Quote:
The [FDA] did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
....
Once the kit arrives by mail [consumers] are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis.
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Spitting into a small tube could be
very unsafe. Yegads, what if someone missed the tube
‽ 
They—or someone else—might slip on the spittle and get injured!
Quote:
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Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.
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...And monkeys
could fly out my butt. Is the FDA acknowledging here that doctors/hospitals would perform chemo and/or surgery based on a mail-order test without
due diligence?
Quote:
due dil·i·gence (dū dil'i-jĕns)
In health care, making certain that rules and procedures are followed to avoid harming patients and staff.
Medical Dictionary for the Health Professions and Nursing © Farlex 2012
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I
thought (but I could be mistaken) that cancer screening (e.g. Pap smears, mamograms) is pretty standard these days(?)
Quote:
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The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.
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BINGO. There it is.
Doc