- Posted Monday March 18, 2019
Licensing agreement puts DeepChek®-TB one step closer to clinical application
FLAGSTAFF, Ariz., and LUXEMBOURG CITY, Luxembourg — March 18, 2019 — In an important step toward eradicating tuberculosis (TB), the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, has signed a licensing agreement with an international biomedical firm, Advanced Biological Laboratories (ABL), to market and distribute TGen’s patented Next Generation Sequencing based TB test technology.
For now, the test — called DeepChek®-TB — is available for research use only. ABL is working toward distribution of a compact, portable and affordable diagnostic model that physicians worldwide could use to help determine the most appropriate treatment for each TB patient.
Current tests can take 6-9 weeks to complete. The DeepChek®-TB test can be completed in just 2-3 days, and can identify drug-resistant TB among mixed infections.
Thanks to modern medicine, TB in the U.S. continues to be a relatively minor threat. Globally, however, nearly one-fourth of the world’s population is infected with this lung-damaging communicable disease, which is estimated to kill more than 4,300 people a day — nearly 3 people every minute — worldwide.
“Significantly, our TB assay technology holds the potential to provide doctors — even those in relatively rural settings — a quick and economical way to accurately determine the exact drugs that can and can’t be used for each patient,” said Dr. David Engelthaler, Co-Director of TGen's Pathogen and Microbiome Division.
TB remains a major public health threat throughout developing nations and is increasing in some places as mutant versions of this infectious lung disease become resistant to current drug treatments. Identifying rapidly mutating, drug-resistant strains of TB is the greatest challenge to eradicating this disease.
ABL, based in Luxembourg, is a leading integrated diagnostics and medical technology company. Its licensing agreement with TGen will enable ABL to distribute DeepChek®-TB through its worldwide network of clinicians and distributors in more than 80 countries.
“We look forward to making the DeepChek®-TB test available to our global network immediately, and expect a strong demand for this test from leading research facilities worldwide,” said Dr. Chalom Sayada, Founder and CEO of ABL.
As a component of the World Health Organization’s (WHO) UNITAID End TB Strategy, the DeepChek®-TB test could help reach the target of a 95 percent reduction in TB deaths and a 90 percent reduction in new cases by 2035.
In the U.S., there are more than 9,000 TB cases diagnosed annually, which is a more than 80 percent reduction from 50 years ago. However, today’s drug resistant TB places a huge economical toll on the healthcare system, costing more than $500,000 on average to treat each of the most drug-resistant patients.
"This is a precision medicine test, that is, it’s a test designed to give specific treatment information for each patient," Dr. Engelthaler said. "Drug-resistance occurs when the wrong antibiotics are prescribed at the wrong time. This new approach is designed to not only help doctors better treat patients, but also to help slow or stop the global threat of multi-drug resistant Mycobacterium tuberculosis.”
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About TGen, an affiliate of City of Hope
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and complex rare diseases in adults and children. Working with collaborators in the scientific and medical communities worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen
TGen Senior Science Writer
About Advanced Biological Laboratories (ABL SA)
Advanced Biological Laboratories (ABL), S.A., is a Diagnostic and Medical Software company founded in 2000 as a spin-off from CRP-Santé Luxembourg. ABL's products offer to infectious disease clinicians, virology and microbiology laboratories optimal and efficient solutions (assays and software systems related to HIV, Tuberculosis, HCV, HBV, HPV, CMV, HPV, Flu…) for sequencing (DeepChek®) clinical genotyping, viral load (UltraGene™) and drug resistance analysis, including powerful fully integrated databases and analysis systems that combine standard and high-throughput Next Generation Sequencing data. ABL took control of TherapyEdge, Inc. in 2004 and in 2013 the rights to all viral hepatitis B & C related assets from EVIVAR MEDICAL as well as a personalized medicine electronic medical record system (EMR) in infectious disease from GlaxoSmithKline in 2016. In July 2018, acquired CDL Pharma to develop CRO related services and assays manufacturing capacity. In March 2019, ABL signed a non-exclusive global licensing agreement to distribute miRpredX™, IntegraGen’s proprietary IVD CE marked diagnostic test that enables clinicians to identify metastatic colorectal cancer patients who have a higher likelihood of response to anti-EGFR therapy. ABL has a comprehensive suite of healthcare management products, including Nadis®, TherapyEdge®, ViroScore®, SeqHepB, DeepChek®, UltraGene®, VisibleChek®, HepatiC® and the DPM used for data and patient management, monitoring and personalized reporting applications. In 2012, some of ABL's products also received CE-marking for IVD use. ABL's products like ViroScore® Suite and DeepChek® are for research use only in the United States, and the data processing module is an FDA registered class I medical device. These are currently available for Research Use Only.