timothy Wilt, chair of the ACP Clinical Guidelines Committee, noted that most studies have evaluated the two-year screening interval -- not annual testing. In addition, many patients would welcome the chance to have easier screening regimens with the same good clinical outcomes, he noted. Less testing is, of course, also less expensive, though the cost per quality-adjusted life year gained with more screening looks reasonable, some say.

The high cost of genomic testing was the focus of a report on a survey backed by the American Cancer Society and other major organizations. Almost one-fifth of the oncologists surveyed said they rarely or never discuss costs of genomic testing with their patients, even though the topic is problematic and gets a lot of attention in the popular press. The cost of a genomic test at the time of the survey ranged from $300 to more than $10,000, and the U.S. Centers for Medicare and Medicaid Services (CMS) did not have a national coverage determination for next-generation sequencing.

In separate news, Ancestry announced a partnership with Wolters Kluwer to educate doctors about genetic tests and how to interpret them as part of its launch into health testing, with plans to scale up to millions of customers.

Last week, there was some good news on the cost front for Medicare patients seeking genetic tests. CMS published a proposed decision for national coverage of next-generation sequencing in beneficiaries with breast or ovarian cancer thought to be harboring germline mutations, which strongly affect prognosis and treatment options. The catch is that the test has to be approved by the U.S. Food and Drug Administration (FDA) for an indication targeted by treatment. Testing must also be done in a CLIA lab, with results provided to treating physicians.

Meanwhile, the U.S. National Council on Disability is calling on the FDA to get more involved in regulating noninvasive prenatal testing (NIPT). In the agency's view, the FDA should drop its policy of enforcement discretion when it comes to laboratory-developed tests, wrote Rishbha Bhagi, an associate editor at Instrument Business Outlook (IBO), a sister publication of

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