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FemtoDx, PGDx, Illumina, and More: News From September 2019

September 27, 2019 | September featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including FemtoDx, PGDx, Illumina, and more.

FemtoDx and Canon Medical announced a capital partnership to revolutionize monitoring for chronic conditions and develop an at-home medical diagnostic test that can detect heart failure and ischemic strokes before they happen. Leveraging extensive research and development, as well as advancements in artificial intelligence and machine learning developed by FemtoDx, FemtoDx will create a product that monitors patients’ biology. The vision is to develop an ultra-sensitive and ultra-specific diagnostic test performed with a portable device in a home setting and supported by mobile connectivity and AI. The test will detect warning signs for heart failure and ischemic stroke by continuously monitoring key health indicators at home with a molecular diagnosis capable of detecting clinically relevant levels at a fraction of the cost and time. “The data we gather will arm healthcare providers with more information needed to make critical clinical decisions in real time for early intervention,” said Raj Mohanty, CEO and Founder, FemtoDx, in a press release. “Both FemtoDx and Canon Medical share the belief that patient care should be personalized and that new technologies can provide peace of mind in a home setting for those with chronic conditions or who are at risk for heart failure or an ischemic stroke.” Press release

A study published by Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR), shows Personal Genome Diagnostics’s (PGDx) liquid biopsy technology successfully detected microsatellite instability (MSI) in circulating tumor DNA (ctDNA), and was able to estimate the likelihood of both an immediate and durable response to immune checkpoint blockade in cancer patients with MSI. The study results point to the value of liquid biopsies as a non-invasive approach to genotyping and monitoring in patients diagnosed with advanced forms of cancer. Researchers from PDGx, Johns Hopkins and Memorial Sloan Kettering Cancer Center, among other institutions, contributed to the study. “Microsatellite instability and high tumor mutation burden (TMB) are promising pan-tumor biomarkers that are used to identify patients who may be candidates for treatment with immune checkpoint blockade,” said John Simmons, VP of Translational Medicine for PGDx, in a press release. “Obtaining samples via tumor biopsy can be challenging in people with advanced cancer, so this liquid biopsy test is a tool that can help doctors select the best therapy for their patients.” Microsatellite instability was the first pan-cancer biomarker approved for determining treatment with the immune checkpoint inhibitor, pembrolizumab. In liquid biopsy testing, MSI status can be determined by evaluating the level of circulating tumor DNA in a patient’s plasma (blood) sample. This study finds ctDNA testing can also help doctors monitor patient response to treatment and identify earlier when a therapy is no longer effective. Press release

Adaptive Biotechnologies announced it has entered into a global agreement with Amgen for the use of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ Assay to assess minimal residual disease (MRD) across multiple drug development programs within the Amgen hematology portfolio. Under the terms of the four-year agreement, Adaptive will receive annual development fees in addition to sequencing payments and regulatory milestones in exchange for providing MRD testing and analysis for ongoing and future clinical trials. “We are excited to continue working with Amgen as their preferred partner to support the development and regulatory approval of novel blood cancer treatments,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies, in a press release. “This pan-portfolio partnership reflects Amgen’s confidence in the role that standardized NGS MRD testing with clonoSEQ plays in demonstrating drug efficacy in clinical trials and in day-to-day patient management.” The partnership, which began in 2016 to assess MRD in acute lymphoblastic leukemia, demonstrates the increasing utility of MRD assessment in the clinic. Adaptive will leverage data generated under this partnership to continue building robust evidence that supports MRD as a validated measure of patient outcomes across multiple novel treatments and blood cancers. Press release

Adaptive Biotechnologies also announced a partnership with Illumina to develop in-vitro diagnostic (IVD) test kits for Adaptive’s current and future portfolio of next-generation sequencing (NGS)-based immunodiagnostics. The test kits under development would expand the availability of Adaptive’s clonoSEQ Assay for assessing and monitoring minimal residual disease (MRD) for the management of patients with certain blood cancers and immunoSEQ Dx Assay for pipeline applications. Clinicians currently order clonoSEQ to monitor MRD as a test performed at Adaptive’s lab in Seattle. The planned IVD test kits will make it possible for hospitals and health systems to run Adaptive’s clonoSEQ and immunoSEQ Dx assays in their local laboratories across the United States. Press release

The first step in developing the next blockbuster antibody therapeutic is isolating a set of high-quality antibody candidates from an immune response. Yet because of the trillions of potential antibodies, it remains an immense challenge for scientists to uncover the rare few that have what it takes to become breakthrough therapies.  Traditional antibody discovery technologies are woefully inefficient and lack the throughput and speed needed to find the few needles that are hidden in the giant haystack of the mammalian immune system. AbCellera has built the industry’s leading discovery platform, a technology that allows for analysis of antibody responses more than 10x faster and 100x deeper than current methods, while at the same time providing more detailed information on the sequence and properties of each antibody. The front end of AbCellera’s antibody discovery is a data mining and visualization tool called Celium. By combining the power of computation with genomics and high-throughput microfluidics, AbCellera can test millions of antibody variants in a single day to uncover the few with desired biological characteristics, increasing the speed of discovery from months to days. By unlocking the diversity of antibody responses, this platform is helping the world’s leading pharmaceutical companies to advance their programs, delivering large numbers of high-quality antibodies and the data needed to predict which ones are suitable for development. Blog post

BioIVT announced that it has joined UK Medicines Discovery Catapult’s Discovery Services Platform, partnering with other best-in-class service providers to help improve preclinical drug discovery success rates. From its GLP-accredited UK facility, BioIVT’s PHASEZERO Research Services team will provide specialist support for generating human tissue-based target validation data and characterizing novel therapeutics. BioIVT’s research into such complex fields as immuno-oncology and fibrosis have given it the necessary experience to successfully validate associated drug targets and biomarkers and aid the development of novel therapeutics with the right balance of efficacy, disposition and safety. “BioIVT is dedicated to supporting the research community by providing expertise in human tissue-based approaches that deliver target and biomarker validation data and by developing fit-for-purpose assays that enable characterization of novel therapeutics to accelerate drug discovery and development,” said Amanda Woodrooffe, Vice President and General Manager at BioIVT UK, in a press release. “We are delighted to join Medicines Discovery Catapult’s Discovery Services Platform and be able to provide our expertise, access to ethically-sourced human biospecimens, and innovative approaches to support UK enterprises.” In addition to its research services capabilities and expertise in the design, execution and delivery of industry-standard drug development data packages, BioIVT can provide ready access to well-characterized, consented human tissues, biofluids and primary cells in many disease areas. BioIVT is another strong and versatile addition to Medicines Discovery Catapult’s Discovery Services Platform. Press release

Inspirata and Ibex Medical Analytics announced a technical partnership providing joint customers with the ability to utilize the IBEX Second Read system directly from within Inspirata’s digital pathology solution as a means to reduce cancer case turnaround times and mitigate diagnostic errors in high-throughput clinical laboratories. Tackling the same challenge from different directions, the combination of their respective workflow and image analysis software sees Inspirata and Ibex meet in the middle to address the nuanced requirements of clinical pathologists at a time of a chronic crisis in European histopathology recruitment which continues to threaten how quickly patients are diagnosed and put forward for treatment. Furnishing clinical laboratories with an immediate means to utilize image analysis to reduce error rates and increase operational efficiencies by analyzing, at scale, prostate biopsy images and identifying cancerous tissues, IBEX Second Read represents the first AI-powered digital pathology system to be deployed in a live clinical setting and is integrated seamlessly into Inspirata’s solution by virtue of the deliberately open design of Inspirata’s architecture. Press release

Elypta is to run the largest ever prospective multi-center study centered on diagnostics in Renal Cell Carcinoma (RCC), the most common form of kidney cancer. At the same time, Elypta announced it has appointed Factory-CRO group, headquartered in the Netherlands, as contract research organization (CRO) to support in the management of the study, named AURORAX-087A (AUR87A). Funded by a Horizon 2020 European Union grant, AUR87A is the first study in the AUROAX series and will evaluate the utility of Elypta’s liquid biopsy platform in the early detection of recurrence in RCC patients after surgery. It is also the first ever study of its kind in urology, collaborating with 16 world-renowned hospitals across the EU and US, under the direction of an equal number of high-profile and field-leading urologic surgeons, who will be acting as study Principal Investigators. The study will initially enroll 140 patients. Elypta is developing a novel liquid biopsy platform for easy and cost-effective early detection of cancer using blood and urine-based metabolic glycosaminoglycan (GAG) markers. Elypta’s platform is comprised of a diagnostic kit, that allows for GAG detection, and cloud-based machine learning software to analyze test results. The platform can be used for a range of cancer diagnostic applications, but the current focus lies on renal cell carcinoma (RCC), the most common form of kidney cancer. Factory is a full-service global CRO specialized in medical device and IVD trials, with headquarters in Bilthoven, the Netherlands. Press release

The National Cancer Institute has awarded a Phase I Small Business Innovative Research (SBIR) contract to Kephera Diagnostics for $299,997 to develop a test for liver fluke infection. The Phase I contract will enable the company to develop a prototype of the test and to evaluate its performance on patients who have been infected with this parasite. Successful results from this evaluation could lead to further SBIR funding for product development and clinical trials. The NCI contract will support Kephera’s efforts to develop a test for liver fluke infection which could ultimately be used to screen Vietnam veterans as well as others who may be at risk for infection based on potential exposure in endemic countries. The test, which will rely on parasite-derived immunological markers, will be developed in both laboratory-based and point-of-care formats to enable testing in a variety of settings, including endemic regions where few laboratory facilities are available. Kephera scientists are planning to work with collaborators in public health and research agencies in Vietnam, who will provide samples to aid in development of the test, which will be carried out in Kephera’s laboratory in the US. Press release

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