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CARB-X is funding Baebies Inc. to develop a rapid diagnostic for neonatal sepsis

CARB-X is funding Baebies Inc. to develop a rapid diagnostic for neonatal sepsis

Baebies’ new diagnostic would detect a bacterial infection, identify the pathogen and enable clinicians to determine which antibiotics would be most effective

(BOSTON) – CARB-X is awarding Baebies Inc., based in Durham, North Carolina, USA, up to $3.9 million to develop a rapid easy-to-use diagnostic for neonatal sepsis, a severe condition related to bacterial infections which, according to studies, kills an estimated 1.4 million young children world-wide each year.  Baebies will be eligible for up to $7.7 million in additional funding from CARB-X if project milestones are met, subject to available funds.

Baebies is a developing a diagnostic platform that will first determine, from a small blood sample, if there is a bacterial infection, and if so, which pathogen is causing the infection, enabling physicians to determine which antibiotics would be effective in treating the infection. This diagnostic will also measure host response markers unique to neonatal populations.

“Each hour delay in diagnosing infections and treating sepsis increases the risk of death and damage,” said Erin Duffy, R&D Chief of CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative antibiotics, vaccines, diagnostics and other life-saving products to address antibiotic-resistant bacterial infections. “Rapid diagnostics are essential tools in the race against antibiotic-resistant bacteria. They help curb inappropriate use of antibiotics and help speed effective treatment, which can save lives and reduce the spread of drug-resistant bacteria.”

“There is a critical need for a rapid and easy-to-use diagnostic platform for bacteremia – especially for the newborn population given the low circulating blood volume available for testing. Through this CARB-X partnership, the development of blood culture and identification of bacteria on our FINDER platform not only enables clinicians to receive results fast, but also conserves the limited blood volume by maximizing the diagnostic yield. Minimizing sample volume is crucial when it comes to testing infants,” said Vamsee Pamula, co-founder and President of Baebies. “The extra ‘e’ in Baebies demonstrates our commitment to ensure a healthy start for every child and sepsis is a fatal condition affecting neonates and children everywhere. We are looking forward to applying our technology towards a solution for neonatal and pediatric sepsis.”

Sepsis is the body’s overwhelming and life-threatening response to infection caused by bacteria, including drug-resistant bacteria, which can lead to tissue damage, organ failure, and death. Sepsis kills 270,000 Americans each year.  The toll is much higher in low- and middle-income regions where sanitation and health care are limited, particularly among children and newborns.

The Baebies diagnostic platform uses digital microfluidics technology and would produce results from a small blood sample, in line with blood-sample volumes available from infants. It would detect the presence of bacterial pathogens direct from whole blood within 15 minutes, followed by a post-blood culture rapid 15-minute molecular test for pathogen identification and antibiotic sensitivity to identify which antibiotics could effectively treat the infection. In addition to blood culture, the platform will also be able to measure expression levels of various genes from just 125 microliters of whole blood to distinguish between different causes of inflammatory responses. The project is in the Feasibility phase of development.

Supporting global antibacterial innovation to address drug resistance

The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 56 active projects focused exclusively on drug-resistant bacteria, including nine rapid diagnostics. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. The goal is to support projects through the early phases of development so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.

Since its launch in 2016, CARB-X has announced 85 awards worth more than $322 million, with the potential of additional funds if project milestones are met. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.

CARB-X funds only projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High. The WHO estimates that 700,000 people die each year from antibiotic-resistant infections, including 35,000 in the US and 33,000 in Europe.

CARB-X funding for this project is provided by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). The contents of this release are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders. 

Contacts:

CARB-X
Jennifer Robinson
carbxpr@bu.edu

Baebies
Emily McLoughlin
emcloughlin @ baebies.com

About CARB-X
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).  CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/.  Follow us on Twitter @CARB_X.

About Baebies
Baebies, guided by the vision that “everyone deserves a healthy start”, develops and commercializes products and services that enable early disease detection and comprehensive diagnosis. Baebies has shipped over 10 million tests. Baebies’ SEEKER® is an FDA-authorized and CE-marked high throughput newborn screening platform. Recently launched, Baebies’ FINDER SARS-CoV-2 Test and the FINDER 1.5 Instrument are now available for sale in the U.S. – both of which have been validated but FDA’s independent review of this validation is pending. FINDER®, a CE-marked flexible, single sample testing platform, is under FDA 510(k) review and is currently not commercially available in the U.S. Our mission is to save lives and make lives better for all by bringing new technologies, new tests and new hope to children, parents and healthcare professionals worldwide. To further our mission, Baebies also provides expanded newborn screening services from our CLIA-certified laboratory. Baebies is headquartered in Durham, North Carolina. For more information, visit baebies.com and follow us on LinkedIn, Twitter and YouTube. 

About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.

About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK). 

About BMBF
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields. 

About Boston University 
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at jeremy22@bu.edu. www.bu.edu.