Sample preparation frequently presents a bottleneck for clinical molecular biology workflows and diagnostic tests. Whereas there are many molecular detection modalities, there are only a handful of automated sample preparation workflow strategies. Existing instruments that are built around these sample preparation strategies and chemistries range in cost from $17-$150k, and yet they still do not include an integrated method for lysing difficult-to-disrupt organisms such as gram-positive bacteria or the acid fast bacilli (.e., Mycobacterium). To address these limitations, we will integrate Akonni's sample preparation technologies into a low-cost automated instrument that can process a variety of sample types with simple-to-use consumable kits. Based on Phase 1 results, the two-year goal for Phase 2 is to demonstrate the efficacy of pre-production integrated sample preparation systems with a disposable M. tuberculosis/sputum DNA extraction kit in a targeted intended use setting - a clinic with a moderate to high TB burden rate.
Molecular diagnostics, which are tests that analyze the DNA and/or RNA in a sample, are becoming increasingly prevalent among clinical laboratory test methods. An important, yet challenging, procedure, required of these tests, is to remove the DNA/RNA from the sample and wash away the impurities. We seek to develop a low-cost automated instrument to address this challenge.
| Thakore, Nitu; Norville, Ryan; Franke, Molly et al. (2018) Automated TruTip nucleic acid extraction and purification from raw sputum. PLoS One 13:e0199869 |
| Thakore, Nitu; Garber, Steve; Bueno, Arial et al. (2018) A bench-top automated workstation for nucleic acid isolation from clinical sample types. J Microbiol Methods 148:174-180 |
