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Low-Cost HIV Resistance Testing From Aldatu Biosciences Advancing as Company Expands

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NEW YORK (GenomeWeb) – Aldatu Biosciences is expanding its team in anticipation of initiating end-user evaluations next year of its genetic test for antiviral-resistant strains of HIV in select countries in Southern Africa.

The Cambridge, Massachusetts-based startup, which recently became a registered public-benefit corporation, also received funding from a foundation focused on child health and is hoping to attract additional mission-driven investors in the future.

Antiretroviral-resistant HIV is a growing problem. Unless a patient carrying a drug-resistant strain is switched to medication that works, he or she will continue to transmit a resistant version of the virus. Yet inappropriately switching patients to more expensive medication is costly if they are in fact simply failing to take the medication properly.

"What drug resistance testing really does is, in addition to keeping patients on drugs that are effective for them and giving them the best chance at suppression, it helps cash-strapped, resource-limited healthcare systems and HIV programs to make cost-efficient decisions about which drugs are getting to which patients," Aldatu CEO David Raiser said in an interview with GenomeWeb.

Meanwhile, for patients failing drug treatment due to adherence problems and not resistance, testing would mean they would not then get more expensive drugs that they are also likely to fail. "A big source of the cost savings is avoiding unnecessary switching of patients who don't have genetic resistance," Raiser explained.

The cost benefits of HIV genotyping have been backed up by a number of studies, Raiser noted. For example, in one simulation model HIV genotype testing to determine resistance led to an increase in projected survival of HIV-infected patients by 2.2 months. "The upfront cost of the genotype test is largely offset by the deferral of a more expensive second-line regimen in patients who fail ART due to nonadherence, rendering genotype resistance testing very cost-effective," the study concluded. Another model based on data from Brazil showed slight increases in life expectancy and decreased cost if resistance testing was performed at initial treatment initiation.

The Aldatu Biosciences assay detects resistant HIV using pan degenerate amplification and adaptation (PANDAA), a method developed by co-founders David Raiser and Iain MacLeod at the Harvard School of Public Health.

PANDAA is an enabling technology for qPCR, Raiser said. It is a way of designing and using primers and probes to overcome so-called secondary polymorphisms around SNPs of interest.

"In highly variable pathogens, like HIV, the design of qPCR-based reagents to detect single SNPs has previously been precluded because of the high variability flanking those SNPs of interest, in our case those conferring susceptibility of resistance to given antiretroviral drugs," Raiser said.

The PANDAA technology compensates for these secondary polymorphisms without any reduction in specificity, enabling qPCR to be used for HIV resistance testing.

The commercial product will be a pre-filled plate that can plug into existing qPCR systems. "We're trying to make our tests cross-compatible with common qPCR platforms," said Raiser.

Aldatu is now expanding in order to sustain a few to-be-announced additional pipeline projects. The firm is hiring to expand scientific staff, including adding a qPCR technology specialist, as well as scientific team management.

The company also recently restructured from a traditional C corporation to a related, mission-focused entity called a public-benefit corporation (PBC), Raiser said. "We are still a traditional for-profit entity but we have amended our company charter to include our commitment to making positive changes in global health-related issues," he said.

Last month, CH Innovations, a subsidiary of the Charles H. Hood Foundation, invested $100,000 in Aldatu to help futher develop the HIV resistance assay. The Boston-based organization funds entrepreneurial efforts to improve the health and quality of life for children around the world.

"We're thrilled to have Aldatu as one of our early investments. They're tackling an incredibly important problem, and doing so in a thoughtful, deliberate way," John Parker, vice president of the board of trustees at the Hood Foundation and managing director of CH Innovations said in a statement.

He also noted that Aldatu's status as a PBC "clearly demonstrated the company's mission-driven approach," and that this was an important factor in the decision to invest.

Last year Aldatu won a two-year, $1.5 million grant direct-to-Phase II Small Business Innovation Research grant from the National Institutes of Health.

"A big focus of that grant was product development work, and translating our wet lab assay into a thermostable lyophilized formulation, so we've been working extensively with partners to make that happen," Raiser said.

Low cost is also a critical variable for uptake in low-resource areas. On that front, Aldatu plans to reach the centralized lab market specifically in countries with public programs. "The customers in those countries are the governments, the ministries of health, who are making the decisions about which tests will be used," Raiser said.

In-country HIV program infrastructure will then allow the test to be disseminated into individual labs. "We're treating these primary markets as almost single-customer markets, and from there it's really a question of distribution," Raiser said. The firm has existing relationships in Botswana, and is also pursuing South Africa as a primary initial target. Both countries are considered "first movers" on healthcare technology, Raiser said, but Aldatu will then have a tiered approach for entering other locations in Southern Africa in the future.

The firm also has as part of its product development process relationships with academic institutions and clinical centers in a few different countries in Southern Africa who will be participating in end-user testing of the products once they are completed, Raiser said, adding that the firm is hoping this testing will begin by the middle of next year.

HIV diagnostic tests from Alere and Cepheid recently received pre-qualification from the World Health Organization, making it more likely that certain national programs would purchase the tests. However, Raiser noted that the WHO mechanism is limited to certain types of diagnostics, and at present HIV genotyping is outside the scope of the program. "We do intend to eventually pursue regulatory approval, most likely CE-IVD marking, but [HIV genotyping] is an evolving priority for the WHO," Raiser said.  

Although many firms are working on low-cost point-of-care assays for low-resource settings, centralized labs can still play a vital role globally, and some companies seem to be targeting that market. Abbott, for example, has developed a lab-based multi-drug-resistant tuberculosis test to identify resistance to both rifampin and isoniazid. The author of a study generally assessing diagnostic laboratories in Kampala, Uganda, told GenomeWeb at the time that high-volume labs may account for only 2 percent of labs in that city, but they perform 45 percent of overall testing volume.

At Aldatu, upcoming projects in the pipeline will also be diagnostic tools for HIV, but Raiser noted that the PANDAA method can potentially be applied in other infectious disease areas. While the method was developed and patented at Harvard, in April Aldatu secured exclusive worldwide licensing to commercialize it.

"One of the terms is that the license will be royalty free in low- and middle-income countries in Southern Africa in an effort to help us to be able to offer our tests at a locally affordable price," Raiser said. Pricing will be negotiated in each region, he said, since one of the values that the test is offering is cost savings. "We are committed to working with each individual country and HIV program to establish a price that will be affordable, allowing them to implement the test broadly and realize those cost savings across the system," Raiser said.