TGen and ABL plan global rollout of advanced test for TB, one of the most deadly pathogens

FLAGSTAFF, Ariz., and LUXEMBOURG CITY, Luxembourg — Aug. 31 — Advanced Biological Laboratories (ABL) is expected to soon begin manufacturing of a compact, portable and affordable test for tuberculosis (TB), designed by the Translational Genomics Research Institute (TGen), an affiliate of City of Hope.

Under an expanded licensing agreement with TGen announced today, ABL will make, market and distribute this state-of-the-art TB test, which now covers the known important genes and mutations that cause resistance to current anti-TB drugs. This will help physicians determine the most appropriate treatment for each patient of TB, the world’s leading cause of death from a single infectious agent.

For now, this patented Next Generation Sequencing based TB test — called DeepChek®-TB — is available for research use only. The test is based on years of development at TGen, involving numerous research partners from across the globe.

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 nearly 1.3 million people annually, according to the U.S. Center for Disease Control and Prevention (CDC).

“The continued partnership between TGen and ABL is allowing for next generation science to be applied to patients suffering from the most important infectious disease of our time,” said Dr. David Engelthaler, Co-Director of TGen’s Pathogen and Microbiome Division. “The combination of TGen’s scientific advancements and ABL’s manufacturing and distribution channels means that someday soon people most at risk, in every corner of the globe, will be able to access the most advanced TB medical information.”

TB remains a major public health threat throughout developing nations and is increasing in some places as mutant versions of this disease become resistant to current drug treatments. Identifying rapidly mutating, drug-resistant strains of TB is one of the greatest challenges 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 are extremely pleased to upgrade our DeepChek®-TB test and cover additional resistance-associated mutations, and offer to microbiologists the capacity to perform comprehensive drug susceptibility testing on an exhaustive list of drugs, such as Capreomycin, Streptomycin, Quinolones, Pyrazinamide, Ethambutol, Kanamycin and Linezolid. Considering the extremely simple workflow of the solution, which does not require any library preparation, we expect a strong demand for this test from leading research facilities worldwide,” said Dimitri Gonzalez, Head of Diagnostics at ABL.

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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: http://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: http://www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen.

Steve Yozwiak

TGen Senior Science Writer

602-343-8704

[email protected]

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, 16s RNA…) 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®, BacterioChek, MicrobioChek 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.

Dimitri Gonzalez

Advanced Biological Laboratories

[email protected]

+352 263896761