Sample-to-Answer Molecular TB Diagnostic and AMR Profiling Test

Amy Yorston
July 1, 2024
Development Collaboration Project with Prof. David Alland

Tuberculosis (TB) remains one of the deadliest infectious diseases globally. Despite advances in diagnostic methods and treatment progress is slow; close to 10.6 million people developed TB in 2022 and there were around 1.3 million deathsa. The emergence and spread of multidrug-resistant TB (MDR-TB) poses significant challenges, complicating treatment protocols and reducing treatment success rates. Promising new drugs comprise the backbone of future TB treatments, however without appropriate companion diagnostic tools, the world risks losing these new drugs to drug resistance within a few years of deployment.

Better diagnostic tools continue to be a much-needed weapon in the fight against this disease, especially those that can be deployed in resource-poor settings. To address this, we have formed an exciting collaboration with Professor David Alland’s team at Rutgers Biomedical and Health Sciences to develop an innovative TB diagnostic that will transform how TB is diagnosed and managed, focussing on settings where laboratory resources are scarce.

The Goal: A Molecular Drug Susceptibility Test

This initiative is based on work of the Alland group in developing drug resistance assays based on sloppy molecular beacon (SMB) technology and BLINK’s nanoreactor bead technology and BLINK ONE platform. The new test is intended to identify both the presence of Mycobacterium tuberculosis (Mtb) and the clinically important mutations associated with isoniazid, rifampin, ethambutol, pyrazinamide, fluoroquinolone, linezolid, bedaquiline, and pretomanid/delamanid resistance. The new system will include integrated sample processing and rapid thermal cycling technologies to produce results within 30 minutes at the point-of-care.

The innovation: sample-to-result workflows with Nanoreactor Beads

The assay’s core technology leverages BLINK’s novel nanoreactor Beads. The Beads provide a complete analysis workflow including nucleic acid extraction and purification followed by multiplex digital PCR and DNA melt analysis.

The BLINK One Cartridge is designed to accommodate mechanical lysis of the sample for nucleic acid extraction. BLINK Beads are used to partition the extracted DNA onto tens of thousands of individual amplification compartments provided by the Beads. . Amplification is followed by melt analysis.

Collaborative Effort for Innovation

This collaboration builds upon an established partnership between BLINK and Professor Alland’s teams, bringing together our respective expertise to develop a groundbreaking diagnostic tool.

Professor Alland is an expert in developing tests to diagnose TB and to identify drug resistant TB. The BLINK team has extensive experience in developing point-of-care diagnostic tools that have been widely adopted.

It is a privilege to be working together; our collective experience, expertise and knowledge elevate this project and provide an excellent use case for BLINK’s technology. Together we are well positioned to design assays that will meet the unique needs and challenges that TB presents.

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