News Briefs

The North Shore-LIJ Health System and OPKO Health formed a strategic alliance to provide genomic testing, molecular diagnostic testing, and support services such as genetic counseling.  The scope of testing will cover all genetic disorders, including prenatal screening, pediatric and postnatal diagnosis, assessing risk for inherited cancer, and testing for genetic cardiac abnormalities and neurological disorders.  It will also include genetic analysis of cancer for sensitivity to drug therapies. A new limited liability corporation related to the partnership will generate knowledge from a shared data infrastructure consisting of fully annotated genomic data with detailed clinical information, with the aim of gathering evidence on the medical value of genomic and genetic testing. Press release

Novogene and Illumina entered into an agreement to jointly develop clinical applications in reproductive health and oncology based on next-generation sequencing (NGS) technology. In particular, the two companies will work together to develop a user-friendly diagnostic system for clinical prenatal DNA and oncology testing in the Chinese market. Novogene will provide its nucleic acid extraction, library preparation, and data analysis software, while Illumina will provide NGS instrument components and related reagents. Press release

Ethical GmbH and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a strategic partnership. The collaboration, which brings Ethical GmbH into the ACRES Alliance, focuses on improving data quality and processes in clinical research through standardization efforts in endpoint adjudication. Ethical GmbH will integrate its Ethical eAdjudication Platform into ACRES’ shared global platform. Ethical GmbH and ACRES will also explore development of shared standards across service providers, stakeholders managing Endpoint Adjudication Committees, and sponsors. (For more on ACRES, see, “ACRES to Produce Global Accreditation Standards for Trial Sites.”) Press release

Quintiles launched its Integrated Asset Development Plan (IADP) offering. The new suite of services combines development and regulatory strategy with therapeutic knowledge, data analytics and modeling. As part of the IADP offering, Quintiles advises biopharmaceutical companies on considerations for an asset’s value proposition, Target Product Profile, regulatory plan, and a Clinical Development Plan. The IADP also includes market access planning, evidence generation plan, commercial launch plan, lifecycle management and real-world evidence risk management plans, in keeping with the stage of development for the asset. Press release

Luminex Corporation received FDA clearance for its NxTAG Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The panel simultaneously tests for all 20 pathogens in a single closed tube system, and requires only minutes of hands-on time with no upstream reagent preparation. Laboratories can process a single sample or up to 96 samples per run without wasting consumables or reagents, in order to scale throughput for seasonal infections. The accompanying SYNCT Software provides data analysis and reporting. Press release

Sophia Genetics closed a $15 million Series C financing round led by Alychlo. The funds will be used to continue Sophia’s market expansion and broaden its range of genomic tests. Sophia Genetics now supports more than 100 healthcare institutions across 20 countries with the analytics platform Sophia DDM to analyze the genetic make-up of some common cancers and inherited conditions. Press release

Boehringer Ingelheim selected Medidata’s Clinical Cloud for use in its drug development programs. The platform provides study planning, data management, data analytics and risk-based monitoring (RBM) capabilities. Boehringer Ingelheim will also use one of Medidata’s turnkey clinical analytics offerings, Medidata Insights, which provides metrics, visualizations, and industry data and benchmarks. Press release