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Transforming the understanding
and treatment of mental illnesses.

Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Programs

UrSure: Testing Adherence to Prevent HIV

People living with HIV, or human immunodeficiency virus, are at an increased risk for developing mood, anxiety, and cognitive disorders. They are also more likely to be diagnosed with depression than people who do not have HIV. According to the CDC, while new HIV diagnoses have decreased in recent years, approximately 1.7 million people around the world and 40,000 people in the US still become newly infected with HIV each year.

The UrSure logo with the company’s name spelled out in a blue gradient font.
 In 2013, Drs. Helen Koenig and Giffin Daughtridge started a clinic at the Philadelphia FIGHT Community Health Centers to provide PrEP (pre-exposure prophylaxis) medication to young black men who have sex with men who were at high risk of HIV infection. PrEP is intended for people at risk for HIV, and it is highly effective for preventing HIV from sex or injection drug use. PrEP needs to be taken daily and is much less effective when it is not taken consistently. Despite the drug being 99% effective at preventing HIV infection, several patients at the clinic who were taking PrEP still became HIV positive.

Koenig and Daughtridge realized the problem was adherence—patients were picking up their medication but not taking it daily. Koenig and Daughtridge developed a lab test, which became the basis for founding UrSure, Inc., that helps health care providers measure if patients are taking PrEP consistently. Without this test, the only way for providers to determine if patients are taking their medication daily is through patient self-report – an often-unreliable method. UrSure currently has two lab-based tests available for clinical use: a urine test that identifies short-term adherence over the past 48 hours and a blood test that identifies long-term adherence over the past six weeks. A partner lab analyzes the samples and sends results back in a few days.

UrSure’s lab-based tests are currently used at 31 clinics in 11 states across the United States. In May 2020, UrSure became a wholly-owned subsidiary of OraSure Technologies, Inc., a global leader in public health focused diagnostic tests. This acquisition opens new regulatory and distribution channels to help get these tests to patients and providers sooner.

Funding from the NIMH Small Business Innovation Research program

With funding from the National Institute of Mental Health’s (NIMH’s) Small Business Innovation Research (SBIR) program, UrSure is developing a urine sample point-of-care test for PrEP adherence. Like a pregnancy test for PrEP adherence, the urine sample point-of-care test is less invasive and provides faster results.

“We were creating a brand-new type of testing that no one else was working on,” said UrSure co-founder and CEO Dr. Daughtridge. “Working with the NIMH SBIR program gave us the resources we needed to build the technology and make it viable.”

The urine point-of-care test, which is currently available for research use, allows providers to see results within a few minutes during a clinical visit. Quicker test results allow providers to intervene earlier and work with the patient to improve PrEP adherence and reduce the risk of HIV infection.

Dr. Daughtridge credits the NIMH SBIR program with helping UrSure address a public health need where no solution existed. UrSure received Phase I funding to establish the feasibility and proof of concept of the technology and Phase II funding for research and development to establish the effectiveness of the point-of-care test. The researchers were also able to participate in the NIH Commercialization Accelerator Program, which gave them access to industry expertise and connections to help them commercialize and scale up the test.

Looking forward, UrSure has received an additional Phase II grant from NIMH to develop a second point-of-care test that will use a blood sample to measure long-term adherence.

The NIMH Division of AIDS Research is committed to scientific research that will help end the HIV/AIDS epidemic. NIMH’s SBIR program provides funding to small businesses that help advance this and the overall mission of the Institute to transform the understanding and treatment of mental illnesses.

UrSure’s Advice for Other Companies Interested in NIMH SBIR Funding

“The SBIR program provides a launching pad for novel, innovative technologies that can transform patient care,” said Dr. Daughtridge. “Think about the problem you’re solving and the innovative element of your technology, and work closely with your program officer. They understand funding priorities, and they can present your ideas and help champion the work you’re doing.”

As with any large application process, Dr. Daughtridge noted that getting started can be daunting. “We looked at example applications and used them as a bit of a template,” said Dr. Daughtridge. “The key is just getting started – if you can get the process started, it’s definitely worthwhile and an incredible pipeline to get your technology to market. SBIR is really the right way to fund innovation.”