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By Kirell Lakhman

Just when Pathway Genomics thought it was safe to sell its DTC genomic tests in a national pharmacy chain, the FDA springs out from behind the toothpaste aisle with some questions of its own.

Apparently the agency has no record that Pathway's test kit was either approved or validated by it, and it now "plans to take a hard look at any claims made by the company."

"If a company is making claims about a product that hasn't been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do," Erica Jefferson, an FDA spokeswoman, told Reuters yesterday.

But Walgreens, stepping up to the plate, argued that FDA clearance is not required to sell the kit in its stores, which already hawks pregnancy tests, paternity tests, and drug tests, all of them kits.

Pathway added that "FDA clearance is not necessary" to sell its kits "in retail" settings. Moreover, it stressed that its kits "are not intended for use in diagnosis, treatment, or for the mitigation or cure of a disease — qualities that would make it an in vitro medical device, which the FDA does regulate," according to Reuters

Dan Vorhaus at Genomic Law Report gets full points for prescience when he said yesterday that Pathway's decision to sell its tests at the corner drug store may represent the "tipping point" that opens the door to greater FDA scrutiny.

"Though this is not the first time concerns have been voiced about DTC genetic testing," he writes, "the direct comments from an FDA official are particularly striking, and suggest that these concerns may be finally be ready to produce a regulatory response."

The comments he was referring to came from Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, who said companies like Pathway "are making medical claims. We don’t know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test."

But I wouldn't start circling the wagons just yet; FDA often conducts these kinds of weak-arm tactics. But the reality is that neither the FDA nor DTC test vendors know what the agency has up its sleeve. It's constantly "looking into" an issue, "studying it," or "considering proper steps."

Consider recent and memorable comments made by Elizabeth Mansfield, director of personalized medicine at CDRH's Office of In Vitro Diagnostic Evaluation, about FDA's IVDMIA strategy (which, incidentally, will not affect current DTC genomic plays):

"We want to see what we need to do. Do we need to do anything? How much do we need to do? Who do we need to look at? Who don’t we need to look at?”

Mansfield made those remarks in January 2010. The FDA released its first IVDMIA draft guidance in July 2007. So in nearly three years the FDA still does not "see what we need to do" about IVDMIAs or whether it "need[s] to do anything." Nor does it know "[h]ow much do we need to do?" or "Who do we need to look at?" or "Who don’t we need to look at?"