May 30, 2019 | May featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Two Pore Guys, TTP, Caris, and more.
Two Pore Guys, best known for its silicon pore detection platform, has rebranded as Ontera to reflect its broader mission of providing better biological information for a healthier planet. As part of these changes, the company has appointed two seasoned executives to its management team: Murielle Thinard-McLane as Chief Executive Officer and Andrea Chow as Senior Vice President of Engineering. The company also announced that its lead investor, Khosla Ventures, has exercised its final warrant. Ontera’s primary focus is on supporting sustainable agriculture, a $5 trillion market faced with enormous challenges in light of climate change, population growth and lack of arable land. As the global community faces the need to feed more people, it is critical to bring about new innovation in crop management technologies that can increase yields and catch devastating diseases early. Ontera’s unique nanopore-based, single-molecule detection platform can help quickly identify and quantify crop traits, pathogens and pathogen resistance in the field in less than 20 minutes, enabling precision treatment of crops and thereby reducing the use of inefficient chemical spraying. This new, proactive approach to pest treatment will enable farms to save money and also work in a more sustainable way while preserving the potency of new crops and crop protection for longer. Thinard-McLane is a seasoned operations executive with decades of experience scaling organizations. Dr. Chow is a microfluidics product development executive with more than 15 years of experience advancing life science platforms and health diagnostics. Press release
TTP has announced that it has partnered with Quotient to develop and implement a state-of-the-art manufacturing facility for Quotient's proprietary MosaiQ system. MosaiQ, Quotient's proprietary multiplex microarray technology, offers the world's first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. The instrument is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Earlier this month Quotient announced receipt of the CE Mark for its initial Immunohematology (IH) Microarray for use with its MosaiQ diagnostic platform. Phil Rawlins, Program Manager at TTP, said in a press release, "This has been an incredibly exciting partnership as Quotient's MosaiQ platform is set to radically change the field of blood transfusion typing and screening. The unique printing capability of SureDrop is a perfect fit with this application and working with Quotient to commercialize a high-volume manufacturing system has been extremely rewarding." Press release
QIAGEN announced the US launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the US Food and Drug Administration, along with the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. QIAstat-Dx (formerly Stat-Dx DiagCORE ) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE technology, received CE-IVD marking in January 2018 and already has a significant installed base. QIAstat-Dx is being launched in the US with a comprehensive respiratory panel that detects more than 20 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx in the US, with plans to launch a gastrointestinal panel later in 2019. With the ability to multiplex as high as 48 targets, a deep pipeline is planned that will span infectious diseases, oncology, companion diagnostics and other disease areas. Press release
GladiaTOX, a new open-source solution for the analysis of high content screening (HCS) data in biomedical research, has been released on the online Bioconductor platform. Written in the R programming language, GladiaTOX enables robust and efficient storage, processing, and reporting of HCS data, in line with the landmark 21st Century Toxicology program. An evolution of the ToxCast PipeLine (TCPL), which was created for the US Environmental Protection Agency, GladiaTOX has been developed by Philip Morris International (PMI) in collaboration with Filer Consulting (Durham, North Carolina, USA), lead author of the original TCPL. "GladiaTOX is an all-in-one solution for the analysis of HCS data," said Vincenzo Belcastro, Systems Biology, PMI, in a press release. "It enables the standardization of HCS data and dependable, reproducible analysis procedures that facilitate rapid-decision making processes. For example, in the field of drug discovery and toxicity screening, where thousands of data points can be generated every day, GladiaTOX allows researchers to quickly and confidently identify and prioritize candidate chemicals. It achieves this through its unique modeling algorithms, its advanced reporting tools, and its ability to integrate easily with external proprietary systems." In line with 21st Century Toxicology, GladiaTOX supports the internationally recognized "3Rs" of animal research – "replacement, reduction, and refinement" – by improving the reproducibility of in vitro HCS studies. In addition, since GladiaTOX is able to analyze disparate types of HCS data in an integrated fashion, it supports the "3S" approach to biological understanding – "systematic, systemic, and systems" – which has been proposed by a team of researchers from institutions including the US Food and Drug Administration, the Center for Alternatives to Animal Testing, and the European Commission Joint Research Centre. The 3S approach recommends looking at organisms in their entirety, rather than at specific organs in isolation, through the integration of experimental and computational in vitro systems. Press release
Caris announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company's MI Transcriptome companion diagnostic (CDx) test. Designed to detect gene fusions in solid tumors, the test is intended to assist clinicians in identifying patients who may benefit from treatment with specific targeted therapies. Caris plans to submit the assay for Pre-Market Approval in late 2019. "The FDA Breakthrough Device designation for the MI Transcriptome CDx assay is a significant step in advancing precision cancer care for individuals with specific genetic profiles who could benefit from targeted treatment options," said W. Michael Korn, Chief Medical Officer of Caris, in a press release. "This also is an incredible milestone for Caris and the company's efforts to advance molecular science and cancer care by employing cutting edge technology for the detection of highly actionable molecular alterations." MI Transcriptome CDx is a next-generation sequencing-based in vitro diagnostic test that uses RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue to detect all classes of structural rearrangements, including fusions, deletions, inversions, and duplications, as well as measuring expression and splice variants in patients diagnosed with cancer. It has received Breakthrough Device designation for detection of novel FGFR biomarkers including gene fusions in solid tumors. Press release
Renalytix AI announced a collaboration with University Medical Center Groningen (UMCG), Netherlands, to evaluate KidneyIntelX across over 3,500 patients with Type II Diabetes. The study will assess how effectively KidneyIntelX identifies patients with fast-progressing kidney disease who would be most likely to benefit from new drug therapies to prevent or slow down their progression to end-stage renal disease and dialysis. As part of the planned evaluation, the KidneyIntelX test will be performed at multiple time points on over 9,000 patient samples from completed clinical trial biobanks, providing valuable insight into the potential utility of KidneyIntelX as a predictor of response to breakthrough therapies for the treatment of diabetic kidney disease. Hiddo J.L. Heerspink, Department of Clinical Pharmacy and Pharmacology, UMCG and lead investigator in the planned evaluation said in an official statement, "The ability of KidneyIntelX to discriminate fast-progressing kidney disease offers pharma the potential to enrich clinical trials with patients most likely to benefit most from novel drug therapies. Additionally, the potential to predict drug response in these patients is critically important to directing clinical use of new therapies." KidneyIntelX is designed to diagnose and improve clinical management of patients with Type II diabetes and those of African ancestry with fast-progressing kidney disease, in an effort to curtail the high global costs of Chronic Kidney Disease and end-stage renal disease. In the United States healthcare system alone, these costs are estimated at $114 billion per annum. RenalytixAI expects to commercially launch KidneyIntelX as a laboratory developed test in its CLIA laboratory facilities in the United States in H2 2019. Press release