Startups, Diagnostics

Harvard spinout’s test gauges HIV drug resistance using qPCR

The Harvard University spinout’s aim is to cost-effectively match patients with drugs that will actually work – that is, seek out a cocktail of HIV medication to which they aren’t resistant.

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An intriguing little Cambridge biotech startup just raised a bit of cash: LabCentral tenant Aldatu Biosciences, which is developing a diagnostics platform to gauge HIV drug resistance, just raised $100,000 in debt, according to a regulatory filing.

The Harvard University spinout’s aim is to cost-effectively match patients with drugs that will actually work – that is, seek out a cocktail of HIV medication to which they aren’t resistant.

The access to HIV drugs is actually increasing globally – with more than 15.8 million people now having access to antiretroviral drugs. More than 30 million have the disease worldwide. Aldatu points out, however, that as drugs become more accessible, resistance increases.

The diagnostics company was launched in 2014 by former Harvard University virology postdoc Iain Macleod. The first test developed by Aldatu is meant specifically for use in Africa, according to Harvard Public Health

Its platform, called PANDAA, works as an update to the oft-used polymerase chain reaction, or qPCR – and changes the HIV genome in a patient to match the test. In essence, Macleod says his test removes all of the non-resistance mutations in HIV, then conducts gene amplification to seek out single nucleotide changes associated with resistance.

Interestingly, Macleod describes “why half of the scientific community doesn’t believe that our test works.” He says:

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Because we intentionally violated every single design principle for qPCR. Everything we’re doing goes against more than a quarter century of rules that don’t take into account subsequent scientific developments. PANDAA takes all these advances and bundles them together.

The problem today is that researchers have been too busy looking for big data and big genomic answers. Traditional HIV drug-resistance testing uses standard DNA and RNA sequencing. You get information for huge regions of the genome, but only about 1 percent of that information is clinically informative.

We call PANDAA “focused genotyping.” It’s designed to get resistance infor- mation for six different discrete positions on the HIV genome—the six mutations that confer drug resistance in patients startingWorld Health Organization (WHO)-recommended first-line therapy. One or more of these mutations will be present in at least 99 percent of people failing first-line treatment in Africa. Information on the other 1,200 genetic mutations you won’t get, because you don’t need it.

The company has $1.5 million in SBIR funding from the National Institutes of Health, and was a 2014 winner of the Harvard Deans Health Sciences Challenge and Verizon Powerful Answers Award.