Martha Henry, Editor of Spotlight, sat down with MacLeod and Raiser to discuss their recent biotech start-up.
You recently won the grand prize of $40,000 for the Deans’ Health & Life Sciences Challenge hosted by the Harvard Innovation Lab (i-lab). What is your product?
MACLEOD: Our product is a rapid HIV drug-resistance test focusing on six drug-resistance mutations that are most likely to impact antiretroviral therapy in resource-limited areas.
How and why did you develop this technology?
MACLEOD: It came about from a need for better drug-resistance surveillance. I’ve worked with Chris Rowley over the past couple of years on his study looking at drug resistance in Botswana. We had a couple of approaches, but they were all cumbersome. As part of his work, Chris was looking for novel ways to detect drug resistance. It all came together one day when we developed the idea for what we now call PANDAA for “Pan-Degenerate Amplification and Adaptation.” With PANDAA, we’ve taken an existing technology called qPCR and adapted it for HIV drug-resistance testing.
When did you realize that you might have a commercial product on your hands?
MACLEOD: I guess it was a staged realization. We had approached Harvard’s Office of Technology Development in 2012. We were interested in patenting the technology primarily so that when we published our results, no one could just run off with the idea. We just wanted to protect the idea that we’d come up with.
Who could benefit from your drug-resistance test?
MACLEOD: Someone with HIV who is just about to start antiretroviral treatment, or someone with HIV who is failing an antiretroviral regimen.
How big a problem is drug resistance today?
MACLEOD: It’s growing rapidly. There are two different types of resistance. There is acquired drug resistance, so someone who’s on antiretrovirals will develop drug resistance over time. And then there is transmitted drug resistance, where someone gets infected with a strain of HIV that is already drug resistant, so even if they’ve never taken antiretrovirals before, they may be resistant to one or more drugs. One of the unfortunate side effects of the scale-up of ARVs in Africa is a corresponding increase in transmitted drug resistance.
In a place like Botswana, there’s about 5% transmitted drug resistance, but as we’ve seen in other parts of Africa, that will start to increase. In the U.S. and Europe the rate is almost 20% (in some areas) because we’ve had ARVs here for longer.
How is your product better than the existing technology?
RAISER: For resource-limited settings, we anticipate a much lower price point than the currently marketed tests, which should help increase access to testing. In addition to being more affordable, it’s also much faster, with results in a matter of hours as opposed to a matter of days. Our test is also more sensitive and picks up drug resistance earlier than current tests. Being able to detect drug resistance earlier allows for an earlier ARV treatment change, so the virus can be re-suppressed earlier, as opposed to leaving an uncontrolled infection in a patient for a longer period of time.
How did you two join together to form a company?
RAISER: Iain and I found ourselves at the same Innovation Lab workshop on Life Sciences Entrepreneurship. The workshop was a bit overwhelming, so we both ended up leaving early. While we were waiting for the bus, we asked each other why we were there. At the time I was open to the idea of being part of a startup, but the right idea really hadn’t come along. Iain said, “I think I have an idea, but I don’t really know if there’s potential here and how exactly to move it forward.” He took out a piece of paper and drew PANDAA for me. That’s when we decided to really explore the commercial potential.
MACLEOD: That was last summer. Come September, the NIH [U.S. National Institutes of Health] put out a request for a simple, inexpensive, HIV drug-resistance assay focusing on specific resistance you’d find in resource-limited areas. We thought, “That could be written for us.” All of a sudden we found ourselves applying for a grant that had to include business entry and exit and commercialization strategies. We were going to do it, but we were really kick-started by this request from the NIH.
Since winning the i-lab competition, what have you been doing to get your test to market?
RAISER: Right now our two main concerns are funding and building the relationships that will lead to the partnerships that will carry things forward. We’re talking to our scientific advisors about the best way to go about manufacturing the test. Do we do it here? Do we do it in Africa? Do we do it ourselves? Do we outsource it to others? So we’re answering a lot of questions about next steps. When funding does come in, we need to hit the ground running.
Could the PANDAA technology help with other diseases?
RAISER: Yes. We can use the design and optimization that has gone into the HIV drug-resistance test as a model to apply to other diseases that, like HIV, are highly variable.
MACLEOD: Any type of pathogen that’s constantly changing—TB, Lyme disease, influenza, hepatitis, anything where there’s a lot of variability—can prevent you from using qPCR.
RAISER: The value of the technology is being able to overcome that hyper-variability. We’ve begun to look at other infectious diseases where this could have an impact.