News Briefs

Emperra, creator of a digital diabetes management solution, completed a Series B financing round of $3.1 million, with Robert Bosch Venture Capital GmbH joining existing investors Peppermint VenturePartners and Investitionsbank des Landes Brandenburg. Emperra’s flagship product is ESYSTA, which includes smart insulin pens, wireless blood glucose meters, and CE-certified software. ESYSTA data can be shared between patient, physicians, nurses, and caregivers and displayed via multiple channels, including a web-based portal, smart TV, and apps. Press release

BC Platforms signed a partnership with Auria Biobank to develop a genomic data management system. Auria Biobank, the first clinical biobank in Finland, links millions of human tissue samples to data from hospital records and National Health Care registers. BC Platforms will implement a system to integrate sample management with real-time clinical information and genomic data, and will assume responsibility for its ongoing maintenance. Press release

Illumina filed two patent infringement suits in Europe, regarding the use of cell-free fetal DNA for non-invasive prenatal testing (NIPT). The suits concern the use of Ariosa’s Harmony NIPT test by The Doctors Laboratory in the United Kingdom, and Premaitha Health’s Iona NIPT test by multiple labs in Poland. Illumina is also engaged in ongoing suits against both Ariosa and Premaitha. Press release

Cynapsus Therapeutics and The Michael J. Fox Foundation will work together to incorporate wearable device technology into Cynapsus’ Phase 3 clinical study of the experimental drug APL-130277. This is a pilot effort to understand how clinical studies can harness data science approaches to objectively measure disease progression in Parkinson’s disease. The project builds on MJFF’s ongoing data science partnership with Intel Corporation, launched in August 2014, to develop platforms for the storage of large volumes of patient-generated data and algorithms to glean insights from this data. Press release

Sophia Genetics opened a research and development wet laboratory at Campus Biotech in Geneva, Switzerland. Sophia will use this new facility to test its machine learning algorithms against new cases of complex genomic alterations with a broad range of biological samples and across a number of wet lab technologies. Sophia’s flagship product, Sophia DDM, is used in clinical centers to analyze patients’ genetic make-up for common cancers and inherited conditions. Press release

Epic Sciences selected the GenePool platform created by Station X to share genomic data with pharmaceutical companies developing companion diagnostics based on Epic’s circulating tumor cell

(CTC) technology. Epic Sciences is involved in more than 58 active clinical trials with over 35 pharma partners, as well as several research collaborations to better understand metastatic disease heterogeneity across multiple disease indications. Press release

Medivation and NanoString Technologies entered into a collaboration, together with Astellas Pharma, to create a companion diagnostic that incorporates both a novel gene expression signature algorithm from Medivation, and NanoString’s nCounter Dx Analysis System. Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test, and is eligible to receive up to $22 million in various milestone payments. The companion diagnostic will be used to screen patients’ eligibility for enzalutamide in cases of triple negative breast cancer. Press release

Korean biopharmaceutical company Celltrion adopted Medidata’s Clinical Cloud platform for use in clinical trials. Celltrion is particularly focused on creating affordable biosimilar monoclonal antibodies to compete with patent-expired biologic drugs. The company will use Medidata software for electronic data capture and management, medical coding, and randomization and trial supply management. Press release

New Products

Ambry Genetics launched Progeny Cloud, which is used to manage patients’ pedigrees and family history data in order to identify genetic risk factors. Progeny Cloud is a cost-free version of Progeny Clinical, which Ambry acquired in April 2015. The platform’s Family History Questionnaire feature lets patients themselves build detailed records of their health history, and this information is integrated with genotype data and laboratory testing. Press release

Bioclinica created a Post-Approval Research division of its Global Clinical Research business segment. The new service will design and execute post-approval research for large, simple trials; complex post-approval safety studies; and patient-centric post-marketing studies. It includes a new technology platform that offers full access to real-time study metrics. Bioclinica provides global operational infrastructure from centralized locations to support local languages and time differences. Press release

Definiens released the Tissue Studio 4.2 software package, an upgrade to its flagship tissue imaging analysis platform. The updated product includes a TMA brightness slider for improved TMA core detection, and improved needle biopsy registration to allow more accurate transfer of the regions of interest between consecutive slides. Tissue Studio 4.2 also provides the ability to create “Heat Maps” based on combinations of readouts and object features, for more precise visual review of the local distribution of biomarker expression―for example, when imaging immune cell populations in the tumor microenvironment. Press release

IDBS unveiled E-WorkBook Connect, a secure portal for R&D organizations to collaborate with external partners. A module of IDBS’ E-WorkBook software, the cloud-based tool provides a space for users to coordinate project activities, handle assay data and documents, and discuss or review content. The tool feeds data from third-parties back into internal corporate systems, without granting access to private corporate content. Press release

RPS Diagnostics received a Medical Device License from Health Canada for FebriDx, a rapid, in-office test that uses a fingerstick blood sample to help identify immune responses to viral and bacterial acute febrile respiratory infections. Disposable FebriDx tests are designed for use by a nurse or technician during a patient’s initial workup, and report results within 15 minutes. They detect elevated levels of two proteins found during acute viral and bacterial infections, respectively. The FebriDx test is already CE marked and available for sale in Europe, but has not yet received clearance from the U.S. FDA. Press release (PDF)