- Joint Venture MIDS technology doubles detection capability in second testing round
- MIDS Technology aims to provide ambulance personnel, ERs with a fast, easy, low-cost and powerful device to diagnose potential cardiac symptoms
- Chest pain diagnosis is one of the most common challenges for outpatient medical providers to assess
When first responders provide treatment to patients complaining of chest pain, they face the critical task of determining what medical intervention is necessary with as much immediacy as possible.
Although such diagnoses can be difficult, particularly away from a clinical laboratory setting, Zenosense Inc. (OTC: ZENO), through a joint-venture ownership in MIDS Medical Ltd., is developing a cost-effective, hand-held, rapid cardiac diagnostic device, MIDS Cardiac™. The technology is aimed at first responders and clinicians for use at the point of care, to save money and lives through prompt evaluation of the patient’s condition.
More than 28 million adults in the United States alone are living with a diagnosis of coronary artery disease (CAD), the cholesterol-clogged affliction of the arteries that spurs heart attacks (acute myocardial infarctions, or AMIs) as the leading cause of death each year, according to the Centers for Disease Control and Prevention (http://nnw.fm/3ynNi). Assessing chest pain complaints in these patients, without an existing diagnosis, is a common challenge in medical settings.
“Chest discomfort is one of the most commonly-encountered complaints in outpatient medicine, and represents a major diagnostic challenge as patients often present with a broad range of non-specific symptoms or signs,” Dr. James Januzzi Jr. of Massachusetts General Hospital wrote in the American College of Cardiology’s Cardiovascular Imaging publication earlier this year as part of his introduction to a study that he helped author on heart-related diagnoses (http://nnw.fm/K1SgK).
Examining the levels of troponin protein released by damaged heart muscle in a patient’s blood has become the go-to biomarker to establish if a patient has experienced an AMI. Januzzi’s team also found that the ability to detect relatively low levels of troponin by a high sensitivity test may also provide clinicians with the ability to identify CAD in “stable” patients perhaps at risk of AMI who might not otherwise expect emergency care (http://nnw.fm/E6PpJ).
Zenosense’s MIDS Cardiac technology is being developed as a revolutionary hand-held diagnostic device for cardiac emergency triage that aims to provide a true high sensitivity single troponin I or troponin T test within three minutes, and a three-panel assay of additional cardiac biomarkers within eight minutes, in order to grant first responders in the field and the emergency room a triage ability that is not only rapid but that utilizes a device costing a fraction of a central laboratory analyzer.
The aim is to ease, accelerate and improve diagnosis of chest pain, giving first responders a vital early indication if a patient may or may not need significant and costly cardiac intervention. 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 troponin assays have been in use in other parts of the world for over seven years, including Europe, Canada and Australia. There are no point-of-care devices that can compare with high-sensitivity central lab assays for cardiac biomarkers.
The MIDS technology uses magnetic sensors to detect very low numbers of assay beads, which is expected to support a rapid test using a pin prick of blood for a single assay carried out on an easy-to-use, disposable microfluidic test strip, whereas current point of care devices rely on less sensitive optical technology.
In the new testing, the joint venture aimed to magnetically detect assay beads below the 200,000 level in order to support a finding that the technology could be effective in a high-sensitivity troponin test. Previously, the technology had detected down to around 100,000 beads; the new testing brings this down to around the 50,000-bead level, indicating that it is well within the necessary level of detection required for a high-sensitivity assay (http://nnw.fm/MlnX9). The new testing used extensively improved core sensor electronics to deliver the near-doubling of the previously obtained sensitivity level.
“MIDS is a hugely challenging development,” the venture’s Managing Director and Chief Scientific Officer Dr. Nasser Djennati stated in a news release. “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.”
The company is now planning to test microfluidic detection using the revised electronics platform and to embody a high-sensitivity assay on a test strip for the next key phase of development. It is confident that the new round of testing will deliver a material reduction in the level of bead detection when the Hall effect sensors are used in an unpackaged format in a production “lab-on-chip” test strip.
For more information, visit the company’s website at www.Zenosense.com
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