Regular readers of this blog will be very familiar with the fledgling personal genomics industry, a diverse set of companies offering to sell you information about your ancestry and disease risk based on your DNA. They will also know that the field has been labouring under a cloud of regulatory uncertainty, since a horrendous Congressional hearing into the industry in July last year, followed by rumbling threats of an impending regulatory crackdown by the FDA.

While the shape of the FDA's planned regulation is still very much unclear - if indeed there are any genuine plans beyond public grand-standing - the tone of the agency's two-day public meeting in March (best summarised by Dan Vorhaus) gave us a hint: there's a very real chance that the agency will attempt to force consumers to access "health-relevant" genetic interpretation through a clinician.

Such a plan would have consequences that go far beyond the stifling of the personal genomics industry: excessive regulation, including the locking away of all health-related genetic interpretation behind a medical establishment that admits it is unprepared to deal with it, would raise the prices of genetic test access, create unnecessary obstacles to people with an intellectual interest in their genetic information, reduce the educational impact of personal genomics, and - most importantly - hinder innovation in the crucial field of genome interpretation. Such an outcome would be a particularly tragic mistake given that there is currently no evidence to suggest that receiving genetic risk information poses risks to consumers.

But most readers know my views. The main purpose of this post is to encourage readers to make their own opinions known to the FDA. Thanks to Dan Vorhaus, the agency reopened its period of public comment at the end of March. That means there's an opportunity here for those of us who believe in the importance of direct access to our own genetic information to directly tell the FDA what we think of plans to inhibit this access: but you only have until Monday to submit your comments.

Given the tight deadline, the best way to submit is online: go to www.regulations.gov/ and reference docket ID FDA-2011-N-0066. (Edit: Razib suggests this direct link to the submissions page.)

I've been far too quiet on this issue here over the last month due to various other commitments, but plan to finalise my submission over the weekend. If you're seeking inspiration for your own submission, the posts by Jennifer Wagner and Charles Warden on their submissions are a good place to start. Over the last month, Razib Khan has done an excellent job of waving the genomic access flag, as well as highlighting the non-trivial benefits of large-scale personal genomics for DIY ancestry research. Personal genomics companies have also come out fighting: 23andMe has encouraged the public to make their views heard at the FDA, and Pathway Genomics has engaged in some high-level lobbying. The issue has also received coverage in the mainstream press, most recently in a Wall Street Journal op-ed by author Matt Ridley.

Note that (with some notable exceptions) no-one is arguing that the personal genomics industry should be entirely free of regulation; rather, we have consistently argued that what is needed is light-touch regulation to ensure the accuracy of raw results, to punish false claims and unethical advertising, and to promote full transparency from companies to allow consumers to make an informed choice. Heavy-handed action from the FDA will do more harm than good; but unless the FDA knows that there's sufficient public support for personal genomics, they may well take that path - so let's do our best to ensure there's no doubt about that support.