Redefining Antibiotic Informatics
We can't ignore the statistics
150 million Urinary Tract Infections (UTIs) occur annually, making it one of the most common infections worldwide and costing $6 billion globally[1]. Antibiotic Resistance is on the rise and accelerating.
E. coli, the bacteria responsible for more than 80% of UTIs, has become a heightened health issue and doctors are running out of oral antibiotics that can treat UTIs, especially common in women[2].
Over-prescription of antibiotics is a leading cause of antibiotic resistance. In many cases, antibiotics are prescribed before the actual bacterium is identified and the Antibiotic Susceptibility Profile is known. As a result, half of these UTI prescriptions are not needed[3]. Over-prescription, in part, is due to slow and imprecise diagnostics used in the current UTI standard of care, representing a critical unmet need.
MICROBEDX. A DISRUPTIVE
SOLUTION IN UTI DIAGNOSTICS.
• Many times antibiotics are prescribed before the bacterium is identified;
50% of these prescriptions are unneeded[8].
• Current UTI Diagnostics take up to 72 hours to identify the bacterium
and then conclude Antibiotic SusceptibilityTesting.
• With MicrobeDx no antibiotic prescription is needed
before testing is completed.
• Bacterium Identification Testing requires only 30-45 minutes.
• Antibiotic Susceptibility Testing is concluded and
Personalized Antibiotic Therapy prescriptions are available
in under 3 hours.
SOCIAL MISSION
Over 150 million UTIs occur annually worldwide, making it one of the most common infections, primarily in women[9]. MicrobeDx is committed to improving patient care for those suffering from Urinary Tract Infections by delivering rapid and reliable diagnostic testing, thereby curbing the rise of antibiotic resistance and the increasing costs of community and hospital-acquired UTIs.
The Issue
Antibiotic resistance is the ability of microbes to resist the effects of drugs; germs are not killed and their growth is not stopped. With current practices, bacteria will learn to resist all antibiotics over time.
The Technology
MicrobeDx uses rapid molecular testing for bacterium identification in 30-45 minutes and Antibiotic Susceptibility Testing in 3 hours or less. The detection method is agnostic and the platform can be expanded for use in diagnostics on any body fluids.
The Benefits
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Reduces over-prescription of antibiotics with faster, accurate bacterium identification in 30-45 minutes.
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Enables targeted, personalized antibiotic therapy in up to 3 hours.
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Decreases hospitalizations and costs for complex patients with higher antimicrobial resistance profiles, including immediate Rx prescriptions and prescription changes.
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Promotes stewardardship for responsible and sustainable antibiotic therapy for reduced resistance over the long-term.
THE SCIENCE
The Advantages
The MicrobeDx platform represents a differentiated and disruptive innovation in diagnostics:
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No cell isolation is required as per the convention, thus avoiding the significantly slower process.
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This dynamic approach is appropriate for testing in most body fluids: urine, blood, cerebrospinal fluid and peritoneal fluid.
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The technology utilizes hybridization and capture of target Ribosomal RNA, thus leveraging its natural amplification and negating the need for polymerase chain reaction (PCR).
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The system is currently being automated.
The Analyte
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With MicrobeDx’s proprietary technology, the assay is rapid and highly efficient, targeting up to 100,000 molecules within the cell. Similarly, it is extremely sensitive, accurately assaying even small quantities of bacteria and providing species specific identification.
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Furthermore, the phenotypic approach to antibiotic susceptibility testing (AST) at the base of MicrobeDx’s platform provides analysis of the bacterial response to a multitude of antibiotics. This phenotypic path to AST avoids the pitfalls of a genotypic approach, which is a retrospective analysis and does not optimally address the constantly evolving new resistance genes of bacterial DNA going forward.
The MicrobeDx diagnostic platform is a rapid, revolutionary system, which has broad utility. This technology was developed by a team of seasoned UCLA scientists over a 13-year period in conjunction with NIH grants of $12 million and is protected by a robust patent estate.
Proprietary,
Species Specific
Identification and
Quantification
Species Specific Ribosomal RNA Sequence
MicrobeDx’s
Proprietary
Ribosomal RNA
Sequence
PERSPECTIVES
"Without urgent action we are heading for a post-antibiotic era, in which common infections… can once again kill[11].”
- WHO, Antimicrobial Resistance
Global Report on Surveillance 2014
"Every time antibiotics are used in any setting, bacteria evolve by developing resistance. This process can happen with alarming speed…These drugs are a precious, limited resource – the more we use antibiotics today, the less likely we are to have effective antibiotics tomorrow[13].”
- Steve Solomon, MD
Director of the CDC’s Office of Antimicrobial Resistance
"Rapid and accurate diagnosis of bacterial infections is critical both to promote optimal patient outcomes (lower adverse events, shorter hospital stays, and better long‐term prognoses) and reduce the selection of antibiotic‐resistant organisms. Yet, the results for most currently available diagnostics are not available in sufficient time to inform treatment decisions in outpatient settings, where most antibiotics are prescribed, as well as in many hospital settings where acute illness requires empiric antibiotic selection before relevant information is available[15].”
- President’s Council of Advisors on Science and Technology (PCAST) Antibiotic Resistance Working Group
"Think of a puzzle, you need lots of different pieces to get a result that is resistant to everything. This is the last piece of that puzzle, unfortunately, in the United States. We have that genetic element that would allow for bacteria that are resistant to every antibiotic[12]."
- Beth Bell, MD
Centers for Disease Control and Prevention
"Although resistant bacteria have been around a long time, the scenario today is different from even just 10 years ago. The number of bacteria resistant to many different antibiotics has increased, in many cases, tenfold or more. Even new drugs that have been approved are confronting resistance, fortunately in small amounts, but we have to be careful how they're used. If used for extended periods of time, they too risk becoming ineffective early on[14].”
- Stuart Levy, MD
President of the Alliance for the Prudent Use of Antibiotics
EXECUTIVE TEAM
Announcement Re Dr. David A Haake Resignation..
Dr. David A Haake has left the company to pursue other opportunities. The Board is grateful to Dr.Haake for his contributions to the development of the MicrobeDx technology for detection and assessment of urinary tract infections and their antibiotic sensitivities, his role in founding the company, and his service as Chief Scientific Officer and Board Member. We wish him well in his future ventures.
Bernard M Churchill M.D.
Chairman of the Board
Bernard M. Churchill, MD
Bernard Churchill, MD, serves as the Chief of Pediatric Urology at UCLA and brings over 40 years of clinical experience. His previous roles include Fellow at the American Academy of Pediatrics and the Royal College of Surgeons of Canada and has served as Chief of Pediatric Urology at Sick Children Toronto. Dr. Churchill specializes in Urinary incontinence, Urinary Tract Infections, and Bladder abnormalities and is a well-recognized expert with numerous academic papers in his study of Urology and Pediatric conditions.
Chairman of the Board & CEO
Michael Churchill
Michael Churchill is a Merchant Banker and investor with interests in private equity, aggregate, real estate, bio tech, and resource companies. Mr. Churchill has held senior management roles and served as a member of the board for both private and publicly traded companies ranging in enterprise value from $5M to $2B. Most recently, he served on the board and the audit committee of Kirkland Lake Gold Inc. a gold mining company with approximately 2000 employees and an enterprise value of approximately $2B.
Chief Financial Officer
Chuck Blevins, PhD
Chuck has 28 years of experience in medical devices and diagnostic as a new product development project leader with additional quality systems, regulatory compliance and system implementation expertise. Chuck has directed all facets of programs from concept to post-launch, and has organized, built and led high-performing, global cross-functional teams. He is recognized for leading and launching 23 medical device products and reducing new product development cycle time for Johnson and Johnson, Edwards Lifesciences as well as in the contact lens space.
Director of Product Development
Warren H. Otto
Mr. Otto has 37 years of investment experience, including in real estate asset and portfolio management and market research. From 1994 through September 2007, he worked as a Portfolio Manager at RREEF, serving as a Managing Director during the last five years of his tenure. His prior experience also includes 15 years with The Landsing Corporation, a real estate investment management and syndication firm headquartered in the San Francisco Bay Area, where he performed a variety of services including acquisition, disposition, asset management and market research. Mr. Otto holds a degree in economics from Harvard College.
Board Observer
Marc Madou, PhD
With 35+ years experience, Dr. Marc Madou holds Chancellor’s Professor positions in the Departments of Mechanical and Aerospace Engineering; Biomedical Engineering; and Chemical Engineering and Materials Science and runs the Madou Lab at UC Irvine. His UCI team pioneered CD-fluidics and C-MEMS to replace flourescence detection in molecular diagnostics and has ongoing international research collaborations on the implementation of CD-fluidics and C-IDEAS. He was VP of R&D at Nanogen and in 2001 he founded Teknekron Sensor Development Corporation (TSDC), a leader in electronic manufacturing. Marc has a B.Sc., M.Sc. and Ph.D. in Semiconductor Electrochemistry from Rijksuniversiteit in Belgium.
Advisory Board Member and Consultant