June 25, 2020 | June featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including PerkinElmer, MeMed, Genomenon, and more.
PerkinElmer announced the addition of the DELFIA Xpress sFlt-1 kit to its CE-IVD pre-eclampsia product offerings. This kit will enable short term prediction of pre-eclampsia and aid in diagnosis in the second and third trimesters of pregnancy together with the previously launched DELFIA Xpress PlGF 1-2-3 assay. It is easily adaptable for current screening customers using the DELFIA Xpress instrument. In the second and third trimesters of pregnancy among symptomatic women, the concentrations of DELFIA Xpress sFlt-1 and DELFIA Xpress PlGF 1-2-3 assays can be used to calculate a ratio to predict the onset of pre-eclampsia and for aid in diagnosis. The addition of sFlt-1 completes PerkinElmer’s pre-eclampsia product portfolio as the Company now offers different solutions for managing pre-eclampsia during all trimesters. “For risk assessment and diagnosis of pre-eclampsia, accurate results enable health care to primarily predict and prevent pre-eclampsia and also to provide improved management for all women,” said Petra Furu, GM, Reproductive Health, PerkinElmer, in a press release. “With the sFlt-1 assay, we offer the ability to better manage and assess this condition throughout all stages of pregnancy, furthering PerkinElmer’s mission of encouraging healthier families and improved prenatal care.” The newly launched DELFIA Xpress sFlt-1 is the latest product to the family dedicated to the prediction of pre-eclampsia that includes PlGF kits on various platforms, as well as the recently launched Pre-eclampsia Detection Kit, the first urinary true point-of-care kit utilizing Congo Red technology. Press release
MeMed announced that it has received a CE Mark in Europe for use of its diagnostic test MeMed BV and point-of-need platform MeMed Key. “At its core, MeMed is about decoding the signals of the host-immune response to help physicians make better informed decisions that improve patients’ lives,” Eran Eden, MeMed’s co-founder and CEO, said in a press release. “The CE-IVD mark brings us closer to impacting patients around the globe. We believe MeMed BV and MeMed Key will be a major addition to the clinical arsenal, improving outcomes for patients with acute infections, lowering healthcare costs and combating antibiotic resistance. We are indebted to the United States Department of Defense and the European Commission for their continuous support, helping us reach this significant milestone, as well as to our research collaborators who are generating an unprecedented amount of clinical evidence in the US, Europe and other regions around the globe.” MeMed BV measures host-immune response proteins from a small sample of blood and applies machine learning in order to accurately distinguish between bacterial and viral infections. This provides actionable information enabling better informed antibiotic and antiviral treatment decisions. By relying on the immune response, rather than direct pathogen detection, MeMed BV complements conventional technologies, allowing rapid and accurate diagnosis even when the infection site is inaccessible. MeMed BV has been validated by a level of high-quality real-world data from over 15,000 patients and multinational, double-blind clinical studies, published in leading peer-reviewed journals, showing over 90% sensitivity and specificity across multiple pathogens. Press release
Genomenon announced the latest release of the Mastermind Genomic Search Engine, which includes enhanced search for intronic and non-coding variants across the medical literature. Mastermind users now receive more specific results when searching the comprehensive database of genomic evidence. Intronic and non-coding variants are notoriously difficult for geneticists and variant scientists to find with search tools like Google or Google Scholar. Unlike missense variants, which sit in the coding region of a gene and can be described by the effect on the gene’s transcribed protein, intronic variants are much more difficult to search for because they have a less direct and well-understood biological effect. With the latest release of the Mastermind Genomic Search Engine, Genomenon increased the specificity of the intronic and non-coding variant search results by prioritizing nucleotide-specific descriptions within the search results. This provides the user with optimal specificity while maintaining maximal sensitivity. By searching at the nucleotide level for non-coding variants, users can now see the most specific results in the top articles returned by Mastermind. Broader sensitivity is delivered with similar intronic variants in the same region further down the search results. Press release
Seven Bridges announced a new partnership with CareDx supporting the CareDx AlloSure 3.0 workflow. The use of the Seven Bridges Platform and Automation products dramatically speed time to results by streamlining analysis workflows, minimizing the number of manual steps required to set up, run and conclude an analysis. AlloSure is the first clinically and analytically validated, non-invasive donor-derived cell-free DNA (dd-cfDNA) test for identifying kidney injury. AlloSure can accurately determine active rejection, enabling better management of kidney transplant patients. Press release
Research Corporation Technologies (RCT) announced that it has acquired and invested growth capital into Translational Drug Development (TD2). The acquisition of TD2 by RCT will be a catalyst to expand and accelerate TD2’s platform of integrated oncology solutions and to position TD2 as the leader in strategic oncology medicine development to assist life sciences companies in this fast-paced time of therapeutic innovation in oncology. “The acquisition of TD2 represents an opportunity for a unique partnership with an outstanding management team and, by providing additional growth capital, we plan to add scale and enable the expansion of TD2’s current offerings,” said Shaun Kirkpatrick, RCT President, in a press release. “TD2 will continue its successful business model of providing focused and comprehensive oncology drug development solutions to rapidly advance products to patients most likely to benefit from these treatments.” Press release
Thermo Fisher Scientific announced that it has expanded its strategic partnership with Agios Pharmaceuticals by adding the co-development of a second companion diagnostic (CDx) for oncology to their existing agreement. The CDx will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System, and will be used globally to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). Vorasidenib is an investigational, oral, brain-penetrant inhibitor of IDH1 and IDH2 mutations that is being developed by Agios and is currently under evaluation in the Phase 3 INDIGO study. Under the terms of the agreement, the companies will collaboratively validate the biomarkers for a test that will be based on Thermo Fisher's Oncomine Precision Assay and used to identify variant-positive patients. Thermo Fisher will retain the rights to commercialize the test globally and will lead filings to seek clearance from the appropriate regulatory agencies. Press release
Thermo Fisher Scientific also expanded their partnership with Daiichi Sankyo, signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher's next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu, a HER2 directed antibody drug conjugate (ADC), which is currently in global phase 2 development for HER2 mutated or HER2 overexpressing NSCLC. The Oncomine Dx Target Test is the first targeted NGS in vitro diagnostic test approved by the U.S. Food and Drug Administration (FDA) for NSCLC. It is designed to evaluate multiple biomarkers associated with cancer and identify patients who are eligible for multiple FDA-approved targeted therapies using a single sample with results available in days. "Our latest partnership with Daiichi Sankyo is focused on helping to solve an unmet medical need for a growing number of patients with HER2-mutated non-small cell lung cancer," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, in a press release. "This agreement underscores our continued commitment to working with global pharmaceutical partners to efficiently identify more patients who may benefit from the latest targeted therapies in their drug pipelines." Press release
The University of Colorado Anschutz Medical Campus, led by CU Innovations, has partnered with serial MedTech entrepreneurs Jonathan Gasson and Sharon Lake to form PreView. PreView's technology focuses on the diagnosis and treatment optimization of prostate cancer. The company's ClariCore System utilizes a patented optical biopsy needle combining both the optical spectra of tissue and machine learning to assess the prostate for cancer in real-time - ultimately minimizing the need for traditional core biopsies. Additionally, the company is developing an algorithm to create a high-definition 3D map of prostate tumors to enable accurate targeted focal therapy to treat cancer lesions. Focal therapy significantly reduces morbidity when compared with the current standards of care of either removing or irradiating the entire prostate. Associate Vice-Chancellor, Biotechnology for CU Anschutz, Steve VanNurden, said in an official statement, "We are encouraged by the positive clinical trial work already completed. A study of over 200 patients at eight sites validated high algorithm accuracy. Launching PreView is a testament to the hard work already completed." The CU Anschutz Office of the Chancellor supported the launch of the company by providing $250,000 in seed funding. Press release
Guardant Health unveiled the GuardantINFORM platform featuring an extensive clinical-genomic liquid biopsy dataset of advanced cancer patients. The GuardantINFORM platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360liquid biopsy test—over 100,000 tests to date. This robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers including non-small cell lung, breast, colon, and prostate. The most notable applications for the GuardantINFORM platform include: Targeted drug development: Identify, characterize, and prioritize cohorts of patients with biomarker-defined cancers and in need of treatment options for potential new drug development indications and label expansions; Clinical trial optimization: Incorporate real-world clinical-genomic data into clinical trial design, control arm simulation, clinical operations activities, and clinical development decision-making; Post-marketing studies: Conduct health outcomes and safety studies of on- and off-label use of marketed therapies using real-world market insights and estimates of progression-free and overall survival in biomarker-defined cancers. Press release
A new program called PATRIOT (PAThway based RNA and DNA Integration with tumor Organoid Testing), developed by the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, is using organoids—laboratory cultures derived from samples of patient tumors—to provide a whole new level of accuracy in prescribing anti-cancer treatments. PATRIOT builds on other precision medicine programs devised by Ashion Analytics, a TGen clinical laboratory, which uses its GEM ExTraproprietary test to match each patient’s unique cancer to the best available cancer treatments. “Cancer tumors are complicated,” said Dr. Sunil Sharma, Deputy Director of TGen Clinical Sciences and Chief of Translational Oncology and Drug Development at the HonorHealth Research Institute. “PATRIOT is a very powerful platform that will make GEM ExTra even more powerful. This will expand the use of RNA analysis in a way that has never been used before.” Press release