August 29, 2018 | August featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Exact Sciences, Fuzionaire Dx, Splice Machine, and more.
Executives from Exact Sciences and URP broke ground on a new, 138,000 square-foot building, named Innovation One, located between 441 Charmany Drive and 501 Charmany Drive. The building will serve as Exact Sciences' corporate headquarters from which the company will continue its work to eradicate colorectal cancer and combat other cancers through early detection. When complete in early 2020, the building will unite team members and departments currently dispersed across multiple sites in the Madison area. "From our headquarters, Exact Sciences will continue to lead the war on cancer through early detection," said Kevin Conroy, chairman and CEO of Exact Sciences, in a press release. "Our product pipeline is strong and we expect this site to be home to new breakthroughs in cancer screening and diagnostics that will better the lives of people around the world." Since relocating to Madison from Boston in 2009, Exact Sciences has grown from a handful of employees to more than 1,600. Approximately 1,200 of those employees are based in the greater Madison area. The company's new headquarters building reflects the master plan for URP, which favors walkability and urban density to promote collaboration and more vibrant workspaces. URP expects Exact Sciences' presence and employee base to serve as a catalyst for other development in and around the park. Press release
Fuzionaire Diagnostics launched its proprietary radiolabeling platform. Leveraging a fundamental breakthrough in alkali metal catalysis, Fuzionaire Dx is helping clinicians and researchers study and cure debilitating diseases, earlier, and with unprecedented precision. The platform is able to radiolabel any molecule at record-breaking speed, resulting in lower-cost, more targeted, and more effective radiopharmaceuticals. Fuzionaire Dx's patented method makes it possible to create fluorine-18 radiopharmaceuticals that contain a novel class of stabilized silicon-fluorine bond, a process that is much more efficient and uses existing radiochemistry infrastructure. These efficiency gains not only lower costs, they dramatically reduce the time it takes to prepare radiotracers. This is vital given the short (i.e., 109.8 min) half-life of the fluorine-18 radioisotope. As a result, molecular imaging techniques like PET will be able to image a much broader range of biological targets and a greater breadth of diseases. This radiolabeling method also reduces the amount of off-target imaging and produces images with greater specificity and image clarity. "Until now, no platform has existed to radiolabel any ligand with fluorine-18, and especially not with our speed," said co-founder and CEO Nick Slavin, in a press release. "We've developed a tool that will both enable the non-invasive diagnostic imaging market to enter a new era, and accelerate drug discovery programs to allow pharmaceutical companies to more effectively develop breakthrough therapies." The company is starting with diagnostics, where PET imaging is already used in the clinic for oncological, cardiovascular, and neurological applications to study, monitor, diagnose, and treat debilitating diseases. Press release
Certara announced the launch of D360 v10.5, the first in a series of releases focused on delivering biologic-relevant tools together with D360’s world-class data access capabilities. This latest release of Certara’s D360 self-service data informatics platform upgrades the efficiency and consistency of data-driven biologics research workflows for drug discovery scientists, adds a new multi-parameter scoring capability, and improves data analysis and visualization across all modalities. With the advent of recombinant DNA technology and biomanufacturing, therapeutic discovery projects increasingly center on biologic modalities, especially oligonucleotides. The worldwide biologic drugs market is estimated to be valued at more than $200 billion, growing at a rate of 10% per year. While informatics systems for capturing biologics data are maturing, scientists often lack the tools required to understand and prioritize these entities efficiently, relying on manually-curated spreadsheets for crucial decision making. “While many of our customers use D360 for biologics and small molecule research already, this latest release delivers discovery tools that significantly strengthen the platform’s oligonucleotide capabilities and workflows. We have also incorporated feedback from thousands of D360 users to fine-tune workflows and usability across modality types, allowing scientists to focus on the data and science instead of the software they are using,” said David Lowis, senior director of D360 at Certara, in an official statement. Press release
Tianjin Novogene Bioinformatics Technology Company recently received CFDA approval for its NovoFocus NSCLC CDx Test. This is a next-generation sequencing (NGS)-based diagnostic test that simultaneously analyzes tumor samples for multiple genomic mutations associated with several CFDA-approved targeted therapies for non-small cell lung cancer (NSCLC), which accounts for ~80% of all lung cancers in China. The NovoFocus NSCLC CDx Test was developed on the Thermo Fisher Ion Proton sequencing platform (approved by CFDA as “DA8600” in January 2017 for the diagnosis of cancer and inherited diseases). The reagent kits for sample processing and library construction, as well as the data analysis and result reporting software system, were developed by Novogene. Following this CFDA approval, results from the sequencing and analysis of three genes, EGFR, ALK and ROS1, can be used to identify NSCLC patients who may be eligible for treatment by CFDA-approved targeted therapies Gefitinib (IRESSA), Osimertinib (TAGRISSO) and Crizotinib (XALKORI), respectively. Results on the other three genes, KRAS, BRAF, and PIK3CA, can be considered by clinicians together with other test results and the patient’s disease characteristics during clinical decision making. Press release
Splice Machine announced that Precision Innovation Network (PIN) has selected Splice Machine's intelligent data platform to develop its Treatment Advisor prototype. The application will leverage multi-dimensional data and machine learning to help clinicians learn the trajectory of a disease and gather predictions for what may be the best treatment for each individual. It also allows doctors to analyze the data to target disease-modifying therapies and better understand how a patient might feel – what the medical community calls a patient-reported outcome (PRO) – in the future. Growth in the AI health market is expected to reach $6.6 billion by 2021— and, according to Accenture, the combined deployment of key clinical health AI applications can potentially create $150 billion in annual savings for the U.S. healthcare economy by 2026. "Machine learning performed on rich, multidimensional data has massive potential to improve both medical care and patient outcomes," said Monte Zweben, CEO of Splice Machine, in a press release. "However, the vision for such systems has been hindered by complex, costly data platforms. We're thrilled to be working with PIN, along with clinical leader and innovator Mark Gudesblatt, to provide an integrated, scalable platform for doing data science on neurological data." Splice Machine will provide PIN with a data science workbench for the ingestion of data, the visualization and transformation of the raw data to apply machine learning to the data, and a view of the insights that will help provide more precise medical treatment to patients. The Treatment Advisor will be delivered on Splice Machine's AWS-hosted cloud service. Press release