Talis Biomedical announces new data on CT/NG/TV multiplex test

Talis Biomedical announced new data supporting the development of its planned chlamydia, gonorrhea and trichomonas, CT/NG/TV, and vaginal infection panels. Results from these studies, presented in poster sessions at the 2023 IDSOG Annual Meeting in Denver, Colorado, support Talis Biomedical’s mission to advance health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care. Data Highlights from Talis Biomedical Presentations at IDSOG Annual Meeting July 27-29, 2023: Feasibility and preliminary performance of development-stage CT/NG/TV test for Talis One system: Preliminary clinical performance of the Talis One development-stage CT/NG/TV test was assessed using residual clinical samples initially tested by widely used, on-market molecular tests that require up to 90 minutes to generate a result. In neat male urine, positive percent agreement was 100% for CT, NG and TV. Negative percent agreement was 100% for CT and NG, and 98% for TV. In female vaginal swabs where only positive samples were tested, PPA was 100% for CT and NG, and 90% for TV. On-cartridge bead beating differentiates Talis One lysis for future development of vaginal panel: Talis Biomedical conducted a series of analytical studies to test different mechanical lysis conditions on the Talis One system to determine the feasibility of nucleic acid recovery from difficult-to-lyse fungal pathogens. Company scientists performed initial experiments to determine lysis efficiency with and without beads added to the Talis One’s on-cartridge mechanical lysis chamber. With stir bar mixing alone, target nucleic acids were only detected 100% of the time at 1000 CFU/mL. When beads were added to the stir bar containing lysis chamber on the Talis One cartridge, target nucleic acids were detected 100% of the time at concentrations as low as 125 CFU/mL, delivering an 8-fold increase in lysis efficiency. The lysis time was as short as 4 minutes. Additional experiments performed to further challenge the Talis One system included using contrived specimens of five different Candida species diluted in a DNA/RNA transport and storage medium at concentrations of 100,000, 10,000 and 1000 CFU/ml. These studies demonstrate that incorporating mechanical lysis on the Talis One system led to lysing fungal cells and releasing target nucleic acids for detection at a concentration level that is comparable to the limits of detection of three on-market vulvovaginal candidiasis in vitro diagnostic tests. Based on these positive early results, Talis Biomedical may be able to achieve these LODs while having a turnaround time that is approximately 30-90 minutes faster.