Q&A: A new rapid, credit card-sized UTI test for women

24 Aug 2017
Written by
Shannon Harmon

Module Innovations was founded by Sachin Dubey and Usman Khan, when they were working together at the National Chemical Laboratory in India. They recently won Discovery Award seed-funding to move forward with their rapid, point-of-care urinary tract infection (UTI) diagnostic test, U-Sense, inspired by a family member who had trouble getting treatment for a UTI.

Here they describe their technology, a small credit card-sized device that pin points the bacteria present in a sample within 60 minutes. Their aim is to change the mindset around testing for UTIs in India and get the group of people who generally suffer from UTIs the most – women – the care they need as quickly as possible.

How will your test help tackle antibiotic resistance?

Sachin: Because of the lack of facilities in many parts of India, patients either have to travel quite far to get a test done, or in many cases don’t take medication and their infections get worse.

We want our test to be at the point-of-care and to provide rapid information about the organism that is causing the infection. When a clinician has this information, they can target the infection with the right medications.

Patients taking antibiotics over the counter, when they don’t know what type and if they have a bacterial infection, is also too common in India. Resistance could be hugely reduced by our test, because people could test for which antibiotics are appropriate.

How did you become involved in diagnostics?

Sachin: I personally became interested in diagnostics when my sister-in-law had a UTI and it took three days for her to be offered antibiotics. This was in Jaipur, a very big city in India, and I began thinking about how similar issues might affect people in rural settings and what we could do to make these diagnostic processes more rapid, impacting lives at large.

 First, we want to empower clinicians to make correct and fast decisions. Secondly, UTIs mainly affect women so this is a particular group we are focusing on.

We looked at how big the problem actually is, and found it’s not just specific to India. 150 million patients globally suffer from UTIs. So apart from my personal situation which motivated us to start this, the global issue keeps us fueled.

Why is your test important? Who are the people it will benefit?

Sachin: First, we want to empower clinicians to make correct and fast decisions. The major techniques for determining bacteria and sensitivity, mainly urine lab cultures and yes/no strip tests, are time consuming or not accurate. Although our device does not indicate sensitivity, it does accurately detect present organisms, especially in situations where a lab culture is not available.

Secondly, UTIs mainly affect women so this is a group we are focusing on in particular, and we aim for our device to be easily used by other industry professionals, such as compounders and nurses.

How does your test work?

Sachin: We have created a test that diagnoses the four major pathogens that account for 96-97% of UTI cases in India.

Using a small amount of urine on a credit card-sized strip, the test can identify the presence of: E. coli, S.aureus, Klebsiella and enterococci. The four corners of the strip test correlate to the four bacteria. If the colour of a corner changes, it indicates that the specific bacteria is present. If more than one corner has a colour change, then there is a multi-bacterial infection present.

How is your test different from currently used tests?

Usman: Urinalysis or urine cultures are the most used test currently and while they indicate if there is bacteria present, this can take days. This standard test also needs special instruments, trained staff and electricity to work.

Our test tells you what type of bacteria are present within 30-60 minutes, which is a major advantage in settings where rapid results are needed, cultures cannot be performed and this is without the need of any specialised lab equipment, training or electricity.

Why did you decide to apply for a Discovery Award?

Sachin: Initially our funding came from BIRAC, and that allowed us to create our proof of concept. We eventually wanted to test this concept in some validation studies, and with this intent we applied.

The initial seed-funding from the Discovery Award will help us refine our prototype and conduct small-scale validations. In order to ensure this product works in India and all around the world, we will need to do bigger validations in different climates. We will need to obtain more funding eventually so we can ensure the test will be a good product to compete globally.

What do you need to do before applying for the Longitude Prize?

Sachin: There are cases where other bacteria might be causing UTIs, so we might miss 3-4% of diagnoses in our test. We would like to expand our test to address these organisms as well, but that’s down the line right now. If that happens we would have a 100% solid test for UTIs.

Our studies could be done in a year, if performance is exactly what we think it will be.  In parallel we are also working towards determining antibiotic sensitivity using our test. Hopefully in about a year and a half we will be ready to compete for the Longitude Prize.

What are the biggest challenges you will face in developing your test?

Sachin: When we started to develop this idea, we had a mixed bag of reactions from clinicians about how they test and treat UTIs. Some doctors who work in bigger hospitals in urban areas said they would still want to rely on a urine culture, so the challenge would be to shift their perspective on using newer devices.

At hospitals in rural settings and outside of cities, they often don't have the facilities to run a culture and currently give antibiotics out whenever people are in pain, so something like this would be very advantageous.

Our test tells you what type of bacteria are present within 30-60 minutes, which is a major advantage in settings where rapid results are needed.

There will likely be some initial hiccups with hospitals that do cultures or are developing their culture set up, but as we move forward we will have the marketing in place promoting that our test can be used on multiple patients in less amount of time.

Another challenge we face will be to develop our test to detect more than four organisms, thus making it even more accurate, but technically this should not be too difficult.

Does your technology show potential for making any other diagnostic tests?

Usman: Using the same technology for this diagnostic, we are looking to create tests for bacteria in different scenarios, such as TB, STIs and cancer. Also, not just in medical diagnostics, but, for instance, in water contamination.

How are you working to ensure your test will be available and affordable everywhere it is needed?

Sachin: We plan to work with several state governments and NGOs to make the distribution of the test robust and, hence, accessible to all. At a later point once the test is validated and ready, we plan to tie up with WHO for distribution to other developing countries. In this quest we will also seek help from organisations like Nesta.

Our Q&As are edited in partnership with the interviewee for brevity and clarity.

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