Single-button device designed to streamline workflow for PCR tuberculosis diagnostics in resource-limited settings, with potential deployment across India’s primary health centers.
Co-Diagnostics has developed a proprietary sample preparation instrument designed to simplify workflow for its point-of-care PCR Mycobacterium Tuberculosis test, targeting deployment in nearly 30,000 primary health centers across India.
The Salt Lake City-based molecular diagnostics company says the new instrument delivers a low-cost, user-friendly solution for sample processing in resource-limited point-of-care and near point-of-care settings. The device supports both sputum and tongue swab sample collection methods for the company’s upcoming MTB test, which is expected to begin clinical evaluations in India before year-end.
The instrument features single-button operation and eliminates the need for measurement or dispensing tools, enabling rapid sample preparation with minimal training requirements. It incorporates a built-in safety feature to inactivate live organisms in samples and help protect test operators.
“While tuberculosis ranks as the deadliest infectious disease in the world, it is treatable and curable if diagnosed. Decentralizing PCR out of the roughly 1,000 district hospitals and making the technology available to the nearly 30,000 primary health centers currently performing microscopy is among the most significant transitions for the tuberculosis testing landscape in India,” says Dwight Egan, CEO of Co-Diagnostics, in a release.
Addressing Sample Prep Challenges
Egan notes that sample preparation has been a limiting factor for real-time PCR tuberculosis diagnostics at the point-of-care, requiring the genetic material of tuberculosis bacterium to be made accessible to PCR primers while ensuring workflow simplicity and operator safety. Sample extraction performed in centralized labs for higher-throughput PCR tests has historically been costly and time-consuming.
“The new instrument will allow us to meet our high standards for performance, cost-efficiency, safety, and ease-of-use, all while keeping production costs low and strengthening our ties with our existing manufacturing partnerships in India,” says Egan in a release.
The company believes the device represents a step toward affordable preparation of other sample types at the point-of-care, creating opportunities to expand into blood-borne pathogens testing.
Manufacturing Partnership
Systronics, a subsidiary of Ambalal Sarabhai Enterprises Limited and sister company of Synbiotics Ltd, is anticipated to serve as Co-Diagnostics’ manufacturing partner for the instrument. Synbiotics is the company’s partner in its Indian joint venture CoSara Diagnostics Pvt Ltd.
The manufacturing arrangement would allow the device to qualify for advantages of goods manufactured under India’s “Make in India” initiative, according to the company.
The Co-Dx PCR platform, including the associated tests and software, remains subject to review by the FDA and other regulatory bodies and is not currently available for sale.
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