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Quanterix, Mobidiag, WuXi NextCODE, And More: News From December 2017

January 3, 2018 | December featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Quanterix, Mobidiag, WuXi NextCODE, and more.

Quanterix announced the commercial availability of its SR-X Ultra-Sensitive Biomarker Detection System. The Company’s latest instrument, powered by Simoa technology, opens the door for researchers to access ultra-sensitive protein and nucleic acid detection capabilities in a more compact and affordable system. Quanterix has a rapidly growing network of academic researchers and pharmaceutical and biotech customers using Simoa to see and measure critical biomarkers across a range of therapeutic areas, including oncology, neurology, cardiology, inflammatory, and infectious disease, that have previously gone undetected. Now shipping, the SR-X provides researchers with the additional flexibility to design assays to detect both proteins and nucleic acids direct from blood, and a host of other complex sample types, without the need for error-prone and complex preparation processes. The unique capabilities of the SR-X enable measurement of ultra-sensitive nucleic acid levels, including miRNA, without PCR, expanding the potential for Simoa’s applications. Press release

Mobidiag launched Novodiag, a fully automated solution for syndromic and targeted testing of infectious diseases, supporting limitation of antibiotic use. The end of 2017 has been marked by a key event for Mobidiag, the launch of the Novodiag solution at the Finnish Embassy in Paris (France) with the support of M. Ambroise Fayolle, VP of the EIB (European Investment Bank) and Dr. Etienne Ruppé, MCU-PH/Associate Professor, bacteriology department at Bichat hospital (Paris, France). The new Novodiag solution allows direct analysis of a patient sample placed in a disposable cartridge and delivers comprehensive results within a few hours. In a time where antibiotic resistance is a major threat for global health, the optimized process offered by Novodiag allows, among other things, to detect antibiotic resistance and limit the systematic use of antibiotics. This instrument allows detection of infectious diseases in a few hours and supports infection management accordingly. This molecular diagnostic solution offers an easy to use and cost-efficient method, with very limited hands-on-time and without the need for much technical expertise. Novodiag is particularly suitable for low volumes and on demand testing for clinical laboratories. Press release

2bPrecise has launched their pharmacogenomics (PGx) solution to bring critical data to the clinical workflow in real time. 2bPrecise PGx makes pharmacogenetic information accessible and actionable so physicians can make informed treatment decisions based on a patient’s unique genetic makeup. 2bPrecise has partnered with Translational Software (TSI) to leverage its knowledge-base of PGx content. The National Institutes of Health (NIH) reports that adverse drug events result in more than 770,000 injuries and deaths each year, underscoring the importance of PGx for individualizing therapy. The 2bPrecise PGx solution uniquely plugs into the EHR’s native workflow and can integrate content from TSI and other knowledge sources to enable decision making at the point of care. 2bPrecise’s PGx solution is part of its larger precision medicine platform, built to capture and store genomic data from a range of sources, enabling the harmonization clinical knowledge and genomic research to extract patient-specific insights. 2bPrecise’s unique approach to clinical workflow integration and dynamic content connectivity sets it apart from others in the pharmacogenomics space and helps future proof healthcare organization as genomic science advances. Press release

WuXi NextCODE announced the appointment of Christina Waters as senior vice president, focusing on our rare disease programs. Waters will apply her two decades of experience to grow the company’s rare disease platform by reaching out to and integrating patients and patient communities, leveraging our capabilities and those of our partners to benefit even more people around the world. WuXi NextCODE presently serves as the diagnostics engine for major research hospitals and national health systems and genome projects in the US, China, UK, Ireland, Singapore and Qatar, and has assembled the world’s leading knowledgebase of genome variation for diagnosing rare disease. Under Waters’ leadership the company aims to extend the breadth and impact of its platform by using existing networks and global social media to identify and connect rare disease patients wherever they are. WuXi NextCODE plans to employ the full range of its capabilities – from sequencing through interpretation, AI and large-scale discovery – to generate new datasets, communities and cohorts that will make it possible to diagnose more cases, understand the biology of rare disorders, and drive therapeutic development. Press release

Cancer Genetics announced it has received approval for Thermo Fisher Scientific’s Oncomine Dx Target Test from the New York State Department of Health. The first FDA-approved test of its kind, the Oncomine Dx Target Test is playing an increasingly important role in lung cancer diagnostics, a market that is projected to reach $3.65 billion by 2024. The Oncomine Dx Target Test is a next-generation sequencing (NGS)-based companion diagnostic (CDx) that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC), including the combined therapy of dabrafenib and trametinib, crizotinib, or gefitinib. CGI was one of the first laboratories in the country to make the novel 23-gene test available to the medical community. The Oncomine Dx Target Test helps physicians match patients to targeted therapies in days rather than weeks, eliminating the need for a time-consuming, sequential single-biomarker testing approach. Press release

Inflammatix announced that Oliver Liesenfeld has been appointed chief medical officer. Liesenfeld, a veteran of the diagnostics industry, comes to the company from Roche Molecular Diagnostics, where he served as chief medical officer since 2012. Liesenfeld will oversee the clinical studies and regulatory approvals needed to commercialize Inflammatix’s HostDx tests, which will initially target acute infections and sepsis, respectively. These tests use the company’s novel, validated, bioinformatics-based approach of reading the genomic “fingerprint” of the host response to disease to quickly determine if a patient has a bacterial and/or viral infection – and thus, whether they need antibiotics – and to measure the severity of disease to determine if the patient is likely to have or develop sepsis. Press release

Genetic Analysis (GA) and Bio-Rad Laboratories announced that they have signed a supply and distribution agreement for Genetic Analysis’s GA-map clinical test for gut dysbiosis. The patented GA-map technology is used as an aide in the diagnosis and management of irritable bowel syndrome and inflammatory bowel disease. Dysbiosis is a microbial imbalance or maladaptation on or inside the body and is most commonly reported as a condition in the digestive tract. It has been associated with illnesses, such as inflammatory bowel disease and other chronic diseases. Press release