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Pressure BioSciences to Develop Front-end Sample Preparation for Parabase Genomics’ Targeted Next Generation Sequencing Testing Platform

Posted by Gabor Bethlendy

Jul 22, 2014 12:58:00 PM

Initial Target of the Parabase Sequencing Service are the Neonatal Intensive Care Units of U.S. Hospitals with a Goal of Improving the Early Diagnosis of Genetic Diseases   

South Easton, MA, July 22, 2014 – Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” or the “Company”) and Parabase Genomics (“Parabase”), (together “the companies”), today announced they have entered into a strategic research and development agreement (the “collaboration”). 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.kit2

Each year 4 million babies are born in the United States, of which approximately 400,000 will be admitted to the Neonatal Intensive Care Unit (“NICU”). Roughly 150,000 will receive at least one single gene test, as 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, CSO 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 known genetic disorders.  We plan to do this non-invasively by processing dried blood spot (“DBS”) samples that are currently taken from every baby at birth.  For this part of our process, we are pleased to collaborate with PBI, with their vast experience, expertise, and 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 to lower costs due to less exploratory testing and shorter hospital stays.” 

Dr. Alexander Lazarev, Vice President of Research and Development at PBI, said: “Performing NGS testing on dried blot spot samples is novel and far from trivial. With our past success with dried blood spot samples, we believe the PCT Platform has certain intrinsic capabilities that will enable the extraction and recovery of high quality DNA from these readily available samples for subsequent testing with the LifeTime NewbornDx™ NGS service.  We look forward to working with our colleagues at Parabase in helping to develop this important sequencing service, for both its potential commercial success and for its possible impact on improving the lives of children through the early diagnosis of genetic diseases.”

About Pressure BioSciences, Inc. Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. To date, we have installed over 250 PCT systems in approximately 160 sites worldwide. There are over 100 publications citing the advantages of the PCT platform over competitive methods, many from key opinion leaders. Our primary application development and sales efforts are in the biomarker discovery and forensics areas. Customers also use our products in other areas, such as drug discovery & design, bio-therapeutics characterization, soil & plant biology, vaccine development, histology, and counter-bioterror applications.      

About Parabase Genomics. Parabase Genomics is a privately-held, commercial-stage biotechnology company that uses targeted next generatio sequencing to offer comprehensive test panels and exomes to diagnose single-gene conditions in newborns. We currently offer the LifeTime NewbornDx™ and LifeTime RareDx™ gene sequencing services.  These are CLIA laboratory-based services serving neonatal intensive care units. Our tests employ end-to-end workflow as well as insurance pre-verification and billing services. We have developed a non-invasive sequencing method using dried blood spots, which is the first of its kind and allows us to process small sample sizes, archival samples, or work in remote locations. Our LifeTime Database™ of rare variants allows us to detect new mutations other tests would miss, thus providing a more accurate diagnosis.      

Forward Looking Statements

Statements contained in this press release regarding PBI's intentions, hopes, beliefs, expectations, or predictions of the future are "forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based upon the Company's current expectations, forecasts, and assumptions that are subject to risks, uncertainties, and other factors that could cause actual outcomes and results to differ materially from those indicated by these forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2013, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.