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True Diagnostics revs up EU prostate cancer Dx launch

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True Diagnostics gained a CE mark for its new quantitative prostate cancer diagnostic test, and the California startup will initially start selling it through distribution partners in Germany, the U.K., France, Italy and Spain.

True's test, known as TrueDx PSA, is a prostate-specific antigen hormone diagnostic. Like many on the market, it indicates when a man has elevated levels of PSA in his blood--often a key factor in patients with prostate cancer. Jerry Lee, True's president and CEO, acknowledges the similarities, but tells FierceMedicalDevices that his company's diagnostic stands out, in part, because it is quantitative and can measure the severity of a patient's condition, all through a finger prick of blood. Another market edge, he points out, is the test's relative simplicity and the quicker time to a result--15 minutes versus a couple of weeks for diagnostics that require more laborious lab processing. Specialists or small labs are the target customers.

"It's simple to use, more portable and faster," Lee told us. "Other systems or platforms require reagent refrigeration. Ours is stable at room temperature. There is no blood preparation. You don't need a venous blood draw, or to cycle [the sample] through a centrifuge, and our system requires less than 20 microliters of blood." The test is also designed to last for up to two years on the shelf. 

The PSA test, Lee notes, uses the company's TrueDx platform, which has a CE mark as well as regulatory approval in China for use as a diagnostic that measures thyroid function. True's core TrueDx platform technology can be used as a basis over time, the company says, to measure biomarkers for a variety of diseases and conditions.

Launched just two years ago, True Diagnostics has raised funding through "friends/family and a small biotech fund," CFO/COO David Larson told FMD in an email. The company hopes to raise an initial $10 million, but plans to also seek non-equity funding for specific projects and to commercialize point-of-care tests in particular markets, he noted. The company isn't very big-- there are just two full-time employees. But it relies on as many as 15 additional subcontractors, and True also contracts out its manufacturing and distribution. It offers a low-cost approach to pursuing a stake of the $21 billion, point-of-care diagnostics market.

- read the release

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