RAPIDx

InnoTech Precision Medicine, through its RAPIDx Diagnostic Platform, identifies a pressing issue in women's healthcare: the lack of convenient, accurate, and timely diagnostic testing for infections of the female reproductive system and their antimicrobial resistance. This deficiency leads to significant challenges in diagnosing and treating conditions such as urinary tract infections (UTIs) and sexually transmitted infections (STIs), which affect millions of women worldwide.

UTIs, caused by bacteria such as Escherichia coli and Klebsiella pneumonia, have seen a concerning increase in antimicrobial resistance in recent years. This rise complicates treatment and can result in severe consequences, including kidney damage and life-threatening urosepsis. Similarly, STIs like gonorrhea and chlamydia present significant health risks if left untreated, including infertility and increased susceptibility to other infections.

The current diagnostic process for these infections relies heavily on clinical symptoms and laboratory testing conducted in centralized facilities. However, this approach has several limitations. Firstly, it often involves lengthy turnaround times, with results taking days. This delay can lead to delayed treatment initiation, allowing infections to progress and cause further harm. Additionally, centralized testing facilities may not be easily accessible to all patients, particularly those in rural or underserved areas.

Furthermore, the reliance on clinical symptoms for diagnosis introduces a degree of uncertainty, as symptoms of UTIs and STIs can overlap with other conditions. This ambiguity can result in misdiagnosis and inappropriate treatment, further exacerbating the problem of antimicrobial resistance.

The lack of accessible and accurate diagnostic testing disproportionately affects vulnerable populations, including women from low-income backgrounds and marginalized communities. These individuals may face barriers to accessing healthcare services, leading to disparities in health outcomes and exacerbating existing inequalities.

Moreover, the economic burden associated with delayed or incorrect diagnosis and treatment is substantial. Hospitalizations, loss of income due to illness, and expenses related to complications from untreated infections all contribute to the financial strain experienced by affected individuals and healthcare systems.

In summary, the current state of diagnostic testing for infections of the female reproductive system falls short in several key areas. Delays in diagnosis, uncertainty in clinical assessment, and limited accessibility to testing facilities hinder efforts to effectively manage these conditions and mitigate the growing threat of antimicrobial resistance.

Addressing these challenges requires innovative solutions that prioritize accessibility, accuracy, and timeliness in diagnostic testing. By focusing on the underlying problem of inadequate diagnostic capabilities, stakeholders can work towards developing sustainable and equitable healthcare solutions that benefit all women, regardless of their geographic location or socioeconomic status.

InnoTech is developing and commercializing an innovative diagnostic platform technology, RAPIDx, aimed at tackling the daunting challenges in diagnosing infections of the female reproductive system and antimicrobial resistance (AMR). This groundbreaking solution offers a highly sophisticated and multiplexed capability, enabling the simultaneous detection of up to 96 biomarkers, including nucleic acids and proteins, in an easily deployable and ultra-portable medical device, and easy to use all-enclosed microfluidic cartridge format that provides specimen to results in 30 minutes or less.

The cornerstone of RAPIDx's success lies in its state-of-the-art chemistry and engineering, which facilitate rapid and accurate detection of pathogens and AMR markers. Harnessing proprietary technology, RAPIDx utilizes easily collectable specimens to deliver results comparable to lab-based PCR and ELISA assays, all achieved within a swift 30-minute window from specimen to results. This rapid turnaround time is critical for prompt initiation of treatment, averting disease progression, and mitigating the risk of complications.

Key technical features of RAPIDx include its user-friendly interface, unparalleled portability, and advanced bioinformatics tools. Engineered for near-patient use, the platform ensures accessibility and convenience for patients, even in remote settings. The microfluidic cartridge comes pre-loaded with long-lasting lyophilized reagents, eliminating the need for refrigeration and ensuring stability during storage and transportation. Furthermore, RAPIDx's modular design allows for flexible testing options, empowering healthcare providers to conduct assays for UTIs, STIs, and AMR either collectively or individually.

RAPIDx's innovative attributes contribute to its potential success in revolutionizing diagnostic testing for female reproductive infections and AMR. The plug-and-play chemistry and microfluidic cartridge facilitate rapid development and validation of assays for various pathogens and disease biomarkers. With its swift and accurate results, coupled with its near-patient testing capability, RAPIDx offers significant advantages, including expedited turnaround times, enhanced accessibility, and cost efficiencies compared to traditional laboratory-based testing.

In summary, InnoTech's RAPIDx Diagnostic Platform signifies a paradigm shift in infectious disease diagnostics, delivering a comprehensive and user-friendly solution for detecting UTIs, STIs, and AMR. By leveraging cutting-edge technology and innovative engineering, RAPIDx empowers healthcare providers and patients alike to make informed treatment decisions promptly, thereby improving patient outcomes and alleviating the burden of female reproductive infections and AMR and beyond.

Our solution, the RAPIDx Diagnostic Platform, serves as a crucial tool for addressing the healthcare needs of rural and low- to middle-income communities (LMICs), and disadvantaged populations with limited access to healthcare. Here's how our solution impacts their lives:

Healthcare Providers in Rural and LMIC Settings:

Improved Diagnostic Capabilities: Healthcare providers in rural and LMIC settings often face challenges in accessing sophisticated diagnostic tools. RAPIDx enhances its diagnostic capabilities by providing a comprehensive and rapid testing solution that detects multiple pathogens and antimicrobial resistance markers simultaneously.

Empowerment Through Technology: The platform empowers healthcare providers to deliver quality care even in resource-constrained environments, enabling them to make timely treatment decisions and improve patient outcomes.

Capacity Building: By introducing advanced diagnostic technology to rural and LMIC healthcare settings, RAPIDx contributes to capacity-building efforts, strengthening local healthcare systems, and enhancing the quality of care available to communities.

Patients in Rural and Disadvantaged Communities:

Accessible Healthcare: For patients in rural and disadvantaged communities, accessing healthcare services can be challenging due to geographic barriers, financial constraints, and limited infrastructure. RAPIDx brings diagnostic testing directly to these communities, offering near-patient testing solutions that eliminate the need for extensive travel and long wait times.

Timely Diagnosis and Treatment: By providing rapid test results within 30 minutes, RAPIDx enables patients to receive timely diagnoses and initiate treatment promptly. This is particularly crucial for individuals living in remote areas, where access to healthcare facilities may be limited.

Reduced Health Disparities: The accessibility and affordability of RAPIDx help reduce health disparities by ensuring that underserved populations have access to high-quality diagnostic services, regardless of their geographic location or socioeconomic status.

Communities Facing Healthcare Inequities:

Equitable Access to Healthcare: RAPIDx promotes health equity by breaking down barriers to healthcare access and ensuring that marginalized communities receive the same level of diagnostic care as more privileged populations. This is essential for addressing healthcare inequities and promoting social justice.

Disease Control and Prevention: By enabling early detection and treatment of infections, RAPIDx contributes to disease control and prevention efforts within communities, reducing the spread of infectious diseases and antimicrobial resistance.

Community Empowerment: The availability of RAPIDx in rural and disadvantaged communities empowers individuals to take control of their health and well-being, fostering a sense of community empowerment and resilience.

Overall, RAPIDx plays a critical role in improving healthcare access, enhancing diagnostic capabilities, and promoting health equity in rural and LMIC settings, and among disadvantaged populations with limited access to healthcare. By leveraging technology to bridge the gap between communities and healthcare services, RAPIDx facilitates early diagnosis, timely treatment, and better health outcomes for all.

InnoTech Precision Medicine's RAPIDx Diagnostic Platform represents a groundbreaking advancement in diagnostic testing, offering a highly innovative approach to addressing the challenges of detecting infections of the female reproductive system and antimicrobial resistance. Here's what sets our solution apart:

1. Multiplexed, rapid, and accurate testing: Unlike traditional diagnostic methods that often involve multiple tests and lengthy turnaround times, our platform enables simultaneous detection of up to 96 biomarkers, providing comprehensive insights into infections and antimicrobial resistance profiles in just 30 minutes. This rapid and accurate testing streamlines the diagnostic process, facilitating timely treatment initiation and improved health outcomes.

2. Novel chemistry and technology: InnoTech has developed proprietary chemistry and microfluidic cartridge technology that enables direct detection of pathogens and biomarkers from crude extracts, eliminating the need for complex sample preparation steps. Our chemistry, based on recombinase polymerase amplification (RPA) and exonuclease assays, offers sensitivity and specificity comparable to lab-based PCR and ELISA assays but in a portable and user-friendly format.

3. Accessibility and portability: By enabling near-patient testing with an all-enclosed microfluidic cartridge and ultraportable reader device, our solution brings diagnostic testing directly to the point of care, whether in healthcare facilities, pharmacies, or even the patient's home. This accessibility and portability empower individuals to take control of their health and access timely diagnostics regardless of their location or socioeconomic status.

4. Modular and scalable design: Our platform's modular design allows for flexible testing options, accommodating a wide range of pathogens and biomarkers associated with infections of the female reproductive system and antimicrobial resistance. Moreover, our technology can be easily adapted to detect other indications requiring gene, protein, epigenetic, or microbiome biomarkers, offering scalability and versatility in addressing diverse healthcare needs.

5. Potential for broader positive impacts: By revolutionizing diagnostic testing for infections and antimicrobial resistance, our solution has the potential to catalyze broader positive impacts in the healthcare space. Improved diagnostics can lead to more targeted and effective treatments, reducing the overuse of antibiotics and the emergence of drug-resistant pathogens. Additionally, early detection of infections can prevent complications, reduce healthcare costs, and enhance overall public health outcomes.

6. Market and landscape transformation: InnoTech's RAPIDx Diagnostic Platform has the potential to disrupt the diagnostic testing market by offering a cost-effective, rapid, and user-friendly alternative to traditional laboratory-based methods. By providing a comprehensive solution for infections of the female reproductive system and antimicrobial resistance, our platform could change the landscape of women's health diagnostics, driving innovation and improving access to care globally.

Thus, InnoTech's innovative approach to diagnostic testing has the potential to revolutionize healthcare delivery, improve patient outcomes, and catalyze positive impacts across the healthcare ecosystem.

Our RAPIDx Diagnostic Platform is designed to address the urgent need for rapid, accurate, and accessible testing for infections of the female reproductive system and antimicrobial resistance. Here's how we expect our solution to have an impact on the problem:

1. Activities: We will develop and commercialize our innovative diagnostic platform technology, leveraging our patented chemistry and microfluidic cartridge design. This will involve extensive research, development, and testing to ensure the effectiveness and reliability of our solution.

2. Outputs: The outputs of our activities include the completion of prototype development, obtaining regulatory approvals, and establishing partnerships for distribution and implementation. We will also conduct pilot studies to validate the effectiveness of our platform in clinical settings.

3. Immediate Outcomes: By providing rapid and accurate diagnostic testing, our solution will enable timely detection of infections of the female reproductive system and antimicrobial resistance. This will lead to faster initiation of appropriate treatment, reducing the risk of complications and improving health outcomes for patients.

4. Longer-Term Outcomes: As our solution becomes widely adopted, we expect to see several longer-term outcomes:

   • Reduced healthcare costs: Early detection and treatment of infections can prevent complications and reduce the need for expensive interventions such as hospitalization.
   • Decreased antimicrobial resistance: By guiding appropriate antibiotic use, our solution can help mitigate the development of antimicrobial resistance, preserving the effectiveness of existing antibiotics.
   • Improved access to healthcare: Our portable and user-friendly diagnostic platform can be deployed in various settings, including underserved communities and low-resource settings, improving access to timely diagnostics and treatment.
   • Enhanced public health outcomes: By preventing the spread of infections and reducing the burden of antimicrobial resistance, our solution can contribute to improved public health at the community and population levels.

5. Evidence: We will gather evidence to support the effectiveness of our solution through rigorous testing and evaluation in clinical settings. This may include data on diagnostic accuracy, treatment outcomes, healthcare utilization, and patient satisfaction. Additionally, we will seek feedback from healthcare providers and patients to ensure that our solution meets their needs and preferences.

Our impact goals for the RAPIDx Diagnostic Platform are focused on improving health outcomes, reducing healthcare costs, and combating antimicrobial resistance. Here are our specific impact goals and how we are measuring our progress toward them:

1. Improving Health Outcomes: Our primary goal is to improve health outcomes by enabling timely detection and treatment of infections of the female reproductive system and antimicrobial resistance. To measure our progress towards this goal, we are tracking indicators such as:

   • Reduction in the incidence of severe complications associated with untreated infections.
   • Improvement in patient-reported outcomes, such as symptom resolution and quality of life.
   • Increase in the proportion of patients receiving appropriate treatment within a clinically relevant timeframe.

2. Reducing Healthcare Costs: We aim to reduce healthcare costs by preventing unnecessary hospitalizations and interventions through early detection and targeted treatment. We are measuring our progress through indicators such as:

   • Reduction in healthcare utilization related to complications of untreated infections.
   • Decrease in the use of broad-spectrum antibiotics and other costly interventions due to improved diagnostic accuracy.
   • Cost savings for healthcare systems and payers are attributable to the implementation of our diagnostic platform.

3. Combating Antimicrobial Resistance: Our solution also aims to combat antimicrobial resistance by guiding appropriate antibiotic use and reducing the overuse of antibiotics. To measure our progress, we are tracking indicators such as:

   • Reduction in the prevalence of antimicrobial-resistant pathogens in communities where our diagnostic platform is implemented.
   • Decrease in the incidence of treatment failure and recurrence of infections due to targeted antibiotic therapy.
   • Improvement in antimicrobial stewardship practices among healthcare providers and institutions adopting our solution.

In addition to these impact goals, we are also monitoring other relevant indicators, such as access to diagnostics in underserved communities, patient satisfaction with the testing experience, and adoption rates of our platform by healthcare providers.

By measuring our progress against these impact goals and indicators, we can assess the effectiveness of our solution in creating positive and transformative changes in healthcare delivery, patient outcomes, and the fight against antimicrobial resistance.

The core technology powering our solution, the RAPIDx Diagnostic Platform, is a combination of innovative chemistry, microfluidics, and artificial intelligence (AI). Here's how each component contributes to the effectiveness of our solution:

Innovative Chemistry: Our platform utilizes proprietary chemistry that enables the direct detection of pathogens and biomarkers from crude extracts, eliminating the need for complex sample preparation steps. The chemistry is based on recombinase polymerase amplification (RPA) combined with an exonuclease assay, providing sensitivity and specificity comparable to lab-based PCR and ELISA assays. This innovative chemistry allows for rapid and accurate testing of infections and antimicrobial resistance in just 30 minutes.

Microfluidic Cartridge Technology: The microfluidic cartridge is a key component of our solution, housing all the necessary reagents and components for conducting the diagnostic tests. The cartridge is pre-filled with long-lasting lyophilized reagents, making it shelf-stable and eliminating the need for refrigeration. The cartridge design allows for multiplexed testing, with the capacity to detect up to 96 biomarkers simultaneously. Each cartridge contains spatially separated microfluidic wells, enabling the detection of multiple disease biomarkers in a single test.

Artificial Intelligence (AI): Our platform incorporates AI algorithms for data analysis and interpretation. The AI-enabled software analyzes the data generated from the diagnostic tests, providing rapid and accurate results to healthcare providers and patients. The AI algorithms analyze the data points and provide the results for each biomarker. Our second algorithm is trained to identify patterns and correlations within the test results, providing decisions about the status of the disease biomarkers and assisting in the diagnosis of infections and antimicrobial resistance. Additionally, the software is user-friendly, with a simple interface allowing for easy interpretation of the results.

The integration of innovative chemistry, microfluidics, and AI technology allows our RAPIDx Diagnostic Platform to deliver rapid, accurate, and accessible testing for infections of the female reproductive system and antimicrobial resistance. This core technology enables our solution to address critical healthcare challenges and improve health outcomes for individuals worldwide.

Our technology is a patented technology (US20220088584A1)

https://patents.google.com/pat...

Our technology has undergone rigorous testing and validation to ensure its accuracy and effectiveness. With RADx-RAD funding from the NIH (1R42DE030829 and 1R42DE030829-1S), we have conducted proof-of-concept studies in simulated patient specimens for several indications, demonstrating the capability of our platform to detect pathogens and biomarkers with high-sensitivity and specificity.

Additionally, we are currently carrying out analytical validation of our version-one medical device. This validation process involves testing the performance characteristics of our technology using standardized protocols and controls to ensure its reliability and consistency.

Furthermore, we are in the process of obtaining Institutional Review Board (IRB) approval to conduct pilot studies in clinical settings. These studies will involve testing our technology on actual patient samples to further validate its performance in real-world scenarios.

While we do not have publicly available academic papers at this time, we are committed to transparency and will publish our findings in peer-reviewed journals as soon as they become available. In the meantime, we are happy to provide detailed documentation and information about our validation process upon request.

Currently, our solution team consists of:

• Full-time staff: 4 members
• Part-time staff: 1 members
• Contractors or other workers: 5 members

Our 4 founding team members have over 100 years of experience in translational medicine, product engineering, product development, and commercialization. We have been working together on this solution for 3 years.

At InnoTech Precision Medicine, we prioritize diversity, equity, and inclusion (DEI) within our team and throughout our organization. We believe that fostering a diverse and inclusive environment not only strengthens our team but also enhances our ability to innovate and address complex challenges effectively.

Our commitment to DEI is reflected in several key aspects of our team culture and practices:

1. Diverse Leadership: Our leadership team is intentionally diverse, comprising individuals from different backgrounds, experiences, and identities. Two of the cofounders are immigrants and one is first generation. Our CEO is female. Among our staff, we have two immigrants and a woman. We recognize the importance of diverse perspectives in decision-making and strategy development, and we actively seek to include voices from underrepresented groups in leadership roles.

2. Recruitment and Hiring Practices: We have implemented inclusive recruitment and hiring practices to attract candidates from diverse backgrounds. We actively source candidates from diverse talent pools, utilize blind resume screening to mitigate unconscious bias, and ensure that our hiring panels are diverse and inclusive.

3. Regular Feedback and Evaluation: We regularly solicit feedback from team members through one-on-one conversations to assess our progress on DEI initiatives and identify areas for improvement. This feedback informs our ongoing efforts to create a more inclusive workplace culture.

By prioritizing diversity, equity, and inclusion within our team, we aim to create a work environment where all team members feel valued, respected, and empowered to contribute their unique perspectives and talents toward our shared mission of advancing precision medicine for all.

Our business model at InnoTech Precision Medicine is designed to deliver value not only to healthcare providers and patients but also to underserved populations in the USA and globally. Here's how we integrate social impact into our approach:

1. Products and Services: We offer the RAPIDx Diagnostic Platform, a groundbreaking solution for rapid and accurate testing of infectious diseases and antimicrobial resistance. Our platform is tailored to meet the needs of both traditional healthcare settings and underserved communities, providing accessible and reliable diagnostic testing options.

2. Target Customers and Beneficiaries: While our primary customers are healthcare providers such as clinics, hospitals, pharmacies, and NGOs our solution directly benefits underserved populations who often face barriers to accessing quality healthcare. By bringing diagnostic testing directly to these communities, we empower individuals to take control of their health and receive timely interventions when needed.

3. Value Proposition: For healthcare providers, our solution offers the ability to perform multiplexed testing for infections and antimicrobial resistance in a rapid, accurate, and cost-effective manner. This enables timely diagnosis and treatment decisions, ultimately leading to improved patient care and outcomes. For underserved populations, our platform represents a critical lifeline, providing access to essential diagnostic services, through mobile clinics, that may otherwise be out of reach.

4. Revenue Streams: While our revenue primarily comes from the sale of our diagnostic platform and associated consumables to healthcare providers, we are committed to ensuring that our solution remains accessible to underserved populations. We may explore alternative pricing models, subsidies, or partnerships with NGOs and governmental agencies to facilitate affordable access to our testing services in low-resource settings.

5. Distribution Channels: We distribute our products and services through direct sales channels, leveraging our sales team to engage with healthcare providers and institutions. Additionally, we may collaborate with local organizations, community health centers, and international partners to reach underserved populations and ensure equitable distribution of our diagnostic solutions.

By incorporating social impact into our business model, we aim to not only drive financial sustainability but also make meaningful contributions to public health by serving those who are most in need.

At InnoTech Precision Medicine, we are committed to achieving financial sustainability while fulfilling our mission of advancing precision medicine and improving healthcare outcomes for underserved populations. To accomplish this, we have developed a multi-faceted business model that leverages both social enterprise principles and traditional revenue-generating strategies.

Our plan for financial sustainability includes the following key components:

1. Revenue Generation through Product Sales: Our primary source of revenue comes from selling our RAPIDx Diagnostic Platform and associated consumables to healthcare providers, clinics, hospitals, and pharmacies. By offering a cutting-edge diagnostic solution that addresses critical healthcare challenges, we aim to capture market demand and generate sustainable revenue streams.

2. Service Contracts and Partnerships: In addition to product sales, we seek to secure service contracts and strategic partnerships with governments, healthcare systems, and NGOs. These collaborations may involve providing diagnostic testing services, implementing population health initiatives, or conducting research and development projects. By diversifying our revenue streams and tapping into various funding sources, we mitigate financial risks and enhance our sustainability.

3. Grants and Impact Investments: While revenue generation is a primary focus, we also actively pursue grants, impact investments, and philanthropic funding opportunities to support specific projects, research endeavors, and initiatives aligned with our mission. These funding sources enable us to expand our reach, invest in innovation, and pursue high-impact opportunities that may not be immediately financially lucrative but contribute to our long-term goals.

4. Social Enterprise Integration: As a social enterprise, we are deeply committed to reinvesting profits back into our mission and operations. By aligning our financial goals with our social impact objectives, we ensure that every dollar earned contributes to advancing precision medicine, improving healthcare access, and addressing disparities in underserved communities.

Evidence of Success:

To date, we have secured several grants and research funding awards from government agencies, foundations, and academic institutions to support the development and validation of our diagnostic platform. Additionally, we have established partnerships with healthcare providers and institutions for pilot testing and implementation of our technology in clinical settings.

Furthermore, our engagement with investors and impact investors has yielded seed funding and strategic investments to fuel our growth and scale our operations. These financial resources have enabled us to advance our research and development efforts, expand our product portfolio, and accelerate our go-to-market strategy.

In summary, our business model for financial sustainability integrates social enterprise principles with revenue-generating strategies to ensure long-term viability and impact. We remain committed to transparent reporting and accountability, providing stakeholders with evidence of our success in achieving both financial and social objectives.