Mode Diagnostics is seeking European regulatory approval in 2013 for a do-it-yourself home test for colon cancer, with an eye toward an FDA-signoff within 18 months thereafter. And that's big news for the industry at large.
Bloomberg reports on the Scottish company and the test's advance in the context of the larger market, which is already past the $2 billion global mark and growing 20% annually for various diseases, ranging from colon cancer to HIV, chlamydia and stomach ulcers, among many others. As the story explains, the idea here is that an increasing number of consumers are more disease-savvy and look to web diagnostic tools. With that in mind, Mode is poised to ride a trend that many other diagnostic companies haven't quite touched yet.
Its digital test is simple, in which patients, at home, simply place a stool sample into a canister filled with a diagnostic solution/electrochemical biosensor. Results take a matter of minutes, versus weeks or more after clinicians traditionally send stool samples to a laboratory for testing. And assuming results come back positive, then patients must follow-up with their doctors, Mode CEO Paul Heaney explained to Bloomberg. And the company is working to expand its technology for other diseases such as chlamydia.
Mode's do-it-yourself colon-cancer test is the first on its plate and would sell for $38 online through Amazon.com and other online retailers. And assuming European approval comes through, the test could reach the market by mid-2013, Bloomberg notes.
And Mode is far from alone. The company faces at least one major rival in the self-diagnostic test market--the U.K.'s 1st Health Products, which Bloomberg explains sells more than 10,000 home tests annually focused on chlamydia. In the U.S., OraSure last year gained FDA approval for OraQuick, the country's first rapid at-home diagnostic test for HIV.
- read the Bloomberg story
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