The goal of this project was to develop the MMEM a sample-to-result diagnostic device. The MMEM is comprised of two independent seamlessly connected units. The first unit, termed Automatic Nucleic Acid Extractor (ANAE), extracts genomic DNA from raw bacterial samples and process it into short, clean, CPE specific oligos ready for ensuing molecular reaction. The second unit is GenoSmart’s proprietary sensor, the Miniature Matrixed Enthalpy Meter (MMEM).
During the first year of this project, we developed the ANAE into an automatic machine that isolate DNA from raw samples. The ANAE is comprised from a robotic unit and a perishable cassette. The process begins by inserting a sample into the cassette, the cartridge is introduced into the robotic unit and the DNA is processed into short specific oligos automatically and rapidly with no human contact. We have also developed the Enthalpy Meter to integrate with the sample-to-result device and increased its sensitivity.
During the second year of the project, we further evolved both units, the ANAE and the MEM, and integrated them into one fully automated, seamless, functional sample-to-result device. We have extended the capabilities of the ANAE into a standalone, universal protocol controller, able to run hundreds of independent molecular and biochemical lab procedures in a single, thermocycler-sized machine. The programable ANAE automatically performs the sequential independent steps required for various molecular/biochemical procedures, including liquid transfer and filtering, as well as magnetic separation, sonication, heating, incubation and more, as part of a preloaded or personalized run program. Specifically for this project, the output of the ANAE unit streams a few microliters of sample processed, purified, specific oligos into the MEM unit for detection of the CPE gene in question.
The MEM was modified to integrate into the device, and upon receiving the sample from the ANAE, to start the detection process. Unfortunately, the mechanical, electronical and AI steps taken for improving the sensitivity of the MEM did not meet the required diagnostic sensitivity for detecting CPE in a diagnostic environment.
In addition, we performed a comprehensive bioinformatics survey for optimizing relevant oligonucleotides sequences for detecting the CPE genes most prevalent in Europe. We have also performed regulatory and validation steps for receiving CE mark for the device.
