Talis Biomedical has won up to $8.6 million from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) toward developing a pair of rapid molecular diagnostic tests for infectious diseases.
Talis said its funding from CARB-X will fund development of a rapid CLIA-waived molecular diagnostic test designed to detect chlamydia and gonorrhea directly from a patient sample in up to 20 minutes—as well as development of a similarly fast phenotypic antibiotic susceptibility test for gonorrhea.
“Beyond our initial menu items of chlamydia and gonorrhea testing, our intent is to build on this research to deliver a broad menu of testing capability to care providers around the world,” Talis CEO Brian Coe said in a statement.
The tests are being developed as part of Talis’ molecular point-of-care (POC) diagnostic platform, designed to enable physicians’ offices and clinics to run reference lab-quality diagnostic laboratory tests.
Talis will receive $4.4 million upfront, and up to $4.2 million tied to achieving unspecified milestones.
By combining proprietary isothermal amplification chemistries, original engineering, and data science tools, Talis says its platform allows users to load sample, walk away, and review results remotely.
Talis says its platform includes SlipChip sample partitioning in hundreds to thousands of fractions, which according to the company allows accurate quantification of biomolecules within 20% variance. SlipChip is designed to help users determine susceptibility to antibiotics by measuring small molecular response differences between susceptible and resistant bacteria.
The platform also includes:
- Direct imaging or sensing of compartments for rapid qualitative assessment and multiplexing.
- Real-time quantification of individual compartments, which Talis said will ensure specificity of test and enables safe multiplexing.
- Multimode Bright Field / Fluorescence imaging, intended to enable parallel molecular, chemical and inmunoassay testing.
SlipChip’s phenotypic susceptibility approach was developed by students and postdoctoral researchers in the laboratory of Talis co-founder and board member Rustem F. Ismagilov, Ph.D., who is also director of the Jacobs Institute for Molecular Engineering for Medicine at California Institute of Technology (Caltech).
Results from the initial collaboration with Talis were detailed in “Rapid pathogen-specific phenotypic antibiotic susceptibility testing using digital LAMP quantification in clinical samples.” In the study, published online in October 2017 in Science Translational Medicine, Dr. Ismagilov and colleagues carried out antimicrobial susceptibility testing via digital nucleic acid quantification to measure the phenotypic response of Escherichia coli present within clinical urine samples exposed to an antibiotic for 15 minutes.
The researchers used their approximately seven-minute digital real-time loop-mediated isothermal amplification (dLAMP) assay, and compared the results to a commercial digital polymerase chain reaction (PCR) assay taking two hours long. They found that dLAMP can be used with SlipChip microfluidic devices to determine the phenotypic antibiotic susceptibility of E. coli directly from clinical urine samples in less than 30 minutes.
“With further development for additional pathogens, antibiotics, and sample types, rapid digital AST (dAST) could enable rapid clinical decision-making, improve management of infectious diseases, and facilitate antimicrobial stewardship,” Dr. Ismagilov and colleagues concluded.
CARB-X is the world's largest public-private partnership devoted solely to accelerating early development antibacterial R&D.
“Talis Biomedical's project could potentially speed up and improve the way drug-resistant gonorrhea and other serious diseases are diagnosed and treated,” CARB-X Executive Director Kevin Outterson stated. “The world urgently needs new diagnostics, antibiotics and other products to protect us from drug-resistant bacteria.”