RECOGNIZE: Accurate SARS-CoV2 Diagnosis

Our solution is to deploy RECOGNIZE, an accurate, rapid and robust multi-modal platform for the detection of SARS-CoV-2 virus based on virus structural proteins and RNA.  This platform uses synthetic molecular recognition sensors that can be detected through both optical and electrochemical detectors. This orthogonal and integrated approach provides the highest possible sensitivity and specificity by recognizing multiple elements of SARS-CoV-2 in one rapid, accurate and easy to use test.  This platform can be incorporated with off the shelf components for optical and electrochemical detection devices that are adaptable to single throughput for self-testing (i.e., glucometer), as well as a mid- or high-throughput devices for rapid testing at restaurants, universities, airports, other congregational places such as nursing homes and refugee camps.  Unlike antibodies, aptamers and other affinity binding recognition systems that take a very long time to develop and validate, the synthetic recognition sensors can rapidly be developed and validated.

Rapid response to emerging threats: Our RECOGNIZE platform for SARS-CoV-2 will be developed as a multimodal technology that has the highest possible specificity and sensitivity for the screening and detection of people who are infected with SARS-CoV-2.  This platform will utilize a panel of selective molecular recognition sensors that detect of the virus itself, structural proteins of the virus as well as unique viral RNA sequences.  In this platform, synthetic molecular recognition sensors to coronaviruses will detect the virus in liquid biopsy samples, such as mucus collected through mouth/nasal swabs, or exhaled breath and then synthetic molecular recognitions directed to specific RNA sequences in SARS-CoV-2 will determine the presence of this virus specifically.  For a large population testing, a test with greater than 99% accuracy would be ideal, an orthogonal approach that detects multiple parameters of the virus can warrant such an accuracy.  With our RECOGNIZE test, we will achieve the lowest false negative rate so that asymptomatic patients would not be creating hot-spots for COVID.

Our solution is to develop robust, accurate and easy to use SARS-CoV-2 surveillance and diagnostics platform that can be easily incorporated in daily lives as self-test as well as mid- to high- throughput testing stations at any place that people congregate, such as workplaces, nursing homes, airports, etc.  Our platform will use synthetic molecular recognition sensors that have been pioneered by Prof. Strano at Massachusetts Institute of Technology and involves selection of a heteropolymer from a library followed by suspension with fluorescent nanoparticles, such that it creates a pinned configuration around the nanoparticles, referred to as the corona phase, enabling the exquisite selective recognition of a target analyte at a single molecule level and in real time. This synthetic molecular recognition overcomes several shortcomings of natural molecular recognitions (i.e., antibodies and oligonucleotides), including their lack of binding tunability, instability in harsh conditions, limited lifetime and their high cost.  Single-walled carbon nanotubes (SWCNTs) are used as the transducing fluorescent nanoparticles owing to their high photostability, lack of photobleaching, and bright fluorescent emission in the near-infrared (nIR) part of the spectrum, which overlaps with the tissue transparency window.  Furthermore, SWCNTs can be rendered biocompatible and thus used for in vivo applications.  

SARS-CoV-2 virus entered our world in late 2019 and soon after it became a pandemic, as of June 14, 2020, close to 8,000,000 people have been diagnosed and 433,904 patients have succumbed (Worldometer) to the disease caused by it, COVID-19. Respiratory infection with SARS-CoV-2 can become a medical emergency where rapid life-saving treatment and quarantine are critical.  While everyone appears to be infected the same ways through the nose or throat via virus-loaded droplets, most people with COVID-19 are asymptomatic or have mild symptoms.  These people are silent transmitters of this disease that can be deadly in people with predisposition, elderly and others with underlying diseases.   As this pandemic spread throughout our globe, shelter at home and quarantines became a way of our lives which results in a significant toll on the world economy as well as on physical and emotional well-being of our world.  Our solution can impact everyone globally by providing rapid, robust, accurate, and easy to use test for early detection of SARS-CoV2 infection.  This will allow triage, self-isolation or hospitalization and care of those who will become ill, and will provide a “New Normal” for the world and will save lives.

COVID-19 disease is the latest pandemic, impacting everyone’s lives globally.  COVID-19 is highly contagious and in order to avoid break points in healthcare systems and massive losses of lives, shelter-in-place orders were put in place around the world, affecting the global economy.  While our societies are opening up slowly with restrict social distancing and hygiene guidelines, we need to have a rapid, robust, accurate, easy to use and inexpensive test that can detect SARS-COV-2 infection very early.  RECOGNIZE will provide such a solution by using synthetic molecular recognition sensors with exquisite sensitivity, a real time detection at single molecule level.

RECOGNIZE is an innovative diagnostic platform that uses novel synthetic molecular recognition sensors for detection of target molecules.  These sensors get incorporated to off the shelf detection components for optical and electrochemical detection devices that are adaptable to single throughput for self-testing (i.e., glucometer), as well as a mid- or high-throughput devices for rapid testing at restaurants, universities, airports and other places that people congregate. The process from selection of the synthetic molecular sensors to building the detector can be carried out in 2-4 weeks for multiple targets in parallel.  Our RECOGNIZE-SARS-CoV-2 platform will be a multimodal diagnostics that will detect SARS-CoV-2 virus, viral proteins (N, S, M and E) and RNA sequences that are specific to SARS-CoV-2 with exquisite sensitivity at a single virus level an in real-time.   Synthetic molecular recognition sensors for SARS-CoV-2 will be selected from a library of heteropolymers followed by suspension with fluorescent nanoparticles, such that it creates a pinned configuration around the nanoparticles, enabling the selective recognition of a target analyte. This synthetic molecular recognition overcomes several shortcomings of natural molecular recognitions (i.e., antibodies, proteins and oligonucleotides), including their lack of binding tunability, instability in harsh conditions (temperature and chemical sensitivity) limited lifetime and their high cost.  Single-walled carbon nanotubes (SWCNTs) are used as the transducing fluorescent nanoparticles owing to their high photostability, lack of photobleaching, and bright fluorescent emission in the near-infrared (nIR) part of the spectrum, which overlaps with the tissue transparency window. 

Synthetic molecular recognition sensors were pioneered by Prof. Strano at MIT and coined as CoPhMoRe sensors.  This process involves selection of a heteropolymer from a library followed by suspension with fluorescent  nanoparticles, such that it creates a pinned configuration around the nanoparticles, referred to as the corona phase, enabling the selective recognition of a target analyte. This synthetic molecular recognitions overcomes several shortcomings of natural molecular recognitions (i.e., antibodies and oligonucleotides), including their lack of binding tunability, instability in harsh conditions, limited lifetime and their high cost and the length of time it takes to develop and validate antibodies.  Single-walled carbon nanotubes (SWCNTs) are used as the transducing fluorescent nanoparticles owing to their high photostability, lack of photobleaching, and bright fluorescent emission in the near-infrared part of the spectrum, which overlaps with the tissue transparency window.  

SWCNT CoPhMoRe detection platform whereby allows non-biological molecular recognition sites to be formed from an amphiphilic polymer and nanoparticle templates. Adsorption of the polymer onto the nanoparticle template creates a unique three-dimensional structure capable of molecular recognition. Sensor development involves the encapsulation of SWCNT samples with a library of polymer phases and subsequent screening of these corona phases against analytes. Molecular recognition involving interaction of an analyte with the polymer wrapping induces a fluorescence response of the underlying nanotube as reflected by a change in signal intensity or wavelength. Using this concept, we have developed sensors for a variety of molecule types working in a variety of environments, including whole blood, demonstrating their robustness.

Molecular recognition involving interaction of an analyte with the polymer wrapping induces a fluorescence response of the underlying nanotube as reflected by a change in signal intensity or wavelength. Using this concept, Prof. Strano's team have developed sensors for a variety of molecule types including Insulin, vitamins, steroids, carbohydrates, proteins, nucleic acids, neurotransmitters, small molecule pharmaceutical drugs, etc. These measurements have occurred in a variety of environments, including whole blood, buffer, cellular media, and inside of plants demonstrating their robustness.  One of the evidences for the utility of this technology is for Insulin detection using a CoPhMoRe sites on SWCNTs (Bisker, et 2018).  For this, a high-throughput screening of a library of polyethylene glycol-conjugated lipids were adsorbed onto near-infrared fluorescent SWCNTs to discover a corona phase selective for insulin. C16−PEG(2000 Da)−ceramide was found as a synthetic molecular sensor that selectively caused decrease in the fluorescent intensity and of the chirality nanotube in the presence of insulin. The insulin protein has no affinity toward the C16−PEG(2000 Da)−ceramide molecules in free solution, and the interaction occurs only upon their adsorption onto the SWCNT scaffolds. Testing a panel of proteins originating from human blood and short 7 amino acid fragments of the insulin peptide rules out nonselective recognition mechanisms.  These synthetic molecular sensors open up a new path for continuous monitoring of patients in vivo. 

Our mission is to develop the world’s most advanced and comprehensive precision diagnostic technology to impact the lives of people through early detection, surveillance and monitoring of disease in a rapid, robust, accurate and inexpensive manner.  We have the technical know-how and exclusive partnerships to rapidly develop and validate RECOGNIZE platform with our initial focus on the detection of SARS-CoV-2 in nasal or mouth mucus.  

Respiratory infection with SARS-CoV-2 can become a medical emergency where rapid life-saving treatment are critical. While everyone appears to be infected the same ways through the nose or throat via virus-loaded droplets, most people with COVID-19 are asymptomatic or have mild symptoms.  These people are silent transmitters of this disease. In Spring of 2020, as this pandemic spread throughout our globe, life as we know it stopped. Shelter in place and quarantines became a way of our lives which results in a significant toll on the world economy as well as on physical and emotional well-being of everyone.  One of the critical needs for a new global normal would require rapid, accurate and on-site tastings at any gathering place including work and educational places, airports, etc.  Currently, checking temperature is used as a proxy for infection, however, asymptomatic people and those with very early stage of the disease, while highly contagious, do not present a fever.   

Our goal is to develop and commercialize a multi-modal platform, RECOGNIZE, for detection of SARS-CoV-2.  The RECOGNIZE platform utilizes a high-throughput device for rapid and large screening options that can initially be CLIA approved for testing in clinical settings.  In order to expedite deployment to the field, we will incorporate our synthetic molecular recognition detectors into disposable, commercially available electrodes on OEM Instruments and partner with large diagnostic companies such as Roche or Abbot to reach everyone rapidly and globally. In addition, we plan to integrate our detectors into electrochemical detectors similar to a glucometer for self-testing.   Having such a test globally available, will create a new normal, where regular pre-screening for SARS-CoV-2 and perhaps other contagious diseases becomes a part of life before entrance to any congregational place.

SARS-CoV-2 is a new global threat with no robust and accurate solutions for its detection.  The current antibody tests to the viral particle are mostly antibodies that have been developed and studied over the last decade for other family members including SARS and MERS, hence their ineffectiveness for accurate testing. RT-PCR strategies require highly technical equipment and technologists and take time from specimen to result.  At the present, our technology is not serving people.  While the core technology is developed for many applications, and for detection of many other analytes/targets, including insulin, IL-6, fibronectin, nucleic acids, Nitrogen Oxide, miRNA; the synthetic molecular recognition sensors need to be screened and validated for each target.   RECOGNIZE for SARS-CoV-2 is being developed based on the urgent global need for surveillance, monitoring and diagnosis of people who are infected with SARS-CoV-2. Our goal is to have our RECOGNIZE platform launched within 12 month with a high-throughput as well as point-of-care/self-test.  Our rapid, robust, easy to use platform for detection of SARS-CoV-2 will allow our global communities to have “a safe new normal”.  A simple mouth swab can be placed on one end of the test strip to activate the electrochemical and/or photodetection of our each of our sensors with a software or an app analyzing and reporting the results of the SARS-CoV-2 test.  Our devices can be places at any places that people congregate such as workplaces; educational; hospitals; cultural, religious, tribal events; shopping places, etc.  

Our goals for the remainder of 2020 are A) to screen, identify and validate synthetic molecular recognition sensors for SARS-CoV-2, its structural proteins (N, S, E and M) and to viral RNA regions that are specific and selective for SARS-CoV-2; B)  design and build electrochemical and photo detectors as a orthogonal strategies to quantitate the sensors; C) carry out clinical validation of our detectors in a retrospective and prospective clinical trial using mouth and/or nasal swabs from healthy volunteers and well as volunteers who have tested positive for SARS-CoV-2 including those who are asymptomatic.  In 2021, we plan to  D) adopt our technology to commercially available medical devices that can be licenses and are based on electrochemical detection and photodetectors for a rapid; E) validate the platform and test for sensitivity, specificity, reproducibility, stability and ease of use F) obtain regulatory certifications such as EUA FDA, FDA, ISO13485;  F) Partner  with manufacturing for ramp up development of the adopted devices;  G) debut of initially our point of care device (a slightly modified glucometer) in the USA, EU and parts of Asia ; H) followed by regulatory approval in China through NMPA for manufacturing and debut in China.

At the present, our major barrier is adequate funding and strategic mentorship.  Our program is an academic, biotechnology collaboration and partnership. In our team, we have some of the most talented molecular and electrical engineers, virologist and clinician scientists.  Prof. Strano is the inventor of synthetic molecular sensors.  He and his team have been actively working on optimizing and perfecting this technology over the last decade with many publications in tier 1 journals and with several patents.  Applying the technology to multiple targets related to SARS-CoV-2 can be done in 2-4 weeks. And Dr. Furst had developed and advanced the technologies to rapidly build electrochemical detectors for these sensors.  Upon funding, we will retaine MPR associates Inc.  They are a team of engineers that assist companies take products from the prototype phase to development, manufacturing and debut without any interest in the intellectual property.  MPR associated also have experts in regulatory approval that we will be engaging early on to assisting our partners at the Mayo Clinic for the clinical validation and regulatory approval.  Our only barrier is getting adequate funding.   We are seeking funds through various government programs that have announced funding for SARS-CoV-2 and COVID-19 programs.  We are also in discussions with private funds. 

The platform that we are putting in practice globally for SARS-CoV-2 surveillance and diagnosis can be applied to any other disease or application that a well-established target is known.

We are submitting proposals for funding to RADx, BARDA, DARPA, AFX, and NIH.  These funding opportunities have rapid turn-around time for SARS-CoV-2 program.  Obtaining any of these funding will assist us in seeking private funding under better terms.  We have initiated the program with discretionary and partner funds at this point.

Engaging MPR associates will allow us to have a seamless progress without any delays as they are a leading engineering and technology consulting firm with over 50 years of expertise in sensor and detector technologies in the biomedical and other fields.  They will be providing program management, regulatory affairs, manufacturing expertise as well as expertise in any other area that we would require to develop our product into a robust, rapid, accurate, easy to use and regulatory approved biomedical device that can detect infection with SARS-CoV-2 at an early time point and to provide a new way of life in the era of SARS-CoV-2 pandemic and beyond.

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We are  molecular, chemical and electrical engineers in biotech, academia and engineering consulting firm. Dr. Khosravi-Far is the CTO with expertese in Precision Medicine, certificates in program in leadership development (HBS) regulatory and clinical trials (HMS).  Dr. Strano, MIT, is the inventor of synthetic molecular recognition sensors. Drs. Mukhophyay, and Iyer are Clinical Site PIs at the Mayo Clinic. MPR engineering consultants, integrate engineering, science and industrial design to excel new product development.   Dr. Dewar, a clinical pathologist and Dr. Nir, and Mr. Steinmiller are our board members and serial entrepreneurs with experience in diagnostic products.

The technology is based an invention by one of our academic collaborators, Dr. Strano at Massachusetts Institute of Technology. He has extensive work with carbon nanotube and holds a number of patents in this area. He has examined the surface chemistry of carbon nanotubes, and the relationship of surface chemistry to the semiconductive, metallic, and insulating properties of nanotubes. He is the inventor of nanostructure-based sensor and synthetic molecular recognition elements for selective and specific detection of biological macromolecules including proteins and nucleotides. In addition, Dr. Furst at MIT has expertise to develop these sensors into detectors.   InnoTech officers have expertise in precision diagnostics and have access to a CLIA lab to test and validate our RECOGNIZE-SARS-CoV-2 platform.  The Mayo Clinic will also carry out independent validation of the platform with independent cohorts.  InnoTech Health is also closely working with MPR associates Inc.  MPR associates integrate engineering, science and industrial design in a focused process to excel new product development assisting in bringing a concept to reality.  MPR associates have been successful to deliver products in as few as 8 months.  Jeffery Champagne is our Chief Advisor at MPR.   Jeff has helped many emerging technologies with their road maps and navigating obstacles to realize objectives and to speed up commercialization plans.    

Innotech is currently partnering with Massachusetts Institute of Technology (MIT) to develop the synthetic molecular recognition sensors for SARS-CoV-2 and transfer them to detectors.  Drs. Michael Strano, Ariel Furst and Anthony Sinskey and members of their teams are our collaborators at MIT.

Innotech is also partnering with the Mayo Clinic.  Dr. Roberto Cattaneo is an expert virologist who is advising us on the overall viral detection strategy.  Dr. Vivek Ayer is Clinical Site PI at the Mayo Clinic who will be leading the clinical trials at the Mayo and other sites.  He is the primary immune deficiency clinic at Mayo Clinic and serve as an interface between infectious disease and immunology.  He is a frontline clinician treating COVID-19 patients.   Finally, Dr. Debabrata Mukhupadhyay has expertise in therapeutics and diagnostics and well carry out independent validations of our sensors, detectors and final product.

Finally, MPR associates specialized in the development of new life sciences diagnostic systems and integrated medical devices.  Their product development team will be involved in project management, identification and testing of the diagnostic devices and partnership with manufacturing.  They will further assist us in regulatory matters and reimbursement issues.  

We are a pre-revenue, Massachusetts LLC company, developing liquid biopsy diagnostics for early-stage detection of disease with our initial focus on SARS-CoV-2/COVID detection. Our first asset is a mouth swab or breath test that with machine-learning predictive algorithm and a self-test diagnostic platform will determine the presence of the virus.  We are working with a multidisciplinary team from the Massachusetts Institute of Technology and the Mayo Clinic to rapidly develop diagnostics using synthetic molecular recognition sensors that can be used on a high-throughput OEM as well as a simple self-test diagnostic (similar to a glucometer with electrochemical detection).

Revenue and Exit Strategy: InnoTech plans to remain as a Research and Development company to bring highly innovative products to the market.  With our first SARS-CoV-2 detection and surveillance product launched by the end of 2020,  our SARS-CoV-2 platform will be target for acquisition by large diagnostic companies such as Roche and Abbott.  This will allow such companies with global resources to rapidly market and distribute our innovative product to all in need much more efficiently that InnoTech would be able to. 

InnoTech will then spin out other product sectors for diagnostics that predict COVID-19 severity,at the time of initial diagnosis of the infection, thereby allowing clinicians tools for timely and effective triage of the COVID-19 patients.  In addition, we plan to utilize the synthetic molecular recognition sensors for diagnostics for other infectious diseases as well as diagnostics for early detection of cancer. 

SARS-CoV-2 is a novel human coronavirus that started infecting humans in late 2019.  The World Health Organization declares the outbreak a pandemic on March 11, 2020.  Since then there have been many governmental programs in the USA, as part of CARES ACT and other programs, and around the world to support programs on development of diagnostics, vaccines and therapeutics.   At InnoTech, we are applying for such funds through various agencies, including Biomedical Advanced Research and Development (BARDA), Defense Advanced Research Projects Agency (DARPA), NIH RADx program and other funding agencies.  We are also utilizing discretionary and personal funds to screen for the synthetic molecular recognition sensors and detectors. We are also seeking SBA-7A debt funding to advance the program more rapidly. Finally, we are in discussions with private investors. Although, the current economic situation has created uncertainty in investments, we believe that having developed the synthetic molecular recognition sensors and detectors, and obtaining grant funding will allow us to have better investment terms.

InnoTech is applying to Solve to have access to peers, mentors and funders.  We have put together a multidisciplinary team of molecular, chemical and electrical engineers, clinician scientists and entrepreneurs with expertise in precision diagnostics.  Our major barrier is access to seed funding and business and strategic mentorship to get our development to reach a significant increase in valuation.  This will allow us to have the funds for rapid development, clinical testing, OEM or other device manufacturing and partnership with large diagnostic company for debut.  We believe that being part of the Solve family will provide us access to the right talent and valuable mentorship at every step of this process.

Being part of the Solve family will enable us to effectively prepare funding and revenue modes to be able to successfully and compete for funds.  Moreover, Solve will give us a much valued access to mentors, advisors, talents as well as board members who will guide as and partner with us in bringing RECOGNIZE to market and help humanity reach a new normal in the era of COVID-19 pandemic.  Solve will also provide us with monitoring and evaluation, as well as regulatory and legal advice to ensure that with such an important product and rapid timeline, our product will be to the best specifications and standard.  For a product to reach the intended target population effectively, marketing, media and exposure plays a significant role and Solve's global reach can ensure that our RECOGNIZE-SARS-CoV-2 diagnostics and surveillance can reach as many people for routine and daily screening.

While we have initiated partnerships with several members of Electrical Engineering faculty at MIT, including Professors Michael Strano, Ariel Furst and Anthony Sinskey, a formal interaction with their groups through Solve will be very valuable.  In addition, a partnership with MIT Sloan School of Management and entrepreneurship programs will be very valuable for the growth and success of InnoTech.  A partnership with Harvard-MIT Health Sciences and Technology Program will be invaluable for the multi-center clinical evaluation of RECOGNIZE. 

Our solution, RECOGNIZE, is a rapid response to the COVID-19 pandemic that has handicapped our world.  RECOGNIZE is an accurate, rapid and robust multi-modal platform for the detection of SARS-CoV-2 virus based on virus structural proteins and RNA using synthetic molecular recognition sensors that can be detected through both optical and electrochemical detectors. This orthogonal and integrated approach provides the highest possible sensitivity and specificity by recognizing multiple elements of SARS-CoV-2 in one rapid test.  In this platform, synthetic molecular recognition sensors to coronaviruses will detect the virus in liquid biopsy samples, such as mucus collected through mouth/nasal swabs, or exhaled breath and then synthetic molecular recognitions directed to specific RNA sequences in SARS-CoV-2 will determine the presence of this virus specifically.  For a large population testing, a test with greater than 99% accuracy would be ideal, an orthogonal approach that detects multiple parameters of the virus can warrant such an accuracy.  With our RECOGNIZE test, we will achieve the lowest false negative rate so that asymptomatic patients would not be creating hot-spots for COVID and our world can find a new normal through an accurate, easy-to-use and field adaptable platform designed for self-test as well as mid- and high- throughput testing.

While our RECOGNIZE surveillance and diagnosis platform for SARS-CoV-2 is a solution for a global pandemic and can benefit everyone, its ease of use and low cost can specially benefit women and girls.  In many third world countries, men have more access to medical care and could prevent women from such care.  Having a self-test as well as point-of-care solution would permit mobile medical, social or NGO's to provide the test to women to avoid the spread of SARS-CoV-2 among this at need population.  Even in the United States, the epidemiological reports indicate that minorities have a higher death rate presumably due to lack of access to medical care and testing.

While our RECOGNIZE surveillance and diagnosis platform for SARS-CoV-2 is a solution for a global pandemic and can benefit everyone, its ease of use and low cost can specially benefit refugees.  Refugees are at-risk population, who live in congregational camps and simple measures such as physical distancing, regular hand washing could be very limited or not possible.  A rapid, low-cost and easy to use test that can be supplied to the NGOs and other groups managing the refugee camps, can provide a tool for regular testing to surveillance and selective isolation and to prevent hot spots for SARS-CoV-2 infection in refugee camps.    Even in the United States, the epidemiological reports indicate that people in congregational locations such as nursing homes have a higher death rate presumably due to inability to physically distance properly.