May 23, 2018 | May featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including numares, BBI Solutions, Nanobiotix, and more.
numares announced the initiation of PARASOL, a European multicenter study, to continue building upon the clinical case from the results of the UMBRELLA study. AXINON renalTX-SCORE is a non-invasive, urine-based CE-marked in-vitro diagnostic test (IVD) for the diagnosis of kidney transplant rejection. It was launched in Europe in 2017 and is the first test available worldwide to evaluate a metabolic constellation rather than single biomarkers for the diagnosis of an acute rejection after transplantation. The randomized, multi-center study will enroll approximately 600 patients at five sites located in Regensburg, Germany, Vienna, Austria, Prague, Czech Republic, Grenoble, France and Barcelona, Spain. It will evaluate the use of the four-biomarker metabolic constellation for the detection of acute kidney allograft rejection of urine samples from patients at least 14 days after transplantation who are scheduled for renal allograft biopsy. numares’ approach utilizes the effects of a disease on the dynamics of human metabolism. These effects can be recognized as specific changes in metabolites caused by readjustments of the metabolic machinery due to the disease. The AXINON renalTX-SCORE test evaluates the status of a metabolite constellation, rather than quantifying just one or a few biomarkers as with more traditional diagnostics. The metabolic constellation is deciphered by employing machine learning tools to evaluate a large number of metabolites for inclusion in the constellation consisting of a small number of metabolites. Press Release
With the USA in recovery from one of the worst flu seasons on record, scientists at BBI Solutions have highlighted the role that new technology can play in re-optimizing the current generation of flu tests and ensuring communities are protected in peak flu season. Accurate diagnosis is key in identifying and rapidly treating influenza, and, in many cases, existing tests weren’t able to detect the virus, leaving communities at severe risk and contributing to the wider problem. To combat this, the FDA has issued new guidelines to improve the overall quality of testing for influenza and has reclassified rapid antigen influenza tests from Class I to Class II. The agency's new standard for rapid antigen tests is that they can give false negatives in no more than 20% of tests; previously there weren't established performance criteria for the tests. This has significant implications for manufacturers of influenza tests – who now need to take urgent steps to ensure their tests are re-optimized to identify the presence of influenza in potential sufferers. For manufacturers, this can be a particular challenge with existing test products that don’t meet the FDA’s criteria. BBI Solutions is utilizing its novel patent-pending Morffi signal enhancement technology, to work with manufacturers to boost the sensitivity of their rapid lateral flow influenza tests to help ensure that suspected flu sufferers can be rapidly and accurately identified. The new technology, which launched in 2017, boosts test sensitivity and provides an up to ten-fold improvement in the limit of detection, it can also offer a faster time-to-result for situations where a quick diagnosis is critical to patient care. Lateral flow tests can therefore be a vital weapon in the in the battle to diagnose and combat the spread of influenza pandemics. Morgan West, New Product Development Lead at BBI Solutions and one of the inventors of the Morffi technology said in a press release: “Each year in the United States, seasonal influenza leads to between 140,000 and 710,000 hospitalizations and as many as 56,000 deaths. This is a devastating disease that has been a constant threat for hundreds of years. Developing diagnostics that provide an accurate, rapid diagnosis of the virus is the first and most crucial step to tackling this global threat. Exploring and adopting new technology and approaches offers us the best possible chance of tackling influenza.” Press Release
Nanobiotix announced that it is launching a research collaboration with Weill Cornell Medicine to begin nonclinical studies of NBTXR3’s mechanism of action. NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system. The research collaboration between Weill Cornell Medicine, based in New York City, and Nanobiotix will be conducted over the course of one year, with the goal of continuing the exploration of the role of NBTXR3 in Immuno-Oncology. The main objective of this collaboration is to study the impact of NBTXR3 activated by radiotherapy on the cGAS-STING pathway using different in vitro and in vivo murine models (mammary). Along with immunogenic cell death, the cGAS-STING pathway has emerged as the key component of the anti-tumor immune response. Data generated from this collaboration could support current evidence indicating that NBTXR3 activated by radiotherapy can increase the anti-tumor immune response, compared with radiotherapy alone, and transform an irradiated tumor into an efficient in situ vaccine. Press Release
Karius announced that the new version of its proprietary Karius Test can now quantify the abundance of pathogens detected. The test uses next-generation sequencing of microbial cell-free DNA (cfDNA) to identify over 1,000 pathogens from a single blood sample. Results are typically delivered the next day. Karius is making the test immediately orderable to physicians nationwide. The Karius Test uses next-generation sequencing (NGS) to enable broad and rapid detection of bacteria, DNA viruses, fungi and protozoa in one broad-based test for infectious diseases. With a standard blood draw, the test identifies cell-free DNA (cfDNA) fragments left by microbes in a patient’s bloodstream, even when living organisms are no longer detectable in the blood or when patients have been pre-treated with antibiotics. Karius reports the presence and abundance of microbial cfDNA to physicians when statistically significant levels are detected above background. “The new quantitative capabilities we added to our test give clinicians even greater insight – now not only delivering answers on which pathogens are present, but also the extent of the infection, enabling doctors to make more informed treatment decisions,” said Karius CEO Mickey Kertesz in a press release. “We are committed to delivering the highest quality service for clinicians to more rapidly diagnose infectious diseases, helping save lives in the most challenging diagnostic dilemmas including immunocompromised patients, complicated pneumonia, culture-negative bloodstream infections and invasive fungal infections.” The Karius Test has been commercially available for over a year and has helped clinicians accurately detect pathogens in diagnostically challenging situations, including sepsis, endocarditis, fever of unknown origin, and in patients who have received antibiotic pre-treatment. It has also been useful for hematologist-oncologists who actively monitor immunocompromised patients susceptible to a broad range of pathogens, including stem-cell transplant recipients. Press Release
Exosome Diagnostics has continued to make significant progress in expanding contracts to provide laboratory services and ExoDx Prostate(IntelliScore) (EPI) testing through both public and private payers in the United States. Contracts executed in March and April 2018 have increased total covered lives from 82 million to 110 million plan members across the United States. This increase is based on a series of coverage decisions from regional private payers where we are marketing our EPI test. This includes association member plans, independent community plans and state Medicaid programs. The company is advancing contracting decisions with a number of additional payers across the United States and expects to announce additional coverage determinations over the remainder of 2018. Press Release