Aldatu Biosciences Receives $1.5 Million Direct-to-Phase II SBIR Grant from the NIAID for HIV Drug Resistance Diagnostic Development

Cambridge, MA, 12th March 2015 (download press release .pdf)

Aldatu Biosciences, a novel diagnostics platform company focused on improving HIV patient care globally, today announced it has been awarded a Direct-to-Phase II Small Business Innovation Research (SBIR) grant for approximately $1,500,000 over two years.

Supported by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), this SBIR award will fund the advancement of Aldatu’s proprietary PANDAA™ genotyping platform to a clinical diagnostic test for the sensitive detection of drug-resistant HIV in resource-limited healthcare settings.

The funding will allow Aldatu to develop the first diagnostic product for HIV drug resistance that is specifically designed to meet the clinical and economic requirements of low- and middle-income countries. The product will be used to detect clinically-actionable drug resistance mutations in patients failing antiretroviral therapy and inform cost-effective treatment decisions.

“The NIAID has placed a clear emphasis on the importance of tests to monitor resistance to HIV medications in resource-poor settings by including it as a high-priority area of research interest, and we are extremely pleased that the grant reviewers have recognized the potential of the PANDAA™ technology to address this global health need,” said David Raiser, CEO of Aldatu.

“The PANDAA™ platform was developed in the hopes that it might one day improve access to optimal HIV care to patients around the world. These funds provided by the NIAID will allow Aldatu to make important strides in achieving that goal.” Dr. Iain MacLeod, Aldatu’s Chief Science Officer

The Direct-to-Phase II SBIR award mechanism allows small businesses with advanced technology (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D that tests the functional viability of a prototype according to scientific methods and potential for commercial development. “This award speaks to the strength of the body of existing PANDAA™ data and reflects a high scientific confidence in the technical feasibility of PANDAA™-based diagnostics,” added Raiser.

Aldatu was also recently named a $250,000 winner of the 2014 Verizon Powerful Answers Award in the Healthcare category, and is an alumnus of the Harvard Innovation Lab, the MassChallenge Accelerator, and the MassCONNECT program of the Massachusetts Biotechnology Council (MassBio).

More information:
Aldatu Biosciences
Aldatu Biosciences is a Cambridge, MA-based, seed-funded 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. 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.