VALENCIA, SPAIN–(Marketwired – Nov 16, 2017) – Zenosense, Inc. (OTC PINK: ZENO) (“Zenosense”, the “Company”), a healthcare technology company primarily focused on the development and commercialization of MIDS Cardiac™, a Point of Care (“POC”) handheld device for the early detection of certain cardiac event biomarkers to significantly accelerate the triage, diagnosis, treatment and disposition of patients reporting chest pain and with suspected acute myocardial infarction (heart attack), is pleased to announce that its MIDS Medical Limited joint venture (“MML”) based at Sci-Tech, Daresbury (UK), has successfully completed initial testing of its “Hybrid Strip” system.
The MIDS Hybrid Strip system replicates, as closely as possible, a fully integrated Lab on Chip (LoC) MIDS test strip set-up. Testing was conducted on both the assembled Hybrid unit and its electronic and microfluidic components separately, focusing mainly on the electronics of the magnetic sensing system.
Initially a single 100µm (pure magnetite) particle was used to “coarsely tune” the magnet set up and electronic processing system. This particle produced a relatively large signal to noise ratio (“SNR”) of around 10:1, making it relatively easy to work with.
Subsequent testing revealed that low volumes of smaller, assay sized beads produce lower SNRs. The assay beads tested contain significantly less magnetic material per volume (due to composite bead construction and voids between them). Consequently it was necessary to further filter the inherent electronic noise to isolate the magnetic detection signal in a very high amplification environment, to increase the SNR.
MML methodically addressed this highly complex problem by improving the noise filtering and applying shielding & electronic component refinements, thereby achieving a ~60% net improvement in the SNR, to acceptable levels.
Testing was carried out by presenting reducing amounts of a variety of commercially available assay beads and nanoparticles to the Hall sensing electronics by a micropipette dosed carrier. MML tested seven assay bead samples from four leading manufacturers, generally in the size range of 0.5µm to 5 µm. These were mainly composite beads selected for their uniformity and handling characteristics, but having less than ideal magnetic values to challenge the detection system. In addition one sample of coated magnetite beads with more easily detected, higher magnetic values, was also tested. Ultimately, a bead type with the ideal combination of assay suitability and magnetic value will be selected for an assay to be embodied on the MIDS LoC test strip.
- All the beads could be magnetically detected in very low quantities, including samples of beads that were previously undetectable in the last round of testing.
- In a number of instances the current Limit of Detection appears to be already at or near to the range advised by assay consultants as suitable for a high sensitivity troponin assay.
- Crucially, all the beads displayed an excellent and reliable Log2 linear response (the signal doubling with a doubled quantity of beads) which is key to accurate quantitation.
MML regards these results as in line with its development plan and extremely encouraging; the Hybrid set up is necessarily constrained by its SOT-143 resin packaged sensors. This limits how closely the beads can be presented to the sensor. A final LoC strip, with unpackaged sensors, is expected to deliver considerably higher sensitivity, enabling the detection of even lower numbers of beads. On-going electronics optimization is also expected to improve the overall performance. MML is therefore confident that these factors in combination should enable detection of most, if not all, of the particles tested to be detected at a suitably low level allowing excellent flexibility to select the optimal commercially available bead type for a high sensitivity troponin assay.
Successful microfluidic flow testing of the Hybrid strip was also conducted. Commercial composite beads were magnetically captured after passing through a hydrophilic channel to collect in the very small detection area, exactly as planned. This testing has also revealed a fluid signal effect on top of the magnetic detection signal, which is expected to be routinely addressed in the next iteration of the Hybrid strip, currently being designed as part of the ongoing R&D process.
Work is now being carried out to finalise the Hybrid strip and to carry out more quantitative testing. MML will be working closely with its assay consultants throughout this process and a full update and quantitative results will be provided upon completion of this crucial stage.
Dr Nasser Djennati, Managing Director and Chief Scientific Officer of MML, commented: “These results come in at the very high end of detection expectations, even at this Hybrid strip stage. As we move forward into true Lab on Chip construction I expect detection levels to improve further still.”
About Zenosense, Inc.
Zenosense Inc.'s primary focus, through our joint venture ownership in MIDS Medical Ltd., is the development of a cost-effective, hand-held Point of Care rapid cardiac diagnostic device, MIDS Cardiac™, and is also the holder of an exclusive global license agreement to develop and market effective medical devices for use in hospitals and primary healthcare settings targeting the early detection of both deadly bacteria and certain cancers in the exhaled breath of patients.
Statements in this news release that are not statements of historical fact are forward-looking statements, which are subject to certain risks and uncertainties. Forward-looking statements can often be identified by words such as “expects,” “intends,” “plans,” “may,” “could,” “should,” “anticipates,” “likely,” “believes” and words of similar import. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Actual results may differ materially from those expressed or implied by forward-looking statements due to a variety of factors that may or may not be foreseeable or within the reasonable control of the Company. Readers are cautioned not to place undue reliance on such forward-looking statements. Additional information on risks and other factors that may affect the business and financial results of the Company can be found in filings of the Company with the U.S. Securities and Exchange Commission, including without limitation the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K for the year ended December 31, 2016 filed on filed on April 17, 2017, and in Company reports filed subsequently thereto. Except as otherwise required by law, the Company disclaims any obligations or undertaking to publicly release any updates or revisions to any forward-looking statement contained in this news release to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Respective statements concerning the development of both MIDS Cardiac™ and other devices under development have been made based on information obtained from MIDS Medical Ltd. and Zenon Biosystem, which the Company believes to be accurate, but have not been independently verified.
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