February 28, 2018 | February featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Curetis, Cofactor Genomics, Inflammatix, and more.
Curetis announced that Acumen has received approval by the Singapore Health Sciences Authority (HSA) to market the Unyvero HPN Hospitalized Pneumonia Application Cartridge in Singapore. With this approval, Unyvero HPN is now fully registered as a Class C IVD medical device with the Singapore Medical Device Register. After the initial placement of Unyvero Systems under the GN-27 exemption at early adopter sites such as Raffles Hospital, Farrer Park Hospital, and Parkway Laboratories, the HSA approval now allows for a more comprehensive roll-out in Singapore as a bridgehead to the ASEAN region. Acumen expects that the approval in Singapore will facilitate market entry into other countries of the region including Malaysia, Indonesia, and Thailand going forward. The HSA review and approval process for the Unyvero BCU Blood Culture Application Cartridge as a second application for the Singaporean and ASEAN markets is ongoing. Acumen and Curetis further intend to submit the Unyvero ITI Implant and Tissue Infection and Unyvero IAI Intra-Abdominal Infection Application Cartridges for HSA approval. Curetis and Acumen also announced that the development of the Unyvero SHR Sepsis Host Response Application Cartridge for the rapid identification of patients with bloodstream infections and sepsis has been completed. The cartridge is based on a proprietary gene expression biomarker panel licensed by Curetis from Acumen in 2015. In the coming months, the companies expect to initiate clinical validation work on this first cartridge-based rapid molecular test for sepsis alongside a laboratory-developed test (LDT) based on the same biomarker panel already offered by Acumen to hospitals in Singapore. The validation work will focus on demonstrating concordance of the analytical and clinical performance of two tests in the same patient population. Press Release
Cofactor Genomics announced the commercial launch of Paragon, a solid tumor immune-profiling assay requiring only two FFPE (formalin-fixed paraffin-embedded) tissue sections for analysis. Powered by a proprietary database of immune reference signatures, the assay is designed to be cancer type-agnostic and can accommodate any solid tumor specimen, with expression databases pre-built for more than 25 different cancer types. “Building on data from thousands of RNA expression profiles and years of technology development, the Paragon molecular profiling platform offers a unique look into an oncology patient’s immune profile far beyond traditional ‘hot’ or ‘cold’ classification,” said Jarret Glasscock, Founder and CEO, in a press release. “Clinicians and researchers who have been dependent on qualitative, generic characterization from disparate assays such as immunohistochemistry, flow cytometry or expression arrays now have the ability to interrogate nearly all clinical specimens with a sensitivity and specificity previously unattainable. Cofactor Paragon is an invaluable tool to help advance precision medicine.” Press Release
Inflammatix announced findings from a new study published in Nature Communications (DOI: 10.1038/s41467-018-03078-2) that suggest that diagnosing and determining who will likely develop sepsis can be improved with a data-driven approach that measures the immune system response to severe infection. A gene expression model used in the new study is a core component of HostDx Sepsis, a rapid molecular test that Inflammatix is developing to improve sepsis diagnosis. Sepsis, a dysregulated immune system response to infection, kills more than 250,000 Americans and costs the healthcare system more than $27 billion annually in the United States. “Current tools for sepsis identification and triage are imprecise, which often results in patients being overtreated or undertreated and wastes significant healthcare resources. The findings in this new study suggest that measuring immune dysregulation could indicate infection severity and significantly improve sepsis diagnosis,” said Tim Sweeney, lead author of the new paper, and cofounder and chief executive officer of Inflammatix, in a press release. “The technology used in this study forms the basis of our HostDx Sepsis test, which we plan to bring into hospitals and urgent care settings as a rapid test to help reduce the global burden of sepsis.” The new study evaluated gene-based models designed to accurately predict 30-day mortality in patients with sepsis at the time of enrollment. The models were developed and evaluated on over 20 cohorts from clinical studies involving a wide range of populations and settings. Inflammatix holds exclusive license to a pending patent from Stanford University for the institution’s gene expression model from the new study. Press Release
SeraCare announced it is expanding their suite of clinical genomics development, validation, and QC tools with the launch of the SeraseqTM Breast CNV and Seraseq Lung and Brain CNV Mix. Reference materials that analyze for CNVs allow for a complete and comprehensive variant assessment of DNA-based tumor profiling and diagnostic molecular assays beyond SNVs and indels. These expert-designed products are built with innovative biosynthetic technology that is easily scalable to incorporate new CNVs over time. Copy number variations (CNVs) are DNA segments present at a variable copy number in comparison to a normal genome. Cells that are affected by aberrant copy number changes for certain cancer-associated genes may experience disruption of normal cellular function and, ultimately, tumorigenesis. Next-generation sequencing (NGS) can be used to determine CNVs across multiple genes in a sequencing run. In order to help clinical labs performing NGS-based tumor profiling for cancer diseases thoroughly understand and characterize their assays, SeraCare has developed the first set of dedicated CNV reference materials for NGS assays - Seraseq Breast CNV Mix and Seraseq Lung and Brain CNV Mix . These unique products were precisely quantified using highly sensitive digital PCR assays to analyze amplifications of EGFR, MET, FGFR3, MYC, ERBB2, and MYCN genes at +3, +6, and +12 copies against a single well-characterized genomic background (GM24385). Press Release
Codexis announced the appointment of Shawn Clairmont to the newly created position of Senior Director, Molecular Diagnostics. Codexis is expanding into the molecular diagnostics industry by developing and commercializing high-performance enzymes for use in next generation sequencing (NGS) and polymerase chain reaction (PCR/qPCR) applications. Clairmont will be responsible for all commercial activities related to the molecular diagnostics enzyme product line, including product launches and market and pricing strategies. She reports to Michael Aldridge, Codexis’ Senior VP Corporate & Strategic Development. “We welcome Shawn to Codexis as we prepare to commercially launch our first high-performance enzymes for the molecular diagnostics industry,” said Aldridge in a press release. “Shawn brings us significant global experience in product launches and commercial account management as well as established relationships with key molecular diagnostic firms and industry opinion leaders. We look forward to calling upon her expertise in developing successful strategies as we bring new enzymes into this established market.” Clairmont has 13 years of molecular diagnostics industry experience. Most recently she served as Chief Operating Officer of BRIDGenomics, a molecular diagnostics and medical device marketing consultancy providing business development and strategic marketing expertise. She previously served for eight years at the molecular diagnostics company QIAGEN in a variety of positions with increasing responsibility, most recently as Director of Sales, America, on the Global Advanced Molecular Pathology Team. Prior to QIAGEN, Clairmont was a technical marketing representative and account manager at bioArray Solutions. Press Release
Congenica and FutureNeuro announced a partnership to develop new software to deliver faster and more accurate diagnoses in genetic epilepsies. The software will be designed to work with electronic health record (EHR) systems, including the Irish electronic health record for Epilepsy, so that the entire diagnostic process, from initial DNA sequencing to determining treatment options, is available to clinicians and patients through their electronic records. The partnership, operating out of the FutureNeuro Human Genetics lab of Gianpiero Cavalleri in RCSI, Dublin, will build on Congenica's clinical genomics analysis software, Sapientia, to assist clinicians in making more tailored treatment decisions for certain types of genetic epilepsy. The first stage of the project will focus on enhancing the diagnostic potential of the Sapientia software specifically for epilepsy. Sapientia was born out of a pioneering research project at the Sanger Institute; it will be linked with genetic sequencing activities within FutureNeuro to complement Sapientia's existing knowledgebase of high quality epilepsy data. Press Release