SOUTH EASTON, MA -- Pressure BioSciences, Inc. (PBI) announced they have entered into a strategic research and development agreement. Under the terms of the collaboration, PBI will develop a front-end, sample preparation method for Parabase's enhanced neonatal molecular diagnostics and newborn confirmatory testing process. The sample preparation method will be based on PBI's patented and enabling Pressure Cycling Technology ("PCT") platform.
Each year around 4 million babies are born in the United States, with approximately 400,000 admitted to the Neonatal Intensive Care Unit ("NICU"). Roughly 150,000 newborns need at least one single-gene test, since many of the approximately 4,000 identified single-gene diseases present in the first month of life. Early diagnosis is critical so that treatment to prevent mortality or lifelong debilitation can be quickly initiated. Unfortunately, it is difficult to diagnose genetic disease in newborns based on symptoms alone as 80% of cases present with nonspecific or similar symptoms that can have upwards of 160 possible different diagnoses. Serially testing single genes in these cases, which is the current state-of-the-art, can take many months and be prohibitively expensive.
Dr. Andy Bhattacharjee, Chief Scientific Officer and Founder of Parabase Genomics, said: "Parabase uses targeted next generation sequencing ("NGS") to offer comprehensive test panels to diagnose single-gene conditions in newborns. Our goal is to improve the standard-of-care in NICUs by replacing hundreds of currently used single-gene-disorder tests with our LifeTime NewbornDx™ sequencing service to simultaneously evaluate 350 genes representing genetic disorders in the newborn period. We plan to do this in a minimally invasive fashion, such as processing dried blood spot specimens that are currently taken from every newborn. In this regard, we are pleased to collaborate with our colleagues at PBI, who have years of experience and expertise in successfully extracting biomolecules like DNA from various sample types with their patented PCT Platform."
Dr. Bhattacharjee continued: "Our process will be optimized for 48-hour results, compared to the 8-16 weeks typically needed to generate a clinical report. This vast improvement in time to diagnosis should lead to better therapeutic options and patient outcomes, and lower economic burden due to less exploratory testing and shorter hospital stays."
Dr. Alexander Lazarev, Vice President of Research and Development at PBI, commented: "Performing NGS testing on dried blood spot samples is novel and far from trivial. Based on our prior success with similar specimens, we believe the PCT Platform has certain intrinsic capabilities that will enable the extraction and recovery of sufficient amounts of high quality DNA from these specimens for subsequent testing with the LifeTime NewbornDx™ NGS service."
Dr. Lazarev continued: "We look forward to working with our Parabase Genomics colleagues in helping to develop this important sequencing service, for both its possible impact on improving the lives of children through early diagnosis of genetic diseases, and for its potential commercial success for both our companies."
For more information about PBI, visit http://www.pressurebiosciences.com