AGED Diagnostics

Liver disease is the fastest growing epidemic in developed nations, affecting 1 in 3 Americans, or 100 million people in the US. While 80 million patients have simple steatosis (the benign form of liver disease), 20 million patients have nonalcoholic steatohepatitis or NASH (the advanced form) that can lead to liver related mortality, liver cancer and cardiovascular disease. The challenge for physicians is that there are zero noninvasive diagnostic tools, neither imaging nor biomarkers(s) that can differentiate those with benign from advanced liver disease.

AGED Diagnostics is using genomic innovation to develop the most accurate blood test for liver disease. Our efforts will provide physicians a noninvasive tool to improve patient outcomes, reduce the financial burden on health insurers and save lives by increasing the number of patients who are diagnosed at an early stage for early detection and intervention.

There are 100 million patients in the US who require routine screening for liver disease and these numbers are projected to rise in the coming decade as obesity and diabetes rates soar. US health insurers currently spend $108 Billion on annual management for liver disease and an additional $184 Billion annual costs as a societal burden, which is calculated by assigning a monetary value to quality of life-years lost due to liver disease.

Liver disease is one of the most common chronic disorders worldwide. There are zero non-invasive diagnostic tests for liver disease and due to this, liver disease is often undetected until patients have progressed to later stages which causes haptic and cardiovascular manifestations such as liver disease, heart disease, stroke and hypertension.

While liver disease is not the root cause of pandemics, the detrimental effects of undiagnosed liver disease directly contribute to heart disease and leave a nation of unaware “high-risk” individuals in the face of a pandemic. AGED Diagnostic is developing an accurate and non-invasive tool for liver disease, our efforts will enable early detection and intervention, increase access to true healthcare status and support a healthier, more informed patient population during the current and next pandemic.

When diagnosing liver disease two diagnostic assessments must be considered: first, is degree of fibrosis (liver scarring), as fibrosis accelerates liver related mortality (death). Second, is the ability to differentiate benign liver disease from NASH (advanced liver disease). Identifying both fibrosis and diagnosing advanced liver disease are essential to an accurate and early diagnosis.

AGED technology targets two types of biomarkers in circulation, liver damage markers and advanced liver disease markers. Both liver damage markers and advanced disease markers have a unique genetic signature. Our technology uses genomic innovation to determine the concentration of these genetic signatures (or biomarkers) in a patient blood sample. The presence of these genetic signatures (or biomarkers) past a defined concentration indicates that the patient has advanced liver disease.

AGED’s competitive advantage is that our technology would be more accurate than all other alternatives, less expensive than the gold standard (liver biopsies) and be able to both stage of fibrosis and differentiate benign from advanced liver disease.

At AGED, we have spoken to more than 400+ key stakeholders including gastroentologists, hepatologists, cardiologists, surgeons, and health insurers among many others. Through these interviews we have learned that a hidden mechanism of healthcare inequality is physical access into the clinical. Since liver biopsies are the only effective tool for diagnosing NASH (advanced liver disease), this creates a physical barrier for patients to obtain proper care. Liver biopsies are time intensive: a patient must take the day off work to have a biopsy performed, and afterwards recovery can take between 2-5 days before patients can return to routine tasks (such as bathing, lifting heavy objects and in certain cases returning to work). Patients of lower socioeconomic status are more likely to drop out of monitoring programs due to unrealistic expectations required for adequate detection of NASH. Today, there are zero noninvasive diagnostic tools to detect NASH.

AGED Diagnostics aims to take a patient first approach by developing the most accurate non-invasive tool for NASH. Our efforts will break socioeconomic barriers through intentional inclusion of patients by providing a service that is non-invasive, fast, accurate and does not impede on their work day. Our efforts will enable physicians to keep patients in the monitoring programs for the earliest detection of NASH to evade both hepatic and cardiovascular complications.

If infected, certain groups of people are higher-risk for complications from Sars-COV-2 (or COVID19). Liver disease directly contributes to these high-risk factors such as cirrhosis, liver cancer, hypertension, stroke and cardiovascular disease. Liver disease is asymptomatic until later stages. AGED solution can determine which of the 100 million people in the US have the progressive form of liver disease (which is revisable if treated), our efforts would enable early detection and intervention so patients can become healthier in a typical society and well informed of their true health status in the face of the current and next pandemic.

AGED has identified a list of candidate genetic biomarkers that can differentiate the benign form of liver disease from the advanced form of liver disease. We have analyzed about 100 patient liver tissue samples and used computational assessment to determine the best candidate biomarkers. 

AGED is closing on a seed round next month (July) to initiate a pilot study with a contract research organization (GeneWiz, located in Plainfield, NJ) to assess the validity of our target biomarkers in 50 patient blood samples. Upon completion of this pilot study, we will expand sample size and conduct a clinical trial with our collaborator Dr. Coleman Irving Smith, MD (Transplant Hepatologist) at Georgetown University Hospital (Washington, DC).

AGED innovation analyzes genomic modifications that regulate gene expression. The challenge with other diagnostic serum (blood) tests on the market is that they utilize genes or proteins that are often found in other types of liver disease, as well as the benign form of liver disease. AGED solution alleviates these challenges by using advanced bioinformatics tools to select for the most reliable genomic regions associated with liver disease. Our target genomic regions are far superior to using genes or proteins to assess disease status and AGED is pioneering this emerging branch of genetics to develop diagnostic tools with superior clinical utility over current and emerging markers.

AGED innovation has two core assessments, first, is degree of fibrosis (liver scarring), as fibrosis accelerates liver related mortality. Second, is the ability to differentiate simple steatosis (benign) from NASH (advanced liver disease).

AGED competitive advantage is that we would be the only non-invasive diagnostic tool that can stage fibrosis, and diagnose NASH, and simultaneously pursue these aspects while excluding other forms of liver disease. To date, zero blood tests can differentiate benign from advanced live disease.

AGED plans to be the first to market to leverage targeted genomic sequencing in peripheral blood. Our methods will enable a non-invasive and accurate diagnostic test that can diagnose patients at an early stage for early detection and intervention. In addition, our methods also have a broader positive impact in the medical community, as our technology can be used to diagnose other diseases and cancers.

Currently: AGED Diagnostics Multiple Target Assay is currently in development. In the US there are 100 million patients who have NAFLD (benign form of liver disease) and over the next 15 years AGED seeks to capture 25% of the US market or 25 million patients. Currently, AGED seeks to deploy adequate research and development over the next 18 months and launch our diagnostic assay by January 2023.

One and a Half Years: By 2023 AGED seeks to deploy our diagnostic assay through several pilot programs in the Washington DC and Maryland area with partner hospitals such as MedStar Georgetown. In 2023, we seek to capture 0.1% of our target market or 25,000 patients, to reach this goal we will need to engage 15+ hepatologists (as each physician monitors 1,500 high risk patients for NASH each year).

Five Years: By 2026 AGED seeks to capture 5% of our target market or 1.25 million patients annually. To reach this goal, we will need to engage 750 hepatologists.

The majority of patients diagnosed with liver disease are diagnosed when they have progressed to advanced NASH, cirrhosis (advanced fibrosis) and are in need of a liver transplant, and at this time liver related mortality is known to increase by 50-80%. Early stage detection is the only time when liver disease can be curative. AGED Diagnostics tool will enable patients with diabetes, obesity and metabolic syndrome to be appropriately monitored for NASH. AGED will measure impact by enumerating the increase in early detection, increase in patients who attain medical intervention and treatment, and a decrease in overall mortality rates from liver disease.

Individuals of lower socioeconomic status and individuals of Latin American and African backgrounds in the US are known to have poorer clinical outcomes for liver disease and higher rates of mortality as compared to Caucasian counterparts. These disparities are in part due to the fact that there are physical barriers to obtain diagnoses, such as the time intensive, invasive and expensive nature of liver biopsies. AGEDs mission is to alleviate disparities to ensure that ethnicity and socioeconomic status are not contributing factors to disparate rates of liver disease. We will measure our impact by enumerating patients access with a keen focus in hard hit disparate cities in the US. In addition, as part of our mission AGED seeks to engage patients of various ethnicities during our clinical trials to ensure that patients of all backgrounds are appropriately accounted for in biomarker development.

Full Time: 2

Part Time: 5

Contractors: 3

Advisors/Equity Share Holders: 5 Total: 15

We have leading experts in genetics, bioinformatics, transplant hepatology and business.

AGED Core Team:

Rachel Zayas, AGED Founder/CEO, has a Masters in Biotechnology and Business, previously launched a biotech venture and worked at MIT in cancer research (at the Koch Institute) developing gene silencing therapeutics. Zayas is a fellow for Healthworx, published in the leading medical journal for liver disease and presented work at the annual liver disease conference.

Dr. Marius Nagalo, AGED Director of Scientific Innovation, Professor of Medical Oncology and Virologist at Mayo Clinic, Arizona. At AGED, Dr. Nagalo supports our R&D efforts, drafting grants, clinical validation, speaking at conferences and engaging key partners. 

Dr. Bongsoo Park, AGED Lead Bioinformaticist consults as a NIH Bioinformaticist and Lectures at John Hopkins University. Dr. Park executes AGED bioinformatics pipeline, utilizing diverse bioinformatics tools and machine learning techniques for the identification of candidate biomarkers.

Dr. Coleman Irving Smith MD, AGED Clinical Advisor, Dr. Smith is a Transplant Hepatologist at MedStar Georgetown Transplant Institute and is a Professor of Medicine at Georgetown University School of Medicine. Dr. Smith serves as AGED clinical advisor, designing experiments and clinician validation of AGED’s diagnostic assays.

AGED Advisors:

Dr. Kenneth Buetow, Past Director of Bioinformatics at NIH.

Dr. Justin Topp, past professor of Biotechnology and genomics expert at Integrated DNA Technology.

Dr. Robert Lewis, MD/PhD, Gastroenterology/Hematology, Professor of Medicine at Mayo Clinic.

Greg Miller, Past Senior VP of Finance at Marriott International Dave McCarthy, Professor of Business George Washington University, Angel Investor.

Each member on the AGED executive team is either a personal of color, female or immigrant to the United States, we value diversity, inclusion and seek to create an equitable leadership team to reflect the communities we serve.

AGED Founder/CEO, Zayas, is a female technology founder, she is also a Jewish American and has experienced first-hand the importance of inclusion, equality and embracing differences as a form of strength in her community.

Dr. Marius Nagalo was born and raised in Burkina Faso, Africa and brings with him the experience of growing up in a developing nation where access to healthcare and early intervention were often scare. Africa has the highest rates of global liver related mortality and Dr. Nagalo brings these experience as a means of grit and perseverance to address these global challenges. Dr. Nagalo has lead various research teams to Burkina Faso to study and develop solutions to various forms of liver disease and healthcare inequality in African including a keen focus on viral hepatitis and HIV.

Dr. Bongsoo Park is an immigrant from South Korea and Dr. Coleman Smith grew up in Australia. Our team values diversity as a form of strength and as we grow, we seek to hire more executives who identify as LBGTQ+, female as well as members of various ethnic and religious backgrounds in order to continue to foster a leadership team dedicated to diversity, equity and inclusion.

Through MIT Solve we can facilitate early detection and intervention of liver disease to advance positive patient outcomes and improve overall patient health for high-risk patients of current and emerging pandemics

My primary goal of applying to MIT Solve is to become part of a community of innovators and entrepreneurs that show up every day yearning for progress. I have always had a love of learning and with that comes a strong aspiration for community with teachers, mentors and peers. I want to be challenged by both like-minded and diverse individuals, I want to learn and be pushed to my intellectual limits from mentors and turn these interactions into a new network that with time and effort on both ends will transform into lifelong connections.

I show up with grit and tenacity to my endeavors, I owe it to my colleagues and I owe it to our ideas that we create as a team to do justice to our efforts. I value scientific integrity, community and innovation. Perseverance is infectious and I want to be a positive beacon in others pursuits. Progress is an artifact of empathy. I encourage my colleagues to be creative, think autonomously and have the right to question my every move. The path to innovation is not through memorization, but rather by creating an environment where others feel safe to take risks and make mistakes. I strive to continuously build communities where others around me feel safe to be fierce and the freedom to be unique.

My interest in MIT Solve is to learn from mentors in the healthcare space, to strategize a path to commercialization, to better understand regulatory hurdles, to be coached and challenged to my intellectual limits. Our team seeks to build upon our current pipeline and work with seasoned mentors and life science executives to support our business and scientific efforts in a cost effective and strategic manner. 

Through MIT Solve, the ultimate measures of success would be to further build connections within the MIT community and beyond, and work with advisors and peers. Success would be to expand upon R&D goals, to better understand the payers’ perspective, to uncover unknowns and strategize business and scientific goals. Another measure of success is to also learn from other founders, to better understand their journeys, their goals and how they combat challenges, and share lessons I have learned to support their growth as innovators and entrepreneurs.

Solve Advisor Dr. Noubar Afeyan co-founder and chairman of Moderna - I would love to be mentored by Dr. Afeyan to understand how he has built, grown and strategically positioned Moderna using innovative technology. To understand how he engages customers and stakeholders and what methods he has found effective for pushing the needle on transforming creative thinking and into actionable solutions.

Hadley D Sikes Lab at MIT is dedicated to advancing the field of genomics – I would to collaborate with her and/or the bioinformaticists in her lab to support development of AGED tools, selecting the most reliable candidate biomarkers and effective methods to improve assessing these markers in circulation.

Solve Staff – there are too many staff members to list here that I would love to get to know, but topics I would probe many of the solve staff with are decisions on innovation, policy, facilitating strategic partnerships, community engagement and so many other topics! I look forward to getting to know and meeting each of you.

Martin Trust Center for MIT Entrepreneurship – while the Martin Trust Center is dedicated to MIT students, it is essential at every stage in development that we work with innovative minds including fostering the development of students and interns. I would like to hire several interns here and allow them to gain first-hand experience of someone not too far from where they are.

AGED Diagnostic is developing the most accurate diagnostic tool for liver. Liver disease is the fasting growing epidemic and is associated with diabetes, obesity, metabolic syndrome and cardiovascular disease among several other risk factors. In the US, there are 100 million patients with liver disease of which 80 million have benign liver disease and 20 million have nonalcoholic steatohepatitis (NASH) which is progressive. 

The challenge for physicians is that there are zero noninvasive diagnostic tools that can differentiate benign from advanced liver disease. Liver related mortality has ethnicity disparities and socioeconomic disparities, and high barriers to entry are due to the invasive nature of liver biopsies which is the sole diagnostic tool for diagnosing NASH. AGED accurate and non-invasive diagnostic test will enable physicians to diagnose NASH at an early stage, reduce the financial burden on health insurers, increase early detection and intervention to reduce suffering and save lives.

AGED would like to be considered for the Robert Wood Johnson Foundation Prize and we will use these funds to close our pre-seed round to validate our core technology in the lab. Using advanced genomic tools and machine learning, AGED identified a list of candidate markers that can differentiate benign disease from NASH. We are testing the feasibility of these candidate biomarkers in patient blood using a targeted genomic sequencing assessment. This pilot study will enable our team to reach our impact goals for Q4 2021.

AGED Diagnostic is developing the most accurate diagnostic tool for liver. Liver disease is the fasting growing epidemic in the US and is associated with metabolic syndrome, cardiovascular disease and polycystic ovary syndrome. Pregnant women with liver disease are 4 times more likely to have adverse maternal-fetal outcomes, such as pre-term birth, preeclampsia, hypertension and bleeding.

Liver disease is the fasting growing epidemic affecting 100 million patients in the US of which 20 million have the advanced (progressive) form. The challenge for physicians is that there are zero noninvasive diagnostic tools that can differentiate benign from advanced liver disease. Liver biopsies are the sole diagnostic tool for diagnosing NASH and due to the invasive nature, many women are not diagnosed until complications arise. AGED accurate and non-invasive diagnostic test will enable physicians to diagnose NASH at an early stage, facilitate medical intervention, decrease complications for pregnant woman and save lives.

AGED would like to be considered for the Innovation for Women Prize and we will use these funds to close our pre-seed round to validate our core technology in the lab. Using advanced genomic tools and machine learning, AGED identified a list of candidate markers that can differentiate benign disease from NASH. We are testing the feasibility of these candidate biomarkers in patient blood using a targeted genomic sequencing assessment. This pilot study will enable our team to reach our impact goals for Q4 2021.

AGED Diagnostic is using genomic innovation and machine learning to develop the most accurate diagnostic tool for liver disease. Liver disease is the fasting growing epidemic affecting 100 million patients in the US of which 20 million have nonalcoholic steatohepatitis (NASH) which is progressive. The challenge for physicians is that there are zero noninvasive diagnostic tools that can differentiate benign from advanced liver disease. All serum tests on the market target genes/proteins found in other types of liver disease, as well as benign liver disease. AGED Diagnostic tool utilizes machine learning to select for the most highly reliable biomarkers. AGED accurate and non-invasive diagnostic test will enable physicians to diagnose NASH at an early-stage, reduce the financial burden on health insurers, and improve patient outcomes.

AGED would like to be considered for the The AI for Humanity Prize and we will use these funds to close our pre-seed round to validate our core technology in the lab. Using advanced genomic tools and random forest machine learning approach, AGED has identified a list of candidate markers that can differentiate benign disease from NASH. We are testing the feasibility of these candidate biomarkers in patient blood using a targeted genomic sequencing assessment and will utilize machine learning during all stages of development through FDA clearance. This current pilot study will enable our team to reach our impact goals for Q4 2021. Random forest and other machine learning approaches will enable AGED to develop the most accurate diagnostic tool for liver disease.