Radio Interview with Ricardo Mancebo

Radio interview with GenEndeavor Founder & CEO Ricardo Mancebo at the BIO CEO & Investor Conference in New York City that aired on March 11, 2024. Courtesy of "Community Matters" Host, Jonjy Ananth and Co-host, Uma Ananth

GenEndeavor attending the New England Venture Summit Dec. 12 & 13, 2023

We look forward to being a part of the New England Venture Summit this week.

At GenEndeavor, our mission is clear: to prevent genetic and infectious diseases through early detection of pathological biomarkers. We're excited to share more details about our platform designed for the early detection of ovarian cancer, especially for high-risk asymptomatic women. If you're attending the summit, we’d welcome a conversation about @GenEndeavor’s investment opportunities. Please reach out if you’re interested. amanda@genedeavor.com. 

We’re hiring!

https://youngstartup.com/events/nevs23

GenEndeavor is pleased to welcome Atmika Paudel to our team!

‘With my expertise and experience in the field of infectious diseases, I aim to serve society for better health. I worked on the discovery of novel therapeutically effective antimicrobial agents and elucidated their action mechanisms. I further exploited invertebrate silkworms “Bombyx mori” to identify novel infectious agents and understand the pathogenesis of known pathogens. With a passion for science, I am excited to join GenEndeavor to expand the disease diagnostic horizon.'

-Dr. Atmika Paudel

Welcome Suresh Panthee to the GenEndeavor Team

‘I aim to leverage my expertise in the treatment of infectious diseases.

My early research in graduate school utilized chemical and genetic approaches to elicit the production of antibiotics and related compounds from Actinomycetes. Later, I exploited host-pathogen interaction to develop novel therapeutic strategies, including antibiotics and antivirulence drugs against Staphylococcus aureus. I am thrilled to join GenEndeavor and contribute to the development of the next generation of diagnostics and serve humanity.’

-Dr. Suresh Panthee

Making very early ovarian cancer screening possible

An estimated 1 out of 78 women will get ovarian cancer in their lifetime in the U.S. Over 65% of women are diagnosed with ovarian cancer after the disease has spread and when the 5-year relative survival rate is only ~25%-29%. If there were a test sensitive and specific enough to detect the early stages of ovarian cancer when the disease is still localized in women, then the 5-year relative survival rate could increase to over 90%. Currently, no screening test exists today to detect ovarian cancer early. This post is intended to elevate awareness and conversation around bridging the gap to enable early ovarian cancer detection and to make very early ovarian cancer screening possible.

GenEndeavor’s mission is to shift the paradigm of genetic testing by developing a new generation of technologies to enable early detection and screening of molecular biomarkers. We encourage updates on the latest research efforts and technologies to identify and detect ovarian cancer biomarkers for screening. We also encourage bringing ovarian cancer awareness to high-risk women, their families, and average-risk women in the general population to inform them about the current state of genetic testing and other preventative measures that can be taken. We welcome your feedback.

FDA Grants Breakthrough Device Designation for GenEndeavor’s Rapid Multi-Pathogen Test Panel for Bloodstream Infections

Breakthrough Device Designation provides expedited regulatory review for the RIM-Path ID Panel, a rapid bloodstream pathogen identification for patients with suspected blood stream infections, built on the company’s patented Isothermal Chain Reaction (ICR) technology platform

GenEndeavor LLC, a next-generation diagnostic assay development company focused on lowering the detection limit of pathogens and rare mutations, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Rapid Isothermal-Chain-Reaction Multiplex Pathogen Identification in Whole Blood Test, or RIM-Path ID panel. The test is designed to simultaneous detect and identify nucleic acid sequences from multiple known pathogen species directly from unpurified, uncultured human whole blood samples. The RIM-Path ID panel will test for more than 90% of bloodstream-infection pathogens and the most common resistance mutations in under 60 minutes using a patented, non-enzymatic, Isothermal Chain Reaction (ICR) technique that is instrument-agnostic.

Bloodstream infections (BSIs) are associated with significant risks of morbidity and mortality and significantly increased hospital lengths of stay. Current BSI diagnostic tests require up to several days to identify the causative pathogen species, delaying optimal antimicrobial therapy. In attempts to compensate for false-negative or inconclusive results and long diagnostic turnaround times in patients with suspected BSI, therapy is typically initiated using broad-spectrum antimicrobials before the causative infectious agents are identified.  This approach increases the risk of antimicrobial drug resistance and delays targeted treatments. Studies have shown that up to 40% of patients with bloodstream infections received ineffective therapy when broad-spectrum antibiotics were administered.

Timely identification of BSIs is also important in the diagnosis and treatment of hospitalized patients at risk of developing sepsis due to a possible BSI. Sepsis is a life-threatening illness that results from an infection that triggers a whole-body systematic inflammatory response. In the United States, more than 1.7 million people are struck by sepsis each year, accounting for 10% of all hospitalized patients and up to 52% of all hospital deaths. The high incidence of sepsis mortality is directly associated with a limited window of time in which to initiate effective antimicrobial therapy targeted against the causative pathogens. It is estimated that for every hour delay in administering appropriate antibiotics from the time a septic patient arrives in the Emergency Department (ED) to the initiation of targeted antibiotic treatment, there is an associated 10% increase in the 1-year mortality risk.

The availability of a rapid test that simultaneously identifies a large number of bloodstream infection pathogens from an unprocessed whole blood sample in under an hour with high sensitivity and specificity could transform the clinical management of patients with suspected BSI by significantly reducing the time to targeted treatment. Instead of a languishing for days on broad-spectrum antibiotics until a positive blood culture is achieved, treatment can start almost immediately with target-specific antimicrobials.

The RIM-Path ID panel will provide a more effective test for identification of pathogens in the bloodstream to aid in more rapid and effective diagnosis and treatment of patients with suspected BSI. RIM-Path ID will be the first non-enzymatic nucleic acid testing (NAT) assay technology, which means the absence of expensive enzymatic reagents, sample processing to remove enzyme inhibitors, and temperature cycling.

“Our goal is to address a critical and unmet global health need through the development of a new rapid test that can identify pathogen species in bloodstream infections directly from blood draws in under an hour with high sensitivity and specificity. The RIM-Path ID is intended to augment current bloodstream infection testing protocols with the aim to significantly decrease sepsis mortality, morbidity, and length of hospital stay.”

Ricardo Mancebo, Ph.D., Founder and CEO of GenEndeavor

According to the FDA, the goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to novel medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for regulatory clearance consistent with the Agency’s mission to protect and promote public health.

2022 World TB Day

Worldwide, 1.7 billion people representing ~23% of the global population, were infected with the Mycobacterium tuberculosis (TB) bacterium in 2018. As the leading cause of mortality among infectious diseases, TB accounted for 1.5 million deaths in 2020, with 230,000 of these deaths occurring in children. The same year, 10 million people became ill with the disease worldwide, including 1.1 million children, yet 30% of all these affected people did not receive the necessary healthcare to effectively treat their conditions, allowing further transmission of TB in the population. The World Health Organization (WHO) “End TB Strategy” is aimed at ending the global TB epidemic by 2030, with the goal to reduce deaths by 95% and new cases by 90% between 2015 and 2035.

Childhood TB disease is rarely detected or treated: The mortality rate of TB disease in children is significantly higher (23% in 2018) than in adults (14% in 2018) due to a TB diagnosis-treatment gap. Current TB tests require sputum, which is difficult to obtain from productive coughs in infants and young children. Furthermore, the relatively small number of bacteria (paucibacillary disease) typically found in infected children is below the detection limit of existing TB testing technologies. Therefore, current TB tests are unlikely to show a positive result in children. Studies based on modeling pediatric TB cases worldwide indicate that over 90% of children with TB disease never receive treatment and up to 95% of childhood TB deaths are not diagnosed or treated before the child dies. Greater than 95% of TB deaths occur in low- and middle-income regions, making rapid and cost-effective point-of-care TB testing a critical need for effectively preventing and treating TB disease in children. Early detection and diagnosis of TB in children combined with early therapeutic interventions could cure the vast majority of affected children.

Unmet Need: Currently, a rapid, sensitive, and cost-effective point-of-care screening test for TB in children does not exist. The WHO End TB Strategy is to treat at least 70 million people with latent TB and TB disease over a 5-year period by 2022, which would likely reach over 10 million children. To do this requires rapid point-of-care diagnostics that are more sensitive and accurate than existing tests, and that can be performed in non-sputum samples such as saliva and urine in minutes at a low cost. To address this critical and unmet global health need, GenEndeavor is working on new molecular technologies to develop a rapid low-cost sensitive community-based point-of-care TB test that can identify Mycobacterium tuberculosis in children directly from unprocessed saliva and urine in under 10 minutes without any lab equipment, enzymes, or electricity to enable early TB testing and diagnosis in children globally in decentralized settings.

GenEndeavor receives 2021 NIH Director’s Transformative Research Award

Hayward, CA, Oct. 5, 2021 -- GenEndeavor, with the mission to develop novel technology platforms to enable the rapid and early detection of genetic and infectious diseases, receives the 2021 NIH Director’s Transformative Research Award focused on COVID-19 research. GenEndeavor will use this 5-year grant award to develop a handheld air monitoring system to rapidly detect and quantify SARS-CoV-2 in real-time at the point of presentation.

The ability to rapidly monitor SARS-CoV-2 in aerosol at the point of presentation is critical to managing the risk of infection by airborne transmission as people return to their workplaces, communities, large events, and schools during the COVID-19 pandemic. However, current testing paradigms for detecting SARS-CoV-2 in aerosols are not amenable to rapid point-of-presentation air monitoring and SARS-CoV-2 quantification in real-time, leading to a poor understanding of SARS-CoV-2 transmission. “Our goal is to develop a tool to track, quantify, and prevent the spread of COVID-19, and to enable a basic understanding of SARS-CoV-2 aerosol transmission, such as viral exposure vs. risk, viral decay rate vs. infectivity, and viral load vs. infectious dose in SARS-CoV-2 airborne transmission,” said Dr. Ricardo Mancebo, Founder and CEO of GenEndeavor.

The NIH Director’s Transformative Research Award is part of the Common Fund’s High-Risk, High-Reward Research Program, which was created to accelerate the pace of scientific discoveries by supporting exceptionally creative scientists with innovative ideas with grant awards. The Transformative Research Award, one of the four NIH Director’s award programs, was established in 2009 to support scientists who are pursuing inherently risky innovative research projects that are transformative and have the potential to establish new paradigms and make a broad impact in biomedical, behavioral, or social sciences within the NIH mission.

“The science put forward by this cohort is exceptionally novel and creative and is sure to push at the boundaries of what is known,” said NIH Director Francis S. Collins, M.D., Ph.D. “These visionary investigators come from a wide breadth of career stages and show that groundbreaking science can happen at any career level given the right opportunity.”

“We are grateful to be one of the 19 recipients of the prestigious Transformative Research Award and for the opportunity to make an impact on the spread of COVID-19 by pursuing our out-of-the-box research project proposal and developing our new technology platform to transform how we air-monitor and thus control airborne-transmitted infectious diseases,” said Dr. Mancebo.

Grant Title: Development of a handheld rapid air sensing system to monitor and quantify SARS-CoV-2 in aerosols in real-time (Grant # 1 R01 DE031927-01)

Contact: media@genendeavor.com