Luminostics, Inc. awarded Phase II SBIR Grant

InteliSpark client Luminostics, Inc. has been awarded a phase II grant of $761,788 by the National Institution of Allergy and Infectious Diseases (NIH) for the project “a smartphone-based point-of-care test for detection of chlamydia trachomatis”.

Luminostics has developed an FDA-cleared and CE-marked smartphone-based screening test for Chlamydia trachomatis (CT) infections in women, for over-the-counter and point-of-care settings. There are almost 3 million new cases of CT in the U.S. each year, making it the most common bacterial cause of sexually transmitted infections. Though Chlamydia infections are curable with just one pill, 90% of those infected are asymptomatic. If untreated, Chlamydia can cause severe health problems including infertility.

There is a clear necessity of creating testing methods that provide accurate screening results. Current tests are expensive and have slow turnaround times, which consequently severely limits the applicability for expanding testing coverage. Point-of-care tests are more rapid and enable same-day “test and treat” approaches, yet, there is a large number of at-risk women who do not seek testing due to embarrassment/confidentiality concerns.

Luminostics’ innovative product, CLIP-CT, is a screening test designed for both at-home users and point-of-care physicians/healthcare providers. It provides rapid results by incorporating a case-like smartphone adapter and a mobile app to result readout and analysis using the phone’s flash and camera. The results will provide an unambiguous “positive” or “negative”, by using non-invasive samples, in less than 30 minutes.

With their awarded grant, Luminostics will now be able to develop the hardware and software components of the product, perform comprehensive and analytical performance studies, a human factors validation study, and conduct a large clinical study.