Technology

device

Immunoassay tests are commonly used to diagnose a whole host of disease / medical conditions. In general the technology behind them relies on the manipulation of magnetic nanoparticles. However laboratory and Point of Care tests generally use optical technology to detect these particles; only around 30% of particles can be detected in this way, severely limiting accuracy.

Where others finish up, we start detecting. To a whole new level of accuracy: The MIDS patented technology not only uses a bespoke optical sensor like other devices, but also utilizes miniaturised, highly sensitive custom built “Hall Effect” magnetic sensors embedded within a test strip as a Lab-On-Chip device. This patented technology can detect extremely low levels (nano-Tesla) of magnetic field disturbance caused by discrete test particles; In simple terms, instead of optically reading “clumps of particles” by standard methods, magnetically identifying the signature of discrete particles is expected to produce a substantially more accurate test result within minutes. A rapid test system that accurately measures troponin I and T and other key cardiac markers is, we believe, a blockbuster technology. It should be a “Must Have” for global diagnostic companies.

Market Opportunity

The global market for cardiac biomarker diagnostic tests is projected to reach $7.2 billion by 2018, of which $1.16 billion is expected to be served by Point of Care devices. The Point of Care market is in its infancy; existing Point of Care hand held devices are not accurate or reliable enough to definitively exclude AMI. Our ultimate goal is to match or exceed current “Gold Standard” high-sensitivity cardiac assays, currently carried out on relatively slow, hugely expensive laboratory analyzers. One multinational diagnostic company claiming the highest levels of accuracy on the market for a  Point of Care cardiac marker device in reality achieves a mere 65% sensitivity (correctly identifying the condition).

This poor sensitivity comes nowhere near what we expect MIDS Cardiac™ device to achieve. And despite the shortcomings of  Point of Care cardiac devices currently on the market, 100’s of millions of dollars per year are generated from device and strip sales to simply aid the diagnosis of AMI in conjunction with ECG and clinical symptoms. We are confident that our technology platform will deliver unparalleled levels of accuracy, speed, reliability, ease of use and cost savings which will make it the device of choice for hospitals, ERs, family practitioners, paramedics and low resource settings. It is no wonder the MIDS technology is already attracting interest from a number of the global majors.

The Future

Cardiac is just the first MIDS application. The MIDS technology platform could be adapted to a vast array of Point of Care immunoassay tests, taking them to a whole new level of accuracy, cost, ease of use and speed of testing: A multi-capability Point of Care device with laboratory “Gold Standard” accuracy for testing for conditions such as Chlamydia, prostate, colorectal and other cancers, stroke tests, sports anti-doping tests, Drugs of Abuse, insulin tests, H. Pylori, Inflammatory & Autoimmune disease, Influenza, Legionella, Osteoporosis, Endocrine tests, Respiratory Virus, pneumonia, Blood infections, Streptococcus, Meningitis, Rheumatism, Hepatitis, HIV, Viral tests, and many more. These common medical tests are performed all day long at huge expense in medical testing laboratories worldwide, in a market projected to be worth $23.7 billion per year worldwide by 2019.

A successful development of MIDS Cardiac™ is expected to be the first step in the development of technology platform which can serve a whole host of these other critical tests. The MIDS technology super-accurate quantitation, applicable to a new generation of High Sensitivity medical tests, could be the most significant advance in decades, representing the Holy Grail of diagnostic testing.

Question and Answer

Cardiac troponin has been well documented as the preferred biomarker for diagnosis of myocardial infarction due to the high sensitivity and specificity for myocardial injury. Evidence continues to show that high sensitivity troponin is emerging as one of the most powerful prognostic biomarkers for the assessment of cardiovascular risk in the general population. Over the past 10 years cardiac troponins T and I (cTnT and cTnI) have emerged as the cardiac biomarkers of choice for the diagnosis of Acute Myocardial Infarction (AMI, heart attack).

High sensitivity troponin assays (hs-cTn) carried out on laboratory analyzers have yet to be approved for clinical use in the United States, although they are in clinical use in other parts of the world, including Europe, Canada, and Australia. These tests achieve very high levels of accuracy but the process is slow, impacting the crucial turnaround time (TAT). These analyzers are also extremely expensive. Numerous alternative Point of Care devices are available. They are regularly used because of their fast TAT, no other viable option being available when time is so critical. However the analytical gap between high sensitivity laboratory analyzer tests and Point of Care assays for cardiac troponin is considerable. In reality there are no high sensitivity Point Of Care devices available for clinical practice in the “Golden Hour” which can compare with the growing use of high sensitivity central laboratory cTnT and cTnI assays currently in use outside of the USA.

Laboratory analyzers and Point of Care tests are generally carried out by manipulating tagged magnetic nanoparticles and using optical technology to detect them. Large central laboratory analyzers use state of the art 2D cameras during this process, have the capabilities to run multiple tests simultaneously, and embody other techniques to achieve high sensitivity results.

Point of Care devices, due to their considerably smaller size, cannot miniaturize the same technology. They are limited to optical detection of a lesser capability. In simple terms the nanoparticles are only viewed one or two dimensionally by the optical-sensing techniques. Only surface visible analytes are detectable.

In contrast the MIDS technology is capable of detecting extremely low levels magnetic field disturbance (nano-Tesla) caused by discrete test particles. This should allow detection on a three dimensional level by detecting and measuring the magnetic signature of discrete assay nanoparticles using a lab-on-chip, multiplexed test strip. Nanoparticle size is also crucial. Whereas the newest Point of Care device on the market claims to work with particles down to only 200 nm in size, the MIDS technical team has previously demonstrated that the MIDS technology can detect 40 nm sized nanoparticles. During optimization the intention is to achieve detection down to 10nm size. Reducing the test particle size offers even greater levels of test accuracy and this, in combination with detecting very low counts of smaller nanoparticles, offers the prospect of developing a new Point of Care device with accuracy equal or superior to existing high sensitivity laboratory tests.

In summary, the MIDS technology should deliver orders of magnitude accuracy improvement in an inexpensive, easily operable device, in minutes from a small finger prick sample with rapid and unparalleled TAT. Effectively the Holy Grail of POC testing, MIDS for cardiac markers can accelerate diagnosis of suspected AMI at first medical contact, revolutionizing the triage, enabling early patient treatment and disposition, saving lives and dramatically reducing healthcare costs.

The MIDS technology platform (under license) is robustly protected by patent applications now in the national phase in key geographic areas and already granted in China (grants in other territories are expected to follow shortly).

The technical challenges posed by the complexities of the detection method are a natural protection over and above the formal Intellectual Property protections. The MIDS technology is, as far as we are aware, unique; it is the first miniaturized technology to have demonstrated the magnetic detection of test nanoparticles of medical assay size. The MIDS Medical approach, using miniaturized bespoke extremely high sensitivity Hall Effect sensors is a highly specialist area. The MIDS Medical team have unparalleled expertise in this field; thirty years’ experience in nano-magnetic measurement and Hall Effect sensor design, specifically in magnetic nanoparticle applications in the Point of Care field.