Diagnostics Play Critical Role in Medical Sector

NetworkNewsWire Editorial Coverage: Diagnostic devices are a crucial part of the medical technology sector, and many companies are pressing forward with work in this area. Zenosense, Inc. (OTC: ZENO) (ZENO Profile) has just announced breakthrough quantitative test results for its MIDS Cardiac handheld diagnostic technology, under development to provide rapid cardiac biomarker tests in emergency settings. Thermo Fisher Scientific, Inc. (NYSE: TMO) has developed devices to streamline protein characterization, improve analysis of small molecules, and improve the speed and confidence of laboratory spectrometry. Merit Medical Systems, Inc. (NASDAQ: MMSI) has recently finalized a deal with NinePoint Medical that will increase access to NinePoint’s groundbreaking platform for the detection of esophageal cancer. Abbott Laboratories (NYSE: ABT) has undertaken the U.S. launch of an analyzer to help diabetics diagnose their state of health. And Koninklijke Philips N.V. (NYSE: PHG) has acquired Remote Diagnostic Technologies to increase its offering of frontline diagnostic tools, which include invaluable devices for emergency medicine.

Identifying the Problem

Diagnostic devices may not seem like one of the most glamorous aspects of medicine, but they are among the most important. They allow medical professionals to identify the ailments of patients and provide patients with the right treatment. Without accurate diagnosis, the whole process falls apart.

This importance has led to the growth of an increasingly buoyant market in diagnostic devices driven by cutting-edge technological innovations. From handheld devices that can be used anywhere to sophisticated, highly complex machines used in hospitals by skilled operators, diagnostic technologies form a market worth billions of dollars each year. Few devices or analyzers are perfect, especially regarding speed and ease of use. New technologies that advance diagnostic sensitivity and accuracy, reduce costs or make diagnosis simpler are in great demand. Each step forward brings improvements in clinical care and a chance for innovative companies to enter the market by offering advantages over established technologies, especially at the point of care (POC).

Improving Detection for Better Cardiac Care

Zenosense, Inc. (OTC:ZENO) recently announced breakthrough quantitative testing results of its MIDS Cardiac technology platform.

Developed by the Company’s MIDS Medical Limited joint venture (MML) based at the prestigious Sci-Tech Daresbury campus in the United Kingdom, MIDS Cardiac is a handheld POC technology for the detection of heart attack. It is designed to help medical staff rapidly diagnose heart attack at an early stage and so to improve treatment. By the early detection of certain cardiac event biomarkers, MIDS Cardiac is expected to significantly accelerate the triage, diagnosis, treatment and disposition of patients reporting chest pain suspected as symptomatic of a heart attack.

Heart disease is the leading killer in the western world. In Europe and the United States alone, 15 to 20 million patients a year visit the emergency departments of hospitals reporting chest pain that could be a sign of an acute myocardial infarction, commonly referred to as a heart attack.

Swift diagnosis helps patients who are suffering from a heart attack as well as those who aren’t. It allows those with heart problems to receive the treatment they need. It also saves others from inappropriate and costly interventions. Like any good diagnostic tool, it can save lives and save money that hospitals need for other treatments.

MIDS Cardiac is designed to be just such a solution. The advantage of the MIDS technology lies in its superior detection technology and applying it to established immunoassay tests, with the first target being troponin.

MIDS goes beyond the optical technology used by most immunoassay tests. The analytical sensitivity gap between central laboratory testing platforms and existing POC testing devices is significant as this bulky optical technology has not been successfully miniaturized into high sensitivity capable, handheld devices. In contrast, the MIDS technology uses highly sensitive, custom-built “Hall Effect” magnetic sensors that allow it to detect extremely low levels of magnetic field disturbance caused by immunoassay beads. As the recent results indicate, this is expected to deliver Gold Standard, true high-sensitivity laboratory testing at the POC with results available in minutes — enabling high-sensitivity laboratory accuracy in emergency settings for the first time.

Breakthrough Quantitative Results

Early detection of heart attack by measuring very low levels of troponin released in the early stages of a heart attack is a vital unmet medical need at the POC. Key to the MIDS proposition is its highly portable, high-sensitivity ability to detect very low numbers of the microscopic paramagnetic beads commonly used in immunoassay tests and bound to these low levels of troponin.

Testing of MIDS has been underway since last year at MML’s facility at Sci-Tech Daresbury, United Kingdom. The nano-magnetic detection system and analytical electronics have been tested to gain a better understanding of how the system functions and how sensitive it is.

By running tests on different sets of beads, MML developers have been able to refine the nano-magnetic signal and filter out electronic noise to increase the sensitivity of the technology. Further testing has demonstrated the effectiveness of the improving system. While last year’s tests were successful, the recent quantitative results are even more impressive:

Using its revised magnetic and electronics technology, MIDS was able to detect the lowest quantities of beads to date (numbers confirmed by an independent study conducted by the University of Liverpool). Around 200,000 beads or less must be detected to service a high-sensitivity troponin test. MML’s quantitative testing results demonstrate that the MIDS technology can already detect as low as 50,000 beads.

The next steps are now to apply this groundbreaking technology to established assay techniques used in conventional laboratory analyzers to deliver state-of-the-art laboratory standard, high-sensitivity cardiac troponin testing at the POC.

Improving Point of Care Devices

The introduction of accurate handheld devices such as MIDS Cardiac is an important step for the POC market. Many of the most effective detection systems are too large and unwieldy to be used at the POC. Meanwhile, the handheld devices available for POC assessment lack the accuracy and reliability to definitively exclude the possibility of a cardiac condition. By miniaturizing laboratory-style and accuracy testing, Zenosense hopes to provide detection that is rapid, reliable and easily usable on the front line of medical care.

While this is a mission that will save lives, it is also one that could potentially bring the company a tidy profit. Medical sensors have been a top performer within the medical technology market for the past five years, performing even better than biotech. The global market for cardiac biomarker diagnostic tests alone is expected to reach a value of $7.2 billion this year, with $1.16 billion of that projected value in POC devices. MIDS therefore has the potential to tap into a valuable and growing market sector.

As Carlos Gil, CEO of Zenosense, said: “These results should not be underestimated. I am not aware of any other detection technology suitable for use at the POC, which comes anywhere close to achieving these results. . . . I truly believe we have a blockbuster technology in the making.”

Medical Technology Booms

Demand for ever-improving medical care has fueled the growth of many companies providing equipment and support for medical professionals.

Thermo Fisher Scientific, Inc. (NYSE: TMO) provides innovative technologies to support both patient diagnostics and medical research. The company showed off some of its latest advances at the 66thAnnual American Society for Mass Spectrometry conference earlier this month. There, it displayed devices built to streamline protein characterization, improve analysis of small molecules, and improve the speed and confidence of spectrometry work in food and environmental laboratories.

Like Thermo Fisher, Merit Medical Systems, Inc. (NASDAQ: MMSI) aims to innovate in medical devices and services. By focusing on customer needs, the company has created a diverse range of products that improve patients’ lives around the world. It has recently entered into a worldwide distribution agreement and strategic alliance with NinePoint Medical. This will provide Merit customers with access to NinePoint’s groundbreaking Optical Coherence Tomography platform, an invaluable tool in the detection of esophageal cancer. Successes like this led the company to record revenues in the first quarter of 2018.

With more than 125 years of experience behind it, Abbott Laboratories (NYSE: ABT) continues to be an important player in the medical technology field. The recent U.S. launch of its Afinion 2 analyzer provides a fast-working multi-assay platform that gives diabetics information about their state of health. It can be used in a wide variety of medical settings to give quick results and so allow patients to be analyzed and to discuss their results with a professional in a single visit. The latest generation of the company’s XIENCE heart stent has also recently been approved for use in the United States, and will provide better treatment for patients suffering from coronary artery disease.

Koninklijke Philips N.V. (NYSE: PHG), already a global leader in health technology, has recently acquired U.K.-based company Remote Diagnostic Technologies (RDT). This adds a comprehensive portfolio of emergency care solutions to Philips’ therapeutic care business, strengthening its position in the resuscitation and emergency care field and increasing its ability to drive change and enter new markets. The company already offers external defibrillators, advanced life support monitors and data management solutions, helping emergency teams to diagnose patients and provide them with the best in emergency care. With the addition of RDT’s range of diagnostic tools, the company’s position has become even stronger.

Diagnostic devices are a vital part of the medical technology sector. As they become more portable and more accurate, they help doctors to save lives and improve patients’ chances of survival, while simultaneously supporting the growth of influential medical tech companies.

For more information about Zenosense, please visit Zenosense, Inc. (OTC: ZENO).

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