Development Path

Covid-19 will be with us for a long time. One obvious reason is because of the rapid ways the virus mutates. Another is the direct admittance of vaccine developers about the reduced efficacies of their own respective products over time coupled by their declaration of the need for occasional boosters. The market for Covid19 tests will probably shrink but savings lives is not just about financial opportunities. We believe that medical clinics, and even homes, will need diagnostic tools that can delineate between the flu, an allergy, a cold, and a Covid infection. A Covid19 infection, from both symptomatic and asymptomatic carriers, can pass the virus to unsuspecting family members or even strangers who are immunocompromised. Because the technology already exists, having diagnostics devices handily available is just common sense.

We have Covid-19 diagnostics prototypes that may be helpful because they are unique in certain characteristics: rapid, accurate, portable, easy to use, and quantitative. Our diagnostic devices will also have a data platform that will allow results to sync with EMRs and mobile devices.

The prototypes that are in the final stages of validation in the USA are as follows:

• We have a Covid19 Neutralizing Antibody Test (Kit and Device) that quantifies the N-protein in blood specimens. Theoretically, the device can measure the level of immunity of a person against the virus. We intentionally developed the device with this in mind. If we are able to establish a still non-existent standards in rapid and quantitative kit and device that create a quantity-based standard for a particular biomarker, then theoretically, we can develop devices to measure levels of immunities for other pathogens as well. This changes the healthcare landscape in ways that is almost unimaginable. Vaccines will be predictive rather than be based on estimations…on different pathogens.
• We have a Covid19 Antigen Test (Kit and Device) that uses specimens taken from the nasal passages…very similar to those available in the market today that exhibit ease-of-use that doesn’t give patients uncomfortable experiences. The difference is that ours exhibited a 99% accuracy using mPCRs as a comparable test in the 1st set of validations that we conducted in Asia. Although, final validations are being conducted in the US, anywhere near the initial results we achieved during our Asian clinical trials would be ground-breaking in itself. Other antigen tests in the market have accuracies ranging between 50% to 70%. The difference in accuracies is huge if you apply the mathematical model testing hundreds of thousands of people, or even millions, in an infectious disease scenario. Applied to other pathogens, this level of accuracy employed to most pathogens will be a positive inflection point in healthcare.

GeneHarmonics Inc., the parent company of NanoHarmonics Inc., is pursuing a post-Covid development path as well. We are looking at several areas of interest that we believe will spur accelerated change in the diagnostics world because of the convergence of diagnostics technology, market dynamics, and other distribution and supply chain infrastructures that we have already built.

DIRECT TO CONSUMER TESTS. Direct to consumer is a category assigned by the US-FDA to tests that require very little or no regulatory approvals at all. Hence, “development to market” is a very streamlined and short process. We have identified more than 2 dozen tests belonging to this category and have started the development on 5 of them as “proof of concepts” – not only from a “development” standpoint but from a “development to market” standpoint.

Direct-to-consumer testing promotes awareness of specific diseases. It provides personalized information about ones health, disease risk, and other traits. It allows people be more proactive about their health. “The global market for Direct-to-Consumer (DTC) testing should grow from $1.4 billion in 2020 to $2.6 billion by 2025 with a compound annual growth rate (CAGR) of 14.2% for the period of 2020-2025. (Source: Direct to Consumer Testing Industry: Global Markets – February 2021 BCC Publishing HLC269A.”

It is notable that this study is based on technologies wherein specimen samples taken from the are sent to third party laboratories with results taking days or weeks. A rapid 15-minute test that can done at home will expand the market exponentially because it gives people data about their health concerns almost instantaneously – accurately.

Under development are a follows:

• VITAMIN D TEST
• OVARIAN RESERVE TEST
• SYPHILIS TEST
• HEPATITIS TEST
• HIV TEST

INFECTIOUS DISEASES. In line with our collective goal – that made possible our collaborations with Universities and other sectors – of creating predictive models to fight infectious diseases on the global stage using diagnostics and data science, we are starting the development of Quantum Dot portable, rapid and quantitative diagnostics for Malaria, Dengue, Tuberculosis and other diseases ravaging communities in different parts of the world. As published “The rising demand for diagnostic tools in malaria is one of the primary factors driving the malaria diagnostic market. In recent years, there has been a renewed interest and commitment by World Health Organization (WHO) to eliminate the cases of malaria in around 35 countries by 2030. By 2016, WHO estimated 216 million clinical episodes, and 445,000 deaths due to malaria, globally. Thus, the need for different types of diagnostic tests plays a vital role in the detection of clinically significant malarial cases which is expected to increase the demand for the diagnostic tools for malaria detection. Source: https://www.marketwatch.com/press-release/malaria-diagnostics-market-size-outlook-leading-players-share-industry-updates-future-growth-business-prospects-region-trend-application-types-data-analysis-and-global-forecast-2022-2027-2022-03-08.” The world needs new technology to combat these infectious diseases.

SEPSIS TEST. A rapid and quantitative sepsis test is one of our priorities. In this day and age, mortalities in sepsis shocks is 40%. A high percentage that is attributable to the absence of a timely diagnostic device. Sepsis impairs the flow of blood to vital organs, such as brains, lungs, and kidneys.

Up until this time, providers are still looking for physical symptoms to assess whether patients are going through sepsis like changes in mental state, blood pressure drops, and respiratory rates. The global sepsis diagnostics market is a $ 627 million market using old tools. A rapid quantitative toll will capture that whole market and will save lives.

OTHER INNOVATIONS. NanoHarmonics is pursuing major innovations in diagnostics beyond the introduction of biomarker-specific kits. We are confident that we are in a very strong position to achieve the following targeted milestones:

• The first Quantum Dot Rapid and Quantitative multi-diagnostics assay in the whole world.
• The first miniaturized Quantum Dot Rapid and Quantitative single and multi-diagnostics assays that is integrated with a data platform capable of data anonymization and secured cloud transmission for deployment in remote areas, homes, military operations, port of entries, and other areas.
• The mapping out of predictive models that can help manage infectious diseases.