INSPECTR - A breakthrough platform for cell-free molecular diagnostics

There is an unmet need for low-cost, simple-to-use, shelf-stable nucleic acid diagnostics. Despite the growing market size and global impact of molecular diagnostics, there remains a gap in providing this technology directly to individuals in a format that is as cost effective and as simple to use as a lateral flow immunoassay. Existing molecular diagnostic systems highlight a key tradeoff between cost and simplicity, with higher cost instruments and consumables required to enable a simpler workflow with improved usability. There are currently no FDA-approved over-the-counter molecular diagnostic tests, as current nucleic acid detection technologies struggle to achieve the price, usability, and deployability criteria for such a test.

Sherlock Biosciences has developed a platform for cell-free molecular diagnostics called INSPECTR to address this need. INSPECTR (Internal Splint-Pairing Expression Cassette Translation Reaction) leverages cell-free systems for sensitive detection of nucleic acids at ambient temperature with single nucleotide resolution. The highly programmable nature of INSPECTR enables the flexibility to link the detection of any nucleic acid input with any nucleic acid or protein output. We have demonstrated that INSPECTR can be coupled to an inexpensive lateral flow readout, serving as the first demonstration instrument-free, amplification-free, ambient temperature nucleic acid detection. Our breakthrough platform combines the specificity, rapid development, and broad applicability of a molecular diagnostic with the low-cost, stability, and direct-to-user applicability of lateral flow immunoassays.