Zenosense, Inc. (ZENO) (the “Company”) is a healthcare technology developer that participates in transformational, disruptive medical diagnostic projects; particularly handheld devices used at the Point of Care which are displacing slow and expensive laboratory tests.
Zenosense is primarily focused on the development and commercialization of MIDS Cardiac™ through the Company’s joint venture ownership in MIDS Medical Limited (“MML”). MIDS Cardiac is in development as a cost-effective, handheld Point of Care (“POC”) diagnostic device and disposable test strip for the early, rapid detection of suspected acute myocardial infarction (“AMI”, or “heart attack”).
Identification of very low levels of cardiac markers can significantly accelerate critical triage, diagnosis, treatment and disposition of patients reporting chest pain. Cardiac troponin is well documented as the preferred biomarker for diagnosis of AMI, with evidence continuing to demonstrate that high sensitivity troponin is the most powerful prognostic biomarker for the assessment of cardiovascular risk in the general population. However, highly sensitive troponin assays are currently available only on state of the art, central laboratory analyzers. These analyzers are extremely expensive, not generally available at the POC and slow to turnaround results (typically 60 minutes) when time is critical.
True, high-sensitivity devices are not available in smaller handheld devices at the POC, where they are most needed. This is because the optical detection systems generally used in central laboratory analyzers cannot be effectively miniaturized.
MIDS Cardiac uses the patented MIDS technology platform, exclusively available to MML. Instead of using conventional optical detection, MIDS can detect and quantify assay beads nano-magnetically. This means it can be incorporated in a small device expected to achieve highly sensitive detection levels, which can support true high sensitivity cardiac biomarker tests in emergency settings, at the POC.
Harnessing world-class expertise, the MML laboratory is located at the prestigious Sci-Tech Daresbury campus in the U.K., internationally recognized for leading-edge, scientific research and commercial development. MML has the sole rights to the MIDS technology platform, which is protected by patent applications already granted in China and the USA, and applications now in the national phase in all other key geographic areas.
MIDS Cardiac aims to provide a single troponin I or T test within 3 minutes and three panel assay (additional cardiac biomarkers) on a disposable test strip within 8 minutes, using a hand-held device costing a fraction of the price of laboratory analyzers.
MIDS Cardiac should only require a pin prick of blood for a single assay test carried out on an easy-to-use, disposable microfluidic test strip. MIDS Cardiac is being designed to be operated quickly by minimally trained personnel, producing a simple to interpret result in emergency settings, even in the back of an ambulance.
Initial testing of the electronic and microfluidic components of the MIDS Cardiac “Hybrid Strip” system was completed in November 2017. The Hybrid Strip system used for development testing aims to replicate as closely as possible a fully integrated Lab on Chip MIDS test strip set-up. Development 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.
Testing revealed that a variety of brands and sizes of commercially available assay beads could be magnetically detected in very low quantities, including samples of beads that were previously undetectable. In several instances, the current “limit of detection” appeared to already be at or near to the range advised by MML’s assay consultants as suitable for a high sensitivity troponin assay.
Dr. Nasser Djennati, MML’s Managing Director and Chief Scientific Officer, said; “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.”
Cardiovascular disease is the leading cause of death in the western world, accounting for more than 17 million deaths in Europe and the United States alone. Nearly 20 million patients each year visit an emergency room with reports of chest pain, with hundreds of millions spent on unnecessary admissions to the hospital. Zenosense Inc. is confident MIDS Cardiac will deliver unparalleled levels of accuracy, speed, reliability, ease of use and cost savings, making it the future device of choice for hospitals, emergency rooms, medical practitioners, paramedics and in low-resource settings.
The MIDS technology is also seen as having a far wider application, with the platform being capable of performing Point of Care immunoassay tests for a vast array of common healthcare concerns, a market projected to be worth $23.7 billion per year worldwide by 2019. The medical testing market as a whole is projected to be worth $53.34 billion by 2021. Zenosense believes the MIDS technology could be the most significant advance in diagnostic testing services in decades.
- Global biomarker diagnostic testing market projected to reach $53.34 billion by 2021 from $27.95 billion in 2016
- Zenosense’s device development incorporates key technology which is patent protected
- Technology platform could be used to test for a wide variety of common medical conditions that typically are undertaken in laboratory setting at huge expense
- Point of Care / rapid diagnostics market expected to reach $38.13 billion by 2022