Talis Awarded NIH RADx Contract to Launch Talis One™ System for Point-of-Care COVID-19 Testing and Further Strengthens Financial Position and Leadership Team

Company awarded $25 million in NIH RADx contract and secures $100 million new financing 

Industry leaders appointed to executive team, Board of Directors and Scientific Advisory Board 

MENLO PARK, CALIF. – July 31, 2020 – Talis Biomedical Corporation, a company dedicated to developing high-performance point-of-care diagnostic tests for infectious diseases, today announced that it has secured a $25 million contract from the National Institutes of Health (NIH) for Phase 2 of its Rapid Acceleration of Diagnostics (RADx) initiative. Additionally, the company has completed an additional financing of $100 million. This new funding will be used to scale manufacturing for the launch of the Talis One™ diagnostic platform, which provides rapid and highly accurate detection of COVID-19 at the point-of-care. 

 The company also announced that industry veteran Roger Moody has joined the management team as Chief Financial Officer, Kim Popovits has joined the Board of Directors, and Walter Koch, Ph.D., has joined the Scientific Advisory Board. 

“This is an exciting milestone,” said Bruce Tromberg, Ph.D., Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech, one of four components of the NIH RADx initiative. “It will help increase U.S. testing capacity exponentially. Game-changing technologies emerging from our RADx pipeline will inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.” 

“We are extremely proud that the NIH selected Talis, out of a field of 600 applicants, to be among the first teams to move to the final phase of the RADx initiative. This important funding will accelerate the commercialization of our Talis One System for the detection of COVID-19. Additionally, we are pleased to have the continued support of our investors, who share our excitement about the significant impact the Talis One System can deliver as a fast and reliable diagnostic testing platform for life-threatening and life-altering infectious diseases,” said Brian Coe, Co-Founder and Chief Executive Officer of Talis. 

“In response to the significant need for rapid, highly accurate testing solutions to help combat the pandemic, we were able to utilize our Talis One System, which we have been developing for clinical use in women’s health, to quickly develop an assay for SARS-CoV-2, the novel coronavirus that causes COVID-19. We are particularly focused on serving vulnerable populations, such as those in elder care facilities or patients with impaired immune systems. With the support of the NIH RADx program and proceeds from the new financing, we are confident that we will be able to accelerate our goal of making rapid diagnostic testing widely available,” added Coe.

The Talis One COVID-19 assay project is supported by the RADx program and has been funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00010.

New Management Team, Board and SAB Members

Roger Moody, Talis’ new Chief Financial Officer, is an accomplished finance executive with a wealth of experience in finance operations. Before joining Talis, he was Chief Financial Officer at Clinical Genomics, a colorectal cancer diagnostics company. He also held Chief Executive and Chief Operating Officer roles at Glysure Limited, a UK-based company specializing in continuous glucose monitoring, and Chief Financial Officer and other executive positions at Nanosphere, Inc. and Medsn, Inc. He earned a B.S. in finance from Syracuse University and an M.B.A. with a focus in finance from the University of Chicago Booth School of Business.

Kim Popovits, a new member of Talis’ Board of Directors, is the former Chairman of the Board, President and Chief Executive Officer of Genomic Health. Under her leadership, Genomic Health became the world’s leading provider of genomic-based diagnostic tests that optimized the treatment of cancer, resulting in an acquisition by Exact Sciences in November 2019. Prior to joining Genomic Health, Ms. Popovits held several management roles at Genentech where she led the commercialization of 14 new therapies. In addition to Talis, she serves on the boards of 10X Genomics, Kiniksa Pharmaceuticals, Ltd. and MyoKardia, Inc. She earned a B.A. in business from Michigan State University.

“I was attracted to Talis because of the potential of the Talis One System to make a significant impact on the diagnosis and management of patients with serious infectious diseases, its world-class science and technology, and its experienced management team,” said Popovits. “By enabling fast, highly accurate and convenient molecular diagnostic results at the point-of-care, rather than days later from a central lab, Talis is well positioned to help people get the answers they need to make urgent, time-critical decisions during this pandemic and beyond.”

Dr. Walter Koch, a new member of Talis’ scientific advisory board, spent 22 years at Roche Molecular Systems, Inc., where he held a number of leadership positions of increasing responsibility. From 2005 to 2020, he served as Vice President and Head of Global Research, providing overall leadership and strategic direction for all research activities including technology development and evaluation, biomarker discovery and validation, infectious disease diagnostic assay early development, and oncology companion diagnostics. Prior to Roche, he spent 11 years at the U.S. Food and Drug Administration (FDA), where he held several positions, most recently Acting Lab Chief, Laboratory of Immunochemistry, in the Center for Biologics Evaluation and Research (CBER). He earned a B.S. in Chemistry from the University of Memphis and a Ph.D. in Pharmacology and Toxicology from the University of Tennessee Health Science Center. He completed a post-doctoral fellowship in Environmental Health Sciences at Johns Hopkins University.

About the Talis One System

The Talis One System is a compact, easy-to-use, highly accurate molecular diagnostic platform developed to enable rapid, point-of-care testing for infectious diseases. The Talis One assays are based on a proprietary, highly optimized nucleic acid isothermal amplification chemistry to achieve exceptional test performance much faster than traditional PCR. The system is designed for use in non-laboratory settings, such as physicians’ offices, urgent care clinics, elder care/assisted living facilities, cancer treatment and dialysis centers, and potentially the workplace. 

COVID-19 is the first infectious disease that the Talis One System will support. Future infectious disease indications may include assays for other respiratory infections, such as influenza, as well as sexually transmitted infections (STIs) and other infections impacting women’s health. The Talis One instrument can be managed remotely and sends test results to a cloud database for secure transmission, storage and review. Results are available in 30 minutes or less. 

About Talis 

Talis is dedicated to providing broad access to fast, highly accurate, actionable diagnostic testing to ensure better treatment and disease management for patients with infectious diseases. The company is developing the Talis One™ System, a compact, molecular diagnostic platform that is Cloud enabled, to provide rapid and reliable point-of-care testing for infectious diseases across a wide range of healthcare settings, from the doctor’s office to the hospital bedside to remote care settings. Talis is headquartered in Menlo Park, California. For more information, please visit talis.bio.

Talis Biomedical Corporation announces expansion of Scientific Advisory Board

Jane Schwebke, M.D., joins the Talis SAB

MENLO PARK, Calif., Oct. 11, 2018 /PRNewswire/ — Talis Biomedical Corporation is pleased to announce the expansion of their Scientific Advisory Board and the appointment of Dr. Jane Schwebke, MD, Professor of Medicine in the Infectious Disease Division at the University of Alabama at Birmingham and Consultant to the Jefferson County Department of Health STD clinic.

Talis is driven by the mission to transform medical care by enabling rapid molecular testing in the near patient setting.

Dr. Schwebke will work closely with the Talis team and with Dr. Rustem Ismagilov, chair of the SAB, to advance the mission in the areas of sexually transmitted infections and Women’s Health.

Brian Coe, Talis’ Chief Executive Officer, stated: “We are honored to announce the expansion of our Scientific Advisory Board. It is a testament of the scientific and clinical enthusiasm for our pioneering solution, and we are privileged to welcome Dr. Jane Schwebke to our SAB.”

Dr. Schwebke stated, “I am very excited to serve on the Talis SAB. There is a critical need for rapid STD and women’s health diagnostic testing and I believe Talis will provide the solution.”

About Dr. Schwebke:

Dr. Schwebke received her medical degree from Northwestern University Feinberg School of Medicine and has been in practice for more than 20 years. She began her career in the field of STDs in 1987 during her fellowship in Infectious Disease at the University of Washington in Seattle. After her fellowship she became the medical director of the Harborview STD Clinic in Seattle where she remained until April 1991. She subsequently had a joint appointment at Northwestern University in Chicago and the Chicago Department of Health where she became the Director for the City of Chicago’s STD/HIV Program. Important contributions to the Program included merging STD and HIV, initiating HIV clinical care in the city’s clinics, initiation of cervical cancer screening in the STD clinics, creation of a clinical and behavioral research program, development of an adolescent clinic combining STD, HIV, and contraception services for Hispanic youth and addition of TB skin testing for STD clinic patients. She has been a faculty member at the University of Alabama at Birmingham for the past 24 years. Her major areas of research include the pathogenesis of bacterial vaginosis and its relationship to the acquisition of STDs as well as epidemiology and control of trichomoniasis.

Talis Biomedical Corporation awarded $5.6M by NIH

Talis Bio is developing a high-performance molecular point-of-care (POC) diagnostic platform to enable physician offices and clinics to run reference lab-quality diagnostic laboratory tests for infectious diseases. The $4.4M award from CARB-X, with the possibility of an additional $4.2M in milestone-based awards, will fund development of a rapid CLIA-waived molecular diagnostic test to detect chlamydia and gonorrhea directly from a patient sample in 20 minutes or less and development of a similarly rapid phenotypic antibiotic susceptibility test for gonorrhea.

Chlamydia trachomatis and Neisseria gonorrhoeae infections are on the rise; strains of multidrug-resistant N. gonorrhoeae, often called ‘superbug gonorrhoeae’, have been detected in a number of countries. The World Health Organization (WHO) estimates that each year, 131 million people are infected with chlamydia, and 78 million with gonorrhoeae. In the United States alone, approximately 820,000 new infections occur, according to the Centers for Disease Control and Prevention (CDC). When left untreated, these infections can result in serious complications and health problems for women (pelvic inflammatory disease, ectopic pregnancy, and miscarriage). Untreated gonorrhea and chlamydia can cause infertility in both men and women.

The Talis system leverages proprietary isothermal amplification chemistries, innovative engineering and powerful data science tools to enable users to load sample, walk away, and review results remotely. The high-resolution, digital quantification capability of the company’s proprietary SlipChip technology will enable the determination of susceptibility to antibiotics by measuring small molecular response differences between susceptible and resistant bacteria. The development of this phenotypic susceptibility approach, pioneered by students and postdoctoral researchers in the laboratory of Talis co-founder Rustem Ismagilov at Caltech, will be significantly advanced through continued collaboration. Results from the initial collaboration were published in a recent Science Translational Medicine paper.

“The support of CARB-X offers Talis an extraordinary opportunity to bring rapid pathogen identification and phenotypic anti-microbial susceptibility testing to the point-of-care,” said Brian Coe, Chief Executive Officer of Talis. “Beyond our initial menu items of chlamydia and gonorrhea testing, our intent is to build on this research to deliver a broad menu of testing capability to care providers around the world.”

“Talis Biomedical’s project could potentially speed up and improve the way drug-resistant gonorrhea and other serious diseases are diagnosed and treated. These diseases are a major public health problem worldwide, affecting millions of people’s quality of life and causing serious illness,” said Kevin Outterson, Executive Director of CARB-X. “The world urgently needs new diagnostics, antibiotics and other products to protect us from drug-resistant bacteria. N. gonorrhoeae is third on the CDC’s list of urgent antibiotic-resistance threats.