- Every 43 seconds, someone in the U.S. has a heart attack
- Over six million patients visit U.S. emergency rooms reporting chest pain each year
- Chest pain symptoms can be hard to diagnose in emergencies but are vital to assessing for heart attack
- Zenosense’s handheld device aims to give first responders rapid, highly sensitive analysis of heart biomarkers
Each year, well over six million patients visit emergency rooms across the United States reporting chest pain. Most of these patients are not suffering from an acute myocardial infarction (AMI/heart attack), but they are a major burden on emergency departments, with billions of dollars spent on unnecessary admissions annually. When a suspected heart incident occurs, usually after a chest pain complaint, emergency responders turn to an immediate ECG, complemented by blood tests for the cardiac markers troponin I or T, to diagnose AMI.
The troponin element of diagnosis is problematic. When troponin levels from damaged heart muscle rise rapidly after AMI, the challenge is early detection when levels are very low. High sensitivity tests are required. These high sensitivity troponin tests have been in use in other parts of the world for over seven years, and, in 2017, the first next generation troponin assay was approved for use in the U.S. by the FDA. These tests are performed on state-of-the-art central laboratory analyzers, but they are expensive and also typically take at least an hour to turn around results, when minutes are vital. The market requires a device that can conduct high sensitivity troponin tests, at the point of care (“POC”), rapidly, cost effectively and easily.
Through its joint venture ownership of MIDS Medical Limited (MML) (www.MIDSMed.com), located at the United Kingdom’s prestigious Sci-Tech Daresbury campus, Zenosense, Inc. (OTC: ZENO) is developing MIDS Cardiac™. This handheld device aims to deliver accuracy equal or superior to these ‘gold standard’ central laboratory analyzers at the POC – taking lab testing to the patient. MIDS Cardiac aims to deliver high sensitivity results that are available within minutes. This would provide first responders with a new level of point of care device analysis. It will save valuable time during the so-called ‘golden hour’, when critical treatment is crucial to positive outcomes, and could also quickly rule out the majority of patients presenting with chest pain who are not suffering a heart attack, resulting in enormous hospital savings.
High sensitivity troponin assays (hs-cTn) have been used by thousands of clinicians around the world for many years, enabling better diagnosis in emergency departments. They have substantially assisted the safe rule-in or rule-out of AMI. The U.S. has been slow to adopt the assays, with the first next generation troponin T test approved by the FDA in early 2017. More are expected to follow from other manufacturers. Several studies have indicated that between two-thirds and three-quarters of patients could be ruled out, solely based on assay results, and safely discharged.
Frank Peacock MD, associate chief of emergency research at Baytor College of Medicine in Houston, stated that this recently FDA approved next generation assay “….is easily the best news in the last decade for emergency medicine patients presenting with chest pain” but added that centers without the right laboratory analyzers to perform the high sensitivity lab testing would be unlikely to switch, because installing those expensive analyzers would be a “multimillion-dollar endeavor.”
MIDS Cardiac is being developed to not only support these hs-cTn assays with accuracy that’s equal or superior to the latest state-of-the-art laboratory analyzers, but to do so at the POC, in the emergency room or even by paramedics in emergency situations such as in the back of an ambulance. MIDS Cardiac aims to provide a single troponin I or troponin T test within three minutes and a three-panel assay of additional cardiac biomarkers within eight minutes, providing a triage capability in emergency situations that is not only rapid but on a device which is a fraction of the cost of a laboratory analyzer. The device would only require a single pinprick of blood for a single assay test carried out on an easy-to-use, disposable microfluidic test strip.
Unlike existing laboratory analyzers and POC devices which generally rely on optical detection technology, the groundbreaking MIDS technology can detect and measure commonly used paramagnetic assay beads by their total aggregated nanomagnetic signal. This makes MIDS suitable to be incorporated into a miniaturized, cost-effective handheld device that could fill the hs-cTn gap identified by Frank Peacock.
In late 2017, Zenosense reported that initial testing had been completed on the MIDS device’s ‘Hybrid System’. Incorporating the patented MIDS technology platform, the Hybrid Strip, for initial testing purposes, aims to replicate as far as possible the planned MIDS ‘Lab on Chip’ technology. This is expected to give the very highest level of accuracy. It is anticipated to be equal to or better than laboratory analyzers, with capability of performing true ‘high sensitivity’ tests directly at the POC. The Hybrid Strip testing results (using packaged sensors) indicate that MIDS can already detect and measure very low numbers of commercial assay beads (as used in existing laboratory-based hs-cTn tests) to support hs-cTn tests which need to reliably measure down to five or six nanograms per liter of troponin at the 99th percentile. A final Lab-on-Chip MIDS test strip, using unpackaged sensors, is expected to be able to detect and measure even lower numbers of assay beads, by bringing the sensors much closer to the detected beads.
Carlos Gil, CEO of Zenosense, said November’s initial testing of the MIDS device was “an exciting phase of our development, designed to definitively prove this remarkable, novel method of detection.”
“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,” MIDS Medical Managing Director and Chief Scientific Officer Dr. Nasser Djennati added (http://ibn.fm/PJ1Aj).
For more information, visit the company’s website at www.Zenosense.com
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