Giffin Daughtridge, MD is the co-founder and CEO of UrSure, a venture he started with Dr. Helen Koenig at Harvard University’s Innovation Lab, and winner of the 2017 Bertarelli Prize.  Giffin kindly made time to let us know how the iLab and the Bertarelli Prize have helped him achieve his goal of reducing the spread of HIV.

How is UrSure tackling the spread of HIV?

We’re developing tests that let doctors monitor whether their patients are adhering to their PrEP (Pre-Exposure Prophylaxis) regimens. Whilst PrEP only requires a single oral dose per day to be 99% effective at preventing HIV, studies have shown that over the course of a year, adherence to even simple drug regimens can fall to as low as 20 to 50%.  Until recently the only way for clinicians to determine adherence of their patients to PrEP was through self-reporting – a notoriously un-reliable method.

Why is it important to know whether patients are taking their PrEP Medication?

Missing doses can seriously reduce the protection provided to the patient and could lead them to contract HIV.  It’s important for clinicians – and patients – to know that they are protected from infection.

UrSure is developing two tests which will give clinicians an accurate assessment of their patients’ adherence.  The first is a lab-based urine test which provides a quantitative indication of the level of PrEP medication in the patient’s system.  Whilst this is an important tool, it does not give an immediate result.  It also requires the patient to meet with their clinician on another occasion to discuss their test results.  For some patients with chaotic or busy lifestyles, this is a huge hurdle.

We were keen therefore to develop a cheaper test which gives an immediate, albeit binary, result.  We are developing a ‘point-of-care’ urine dip-test, similar to a pregnancy test, which tells clinicians whether their patient is taking their medication.

How did you realise there was need to develop this new test?

I graduated from the University of North Carolina at Chapel Hill in 2011 and went to Colombia on a Fulbright research scholarship. While there, I started a vaccination clinic for sex workers.  After a year I moved back to the US and met Dr. Helen Koenig, an infectious disease physician, who was starting a PrEP clinic in Philadelphia, PA.  In our clinic, we realised very quickly that we didn’t know with any confidence whether our patients were taking their medication – in fact, one of our patients contracted HIV, something which would not have happened if he were taking his medication as prescribed.

Helen and I started to think about how this test might be administered.  We didn’t want to develop another blood test for this group of patients and instead decided to see if a patient-friendly urine test might be the way forward.

In 2015 we incorporated UrSure Inc. in order to allow us to apply for a Small Business Innovation Research grant and to other funding streams.  I quickly realised that in order for UrSure to be a success I couldn’t run the company and complete my residency – so I decided to work on UrSure on a full-time basis after graduating medical and policy school.

How has winning the Bertarelli Prize helped UrSure develop?

For Helen and I it has been a game-changer by helping us accelerate the development of our products.  The prize of $75,000 USD, along with other prizes and funding we’ve been able to secure since, will help us develop our point-of-care test and overcome legal and regulatory hurdles that exist to new products entering the marketplace.

But the iLab Challenge is about more than just the prize fund.  Harvard’s iLab provides an incredible place to learn and develop a complete business plan.  When I started in October 2015, I had no idea how to start a company, I knew nothing about business, how to scale-up or how to create a financial model – but the great thing is, the iLab has plenty of people who do.  I sincerely believe that UrSure wouldn’t be where it is today if it weren’t for the entire iLab ecosystem – the facilities, the Challenge and the Bertarelli Prize.

What’s next for UrSure?

Now that our clinical test has been validated, we’re working with commercial laboratories to have doctors, patients and insurance companies start using the test.  Ultimately, we want to scale up so we are providing tests for as many PrEP patients as possible – there are over 100,000 in the US alone.

We’re continuing to develop our Point of Care urine test and we hope to have that ready for our clinical trials by 2018.