Contract Pharma Staff05.06.20
The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) has awarded Tangen the Second Option of a contract to develop a molecular diagnostic platform that can be used by Tangen Biosciences Inc. to rapidly develop infectious disease tests. Last week, BARDA also announced that Tangen was awarded a separate contract to develop a rapid SARS-CoV-2 test for detection of COVID-19 infection utilizing Tangen’s platform.
The molecular diagnostic platform development contract was initially awarded in September 2017 with the objective of developing a rapid, highly sensitive Point-of-Care assay for Anthrax. The Base Period and the First Option were valued at $7 million and the newly funded Second Option, starting in May 2020, is valued at $3.3 million. With BARDA’s support, Tangen successfully delivered the milestones set from the First Option and is now entering into the Second Option of the contract – to conduct a clinical trial for a bloodstream Anthrax diagnostic using the fully developed and integrated TangenDx platform. Tangen intends to submit a 510(k) premarket notification to FDA for the TangenDx – Anthrax assay and Tangen’s GeneSpark instrument before the end of 2020.
Tangen achieved high sensitivity for detection of Anthrax from a blood sample. Independent testing at Battelle Memorial Institute demonstrated that the TangenDx – Anthrax assay consistently detected Anthrax virulence genetic markers with sensitivity lower than 10 CFU/ml, directly from whole blood samples in less than one hour. In addition, this contract funded the development of a prototype antimicrobial-resistant gene panel that demonstrated the multiplexing capability of amplifying multiple targets within one sample in a single run. This set the foundation for the Tangen – Antimicrobial Resistant Panel which targets the diagnosis of bloodstream bacterial infection and associated resistant genes in one hour directly from whole blood, without the need for blood culture.
Contract for COVID-19 Assay
Under a separate contract with BARDA, Tangen is developing its TangenDx – COVID-19 assay, which will run on Tangen’s GeneSpark instrument, funded by the BARDA contract mentioned above. The new contract will be used to develop a Point-of-Care SARS-CoV-2 diagnostic assay for FDA Emergency Use Authorization. Tangen’s COVID-19 assay is designed to use respiratory specimens in CLIA-waived settings.
"The BARDA funding has contributed to the creation of a small, portable yet very powerful molecular diagnostic Point-of-Care platform. The GeneSpark instrument is designed to enable rapid drop in assay development with the flexibility built into the manufacturing at our facility in Branford CT,” said John Davidson, co-founder and chief scientific officer, Tangen. “We hope to bring our instrument and COVID-19 test to nursing homes, quarantine facilities, retail clinics, urgent care, doctor’s offices, wherever it is needed."
The molecular diagnostic platform development contract was initially awarded in September 2017 with the objective of developing a rapid, highly sensitive Point-of-Care assay for Anthrax. The Base Period and the First Option were valued at $7 million and the newly funded Second Option, starting in May 2020, is valued at $3.3 million. With BARDA’s support, Tangen successfully delivered the milestones set from the First Option and is now entering into the Second Option of the contract – to conduct a clinical trial for a bloodstream Anthrax diagnostic using the fully developed and integrated TangenDx platform. Tangen intends to submit a 510(k) premarket notification to FDA for the TangenDx – Anthrax assay and Tangen’s GeneSpark instrument before the end of 2020.
Tangen achieved high sensitivity for detection of Anthrax from a blood sample. Independent testing at Battelle Memorial Institute demonstrated that the TangenDx – Anthrax assay consistently detected Anthrax virulence genetic markers with sensitivity lower than 10 CFU/ml, directly from whole blood samples in less than one hour. In addition, this contract funded the development of a prototype antimicrobial-resistant gene panel that demonstrated the multiplexing capability of amplifying multiple targets within one sample in a single run. This set the foundation for the Tangen – Antimicrobial Resistant Panel which targets the diagnosis of bloodstream bacterial infection and associated resistant genes in one hour directly from whole blood, without the need for blood culture.
Contract for COVID-19 Assay
Under a separate contract with BARDA, Tangen is developing its TangenDx – COVID-19 assay, which will run on Tangen’s GeneSpark instrument, funded by the BARDA contract mentioned above. The new contract will be used to develop a Point-of-Care SARS-CoV-2 diagnostic assay for FDA Emergency Use Authorization. Tangen’s COVID-19 assay is designed to use respiratory specimens in CLIA-waived settings.
"The BARDA funding has contributed to the creation of a small, portable yet very powerful molecular diagnostic Point-of-Care platform. The GeneSpark instrument is designed to enable rapid drop in assay development with the flexibility built into the manufacturing at our facility in Branford CT,” said John Davidson, co-founder and chief scientific officer, Tangen. “We hope to bring our instrument and COVID-19 test to nursing homes, quarantine facilities, retail clinics, urgent care, doctor’s offices, wherever it is needed."
