Becton, Dickinson, and Company (BD) recently announced a strategic public-private partnership with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop diagnostics for multiple pathogens in single samples from patients with respiratory symptoms.
Under the partnership, BARDA will award BD an initial $24.7 million with the opportunity to increase up to $40.3 million for development and Food and Drug Administration 510(k) clearance of five new combination tests. The tests include:
- A rapid point-of-care antigen test that detects and distinguishes between SARS-CoV-2, influenza A, and influenza B at the point of care.
- A molecular PCR test that detects and distinguishes between SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) for hospital or other moderate-throughput labs.
- A molecular PCR test that detects and distinguishes between" SARS-CoV-1, Middle East respiratory syndrome (MERS), seasonal coronaviruses, and novel or emerging coronaviruses to address future outbreaks in hospital or other moderate-throughput labs.
- A molecular PCR test that detects and distinguishes between SARS-CoV-2, influenza A, influenza B, and RSV for core, reference, or other high-throughput labs.
- A molecular PCR test that detects and distinguishes between SARS-CoV-1, MERS, seasonal coronaviruses, and novel or emerging coronaviruses in core, reference, or other high-throughput labs to address future outbreaks.
BD officials said that COVID-19 “will be with us for a long time.” The officials added that they share BARDA’s desire to ready the U.S. healthcare system for diagnosis and treatment of known and emerging respiratory viruses.
TARA Biosystems Partners With Scipher Medicine for Cardiac Laminopathies Therapies
TARA Biosystems and Scipher Medicine have announced a collaboration aimed at discovering and validating targets for cardiac laminopathies. TARA is a biotechnology company harnessing human biology and data to transform cardiac drug discovery. Scipher is a precision medicine company. Cardiac laminopathies, associated with mutations in the LMNA gene, can result in electrical and mechanical changes in the heart. These changes can have profound clinical consequences, including cardiomyopathy, sudden cardiac death, and end-stage heart failure. Currently, there are no therapies that correct the underlying pathologies.
Scipher will leverage human molecular data analyzed by its Spectra platform, which includes data from TARA’s Biowire II LMNA disease models, to identify novel targets for a stratified disease population. This approach aims to detect proteins upstream and downstream of LMNA signaling within the Spectra network model. The
identified targets will be evaluated on the Biowire II platform, which consists of induced pluripotent stem cell-derived human cardiac tissue models, including a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease.
The companies say their partnership will reduce the time needed for target discovery and validation from years to months.
I-Mab and Roche Diagnostics Collaboration Aimed at Companion Diagnostics
I-Mab has entered a strategic collaboration with Roche Diagnostics to co-develop companion diagnostics solutions for I-Mab’s innovative pipeline. I-Mab is a Chinese clinical stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, and Roche is a global leader in the in vitro diagnostics industry. Companion diagnostics have become an important part of the innovative biologics research and development (R&D) process. They are used to detect expression levels of proteins and mutated genes, and to help identify the right candidates among patients with different types of diseases. Using companion diagnostics can help innovative biotech companies improve R&D efficiency, ensure the effectiveness and safety of drugs, and control R&D costs.
Under the terms of the collaboration, the companies will develop companion diagnostic solutions for the innovative assets under development by I-Mab. The collaboration aims to accelerate the research and development process of innovative biologics with cutting-edge diagnosis and treatment technologies.
Roche officials said the collaboration will “bring transformative medicines to benefit cancer patients globally and in China."
Agreement Between SAGA Diagnostics and AstraZeneca Eyes New Cancer Tests
A recent agreement between SAGA Diagnostics and AstraZeneca aims to help develop unique assays for undisclosed methylated targets for analyses of tissue samples and liquid biopsies. SAGA Diagnostics is a cancer liquid biopsy and genomic testing company focused on precision oncology and noninvasive ultrasensitive monitoring of cancer patients. AstraZeneca is a global, biopharmaceutical company. AstraZeneca officials said they chose to partner with SAGA because of the ultrasensitive performance of the SAGAsafe technology and the opportunity to custom tailor highly complex digital PCR (dPCR) assays to meet AstraZeneca’s desired analytical standards.
SAGAsafe is a patented improvement of dPCR that enables approximately 100-fold increased sensitivity compared with competitor methods. SAGAsafe can be used to quantify sequence variants in tissue samples as well as liquid biopsies such as blood plasma with unprecedented performance, according to SAGA.
SAGAsafe is part of a portfolio of ultrasensitive technologies, which also includes the SAGAsign technology for personalized monitoring of cancer burden and minimal residual disease using chromosomal rearrangements, as well as novel technologies in development.
Illumina Supports Israeli Newborn Genetic Diagnosis Program
Illumina has announced an agreement with Israel's Ministry of Health (MoH) for a pilot program that will sequence whole genomes of critically ill infants in neonatal intensive care units (NICU). The program, led by the Genetics Institute at the Tel-Aviv Sourasky Medical Center, will evaluate the use of whole genome sequencing (WGS) in routine care as an effective first-tier diagnostic tool to enable faster identification of disease-causing genetic abnormalities in infants and help in their clinical care and management.
Eighteen participating hospitals will enroll newborns admitted to a NICU with a clinically suspected genetic disorder, along with their biological parents. Illumina will provide its Illumina DNA PCR-Free Prep reagents for library preparation of DNA and sequencing reagents for WGS samples using the latest NovaSeq 6000 S1 v1.5 reagent kit. The 2-year pilot will lead to the creation of national reimbursement for WGS as a diagnostic tool in hospitals across Israel.
Illumina officials said the program will decrease uncertainty for the infants’ families and reduce need for iterative tests and time spent in the NICU.