Aldatu Biosciences Receives $3 Million SBIR Grant to Expand PANDAA-based HIV Drug Resistance Diagnostic Development

Boston, MA, 7th February 2016 (download press release .pdf)

Aldatu Biosciences, an early-stage biotechnology company developing reagents and products for the diagnosis of drug-resistant HIV, today announced it has been awarded a Direct-to-Phase II Small Business Innovation Research (SBIR) grant for approximately $3,000,000 over three years. From the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH), the award will fund the continued advancement of the company’s proprietary platform technology, PANDAA, and its specific application to HIV genotyping.

Previously, Aldatu was awarded a Direct-to-Phase II SBIR from the NIAID for the development of reagents and products to detect specific changes called SNPs in the HIV genome associated with resistance to reverse transcriptase inhibitors (RTIs) commonly found in adult first-line antiretroviral (ARV) drug regimens recommended by the World Health Organization (WHO). This new award, also from the NIAID, will allow Aldatu to further apply the PANDAA technology to reagent and product development for the diagnosis of resistance to HIV protease inhibitors (PIs) commonly found in pediatric first-line and adult second-line ARV drug regimens.

“In short, the work enabled by this grant will significantly expand the patient reach of PANDAA-based diagnostic tools” Dr. David Raiser, Aldatu’s Chief Executive Officer

“As a result of massive ARV access expansion efforts over the next five to ten years, millions of patients will soon be taking protease inhibitors as part of their anti-HIV drug cocktail”, said Dr. David Raiser, CEO of Aldatu. A test for the rapid identification of PI resistance in patients failing these drugs will have a big impact on patient outcomes by making sure that patients are matched with effective drugs quickly, and in the most cost-efficient way. With PANDAA and the funds provided by this award, we can make such a test a reality.”

By 2020, as many as 3 million adults and children are expected to be receiving PI-based antiretroviral therapy (ART), with failure rates ranging from 10-40% depending on the population. These include members of ‘priority populations’, such as adolescents and young mothers, that global health organizations like the WHO have identified as key groups to target in the expanding efforts to curtail the global HIV epidemic. The drug resistance screening product proposed by Aldatu in this funded award will be used to detect clinically-actionable drug resistance mutations in patients failing PI-based ART and inform cost-effective treatment decisions in resource-limited healthcare settings.

“We are very pleased to have received these funds from the NIAID, which has been extremely supportive of our efforts to develop affordable HIV drug resistance diagnostics using PANDAA,” said Dr. Iain MacLeod, Aldatu’s Chief Science Officer. “Our previous NIAID funding has facilitated a number of advancements to the PANDAA technology which we are eager to apply to these new reagents for the rapid and sensitive detection of resistance mutations in HIV protease.”

According to the company, the PANDAA technology uniquely enables qPCR for SNP genotyping in highly polymorphic pathogens like HIV, bringing the speed, cost, and sensitivity advantages of qPCR to HIV drug resistance diagnostic development for the first time. Aldatu’s approach to HIV genotyping is distinct from Sanger sequencing and next-generation sequencing (NGS) based tests, which generally require many steps and can take several days to return a result. The products under development by Aldatu will provide drug resistance results from isolated viral nucleic acid in under 90 minutes.

Dr. MacLeod noted that current R&D activities include drug resistance SNP detection reagent development for all major HIV ARV drug classes, including reverse transcriptase inhibitors, protease inhibitors, and integrase strand transfer inhibitors.

More information:
Aldatu Biosciences
Aldatu Biosciences is a Boston, MA-based, early-stage biotechnology company developing innovative diagnostic tools based on its proprietary genotyping platform, PANDAA. Aldatu is committed to commercializing products that address diagnostic challenges in global health, primarily in HIV and other infectious diseases, and which improve both the quality of patient care and healthcare cost-efficiency.

Aldatu is a current resident of the Pagliuca Harvard Life Lab in Boston, MA, a former resident of LabCentral in Cambridge, MA, and a graduate of the MassBio MassCONNECT program. Inquiries can be sent to

About the NIAID
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at

(BOSTON, MA) —Aldatu Biosciences, a biotechnology company developing gold standard molecular diagnostic assays and based real-time PCR, today announced it has been awarded a $3 Million Direct-to-Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The award will fund the continued advancement of the company’s proprietary PANDAA™ technology platform and its specific application to the first universal, pan-filovirus detection and differentiation of Ebolavirus and Marburgvirus, the causative agents of Ebola Virus Disease and Marburg Virus Disease.

There is an urgent global unmet market need for a standardized, commercially available pan-species filovirus test that is accessible to resource-limited settings, especially considering the growing reach of the filovirus family as evidenced by the first-ever outbreak in Tanzania that was reported on March 21, 2023.  With a case fatality rate of 88%, Marburg is one of the deadliest of the hemorrhagic fevers. The WHO reported that the 2014-2016 Ebola epidemic in West Africa generated more than 28,000 cases and more than 11,000 deaths in Guinea, Liberia, and Sierra Leone and the CDC reported that more than $3.6 billion was spent to fight the epidemic.

Challenges associated with filovirus biology have previously limited the performance of qPCR in filovirus diagnostics. Many filovirus tests are lab-developed tests and are not available for broad commercial use.  Also, current RT-PCR LDTs are only able to detect regionally endemic clades.