Jun 19, 2018
OTC Disclosure & News Service
Breakthrough Quantitative MIDS Testing Results
VALENCIA, SPAIN, June 19, 2018; Zenosense, Inc. (OTC PINK: ZENO) (“Zenosense”, the “Company”), a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce that its MIDS Medical Ltd. joint venture (“MML”) has successfully completed a second testing round of its revised detection system.
In 2017 the first next generation troponin assay for the early diagnosis of heart attack was approved for use in the U.S. by the FDA. High sensitivity (“HS”) troponin assays have been in use in other parts of the world for over 7 years. These assays are performed on state of the art central laboratory analyzers, which are expensive and typically take about an hour to turnaround results, when minutes are vital. The key to the MIDS technology is its ground breaking ability to magnetically detect and measure diagnostic assay beads in low enough numbers to support a HS troponin assay. MML aims to embody this highly compact technology into an easy to use, hand-held MIDS Cardiac device for rapid diagnosis in emergency rooms, or by paramedics responding to chest pain patients at the scene.
- Extensive revision and improvements to core Hall effect sensor electronics during H1 2018
- Testing on new electronics which confirms and materially improves upon the testing results announced in late 2017, with a near doubling of sensitivity
- Results achieved using two leading brands of commercially available assay beads
- Assay bead numbers detected are well within the Limit of Detection (“LoD”) required for a HS troponin assay
2018 Quantitative Testing Results
Quantitative testing was conducted to (a) determine the minimum number of assay beads that can be detected; and (b) to prove linearity of detection signal to quantified bead numbers. MML has been advised by Future Diagnostics Solutions B.V. (a leading assay developer engaged to MML) that a capability to detect below 200,000 assay beads and preferably less than 110,000 is required to support a HS troponin test.
Two brands of beads were tested: GE Sera-Mag™ (3μm) and Thermo Fisher Scientific M-270 Dynabeads® (2.8 μm), both of which are regarded as suitable for a HS troponin assay and have similar paramagnetic characteristics.
The MIDS LoD of both these brands was seen on a reliable, repeatable basis at around 50,000 beads, with good signal linearity (required for accurate assay quantitation) at higher numbers. This number of beads detected at the LoD is approximately four times lower than the maximum threshold and therefore well within the range advised by Future Diagnostics as suitable for a HS troponin assay.
MML Managing Director and Chief Scientific Officer Dr. Nasser Djennati commented: “MIDS is a hugely challenging development. The results of this second round of testing are quite extraordinary, as magnetic detection at this level for this application is unheard of. We can now move forward and apply the MIDS detection to established assay techniques used in conventional analyzers as we seek to deliver state-of-the-art laboratory standard, high sensitivity cardiac troponin testing at the Point of Care.”
MML has revised its core Hall Effect sensor electronics during the first half of 2018 to further enhance the ability of MIDS to detect and accurately quantitate the nano-Tesla magnetic signal of the relatively low numbers of assay beads required for a HS troponin assay.
MML estimates that compared to the previous electronics, the sensitivity of the platform has been improved by a factor of nearly 2, as well as materially improving its stability.
Independent, Third-Party SEM Verification of Bead Numbers
MML has carried out an in-house Scanning Electron Microscope investigation (“MML SEM”) and has received a confirmatory study carried out by the Condensed Matter Physics group and Materials Innovation Factory at the Department of Physics of the University of Liverpool (“Liverpool SEM”). The MML SEM and Liverpool SEM indicate that a maximum of around 92,000 beads (Liverpool SEM) were previously detected at the LoD in 2017.
The recent quantitative testing on the improved electronics has demonstrated a substantial improvement on the initial testing results, now indicating that approximately 50,000 beads of a type suitable for a HS troponin assay can be detected at the LoD.
The Company is delighted that the achieved detection of around 50,000 beads is already considerably lower than the maximum number suitable for a HS troponin assay. It is confident that a further material reduction to this number at the LoD can be achieved when unpackaged Hall effect sensors are used as planned in a production lab-on-chip test strip.
MML is now planning the next key phase of development to test microfluidic detection on the revised electronics platform and to embody a HS assay on a test strip.
Carlos Gil, CEO of Zenosense, commented: “These results should not be underestimated. I am not aware of any other detection technology suitable for use at the Point of Care which comes anywhere close to achieving these results. We are now so far within the limit of detection I am extremely confident that high sensitivity rapid troponin testing can become a reality in emergency settings. Achieving these results is a huge step towards that. I truly believe we have a blockbuster technology in the making.”
Dr. Dave Dekkers, Scientist at Future Diagnostics Solutions B.V. said: “We are impressed by the achievement of MIDS Medical Ltd. for the detection of 50,000 beads with their Biosensor. Future Diagnostics will follow MML closely on their progress with the further development of this sensor.”
About Zenosense, Inc.
Zenosense Inc., through a joint-venture ownership in MIDS Medical Ltd., is primarily focused on the development of a cost-effective, hand-held Point of Care rapid cardiac diagnostic device, MIDS Cardiac. MIDS Medical applies patent-protected magnetic nanoparticle detection technology and a development team with world-class technical expertise. The MIDS Cardiac device and test strip is being designed to support a variety of rapid high sensitivity cardiac biomarker tests, with a focus on troponin I and T, to identify or discount Acute Myocardial Infarction with accuracy equal or superior to high sensitivity assays performed on laboratory analyzers. To find out more about Zenosense, visit www.Zenosense.com
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, 2017 filed on filed on April 17, 2018, 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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