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Molecular Health, DNAe Both Launch Collaborations on Personalized Treatment for Cancer, More

October 29, 2021 | Roche and Ibex Medical Analytics launch AI pathology agreement, University of Warwick and Iceni Diagnostics take a new look at SARS-CoV-2 testing, Caris Life Sciences and Ono Pharma collaborate on liquid biopsy, and wearables for cardiac health. Plus new products from MIP Diagnostics, AliveCor, Bio-Rad, and more.

Together with Imperial College London (‘Imperial’), DNAe has been awarded a UK Knowledge Transfer Partnership (KTP) by Innovate UK to support development of its next generation sequencing (NGS)-based diagnostic platform for use in cancer monitoring. The KTP program connects innovative businesses with academic experts who can help them deliver their ideas. This award formalizes a collaboration between DNAe and Professor Charles Coombes, Professor of Medical Oncology at Imperial. The aim of the program is to develop a ‘liquid biopsy’ test based on DNAe’s proprietary “sample to answer” NGS technology, to directly detect and identify biomarkers and mutation hotspots that have been identified in Professors Coombes’ and Shaw’s research. This will enable these markers to be used to monitor treatment and detect early recurrence of breast cancer. Under the terms of the partnership, a post graduate researcher (the KTP Associate) will be based at DNAe to integrate expertise from the academic partners into the development of the test. Press release.

MIP Diagnostics, a leader in the field of Molecularly Imprinted Polymers (MIPs), has announced the launch of its novel Molecular Imprinting Epitope Discovery Service for the identification of previously unknow protein surface epitopes. MIP Diagnostics has developed, in conjunction with the group of founding inventor Sergey Piletsky at the University of Leicester, a novel method of utilizing its technology for the discovery of previously unknown epitopes on the surface of a protein, prior to initiating an affinity reagent development rather than at the end. This new technique will provide valuable insights on surface epitopes with potential antigenic properties prior to the development of new affinity reagents, increasing the chances of success. Delivering results in as little as two weeks, the process is significantly faster than traditional epitope mapping technique and allows affinity reagent manufacturers to avoid the ‘antibody lottery’ when tackling some of the most challenging diagnostic markers. Press release.

Solve.Care and AliveCor have partnered to enable users of AliveCor’s KardiaMobile devices and services to easily book teleconsultations with physicians on the Global Telehealth Exchange (GTHE) network. Through this partnership, physicians on the network will be able to seamlessly access users’ KardiaMobile electrocardiogram (ECG) readings, upon their consent. The KardiaMobile 6L device is the first and only six-lead personal ECG cleared by the US Food and Drug Administration (FDA). It detects more arrhythmias than any other personal ECG device. GTHE is an open global cross-border telehealth network that enables doctors and patients to connect worldwide. The partnership will see KardiaMobile devices integrated with Solve.Care’s blockchain platform to enable its users to connect with a physician on GTHE directly through the Kardia app to share their ECG readings during their teleconsultations. As physicians have access to previous ECG readings stored by KardiaMobile, this will provide physicians with a more complete understanding of the patient's symptoms to facilitate more effective ongoing care. As GTHE is built using blockchain technology, all data is fully secured and remains in control of the patient. Press Release.

Bio-Rad Laboratories has launched the CFX Opus 96 Dx System and the CFX Opus 384 Dx System, real-time PCR detection systems that have been listed with the U.S. Food and Drug Administration (FDA) for IVD testing and that meet the CE-IVD requirement for IVD use in Europe. Both systems are also registered with regulatory bodies for IVD use in Singapore and Canada. The CFX Opus 96 Dx System and the CFX Opus 384 Dx System are the latest additions to Bio-Rad’s portfolio of real-time PCR instruments. The systems offer accurate and precise quantification to improve assay development and workflow efficiencies and productivity for diagnostic testing and research. The CFX Opus 96 Dx Real-Time PCR System and the CFX Opus 384 Dx Real-Time PCR System are open systems that can multiplex up to five targets to provide efficient IVD assay development and testing. The systems provide precise quantification, improved thermal cycler performance, and easy-to-use desktop management and analysis software with integrated security features. Press release.

Vivacare is partnering with Asthma and Allergy Network to provide a digital patient education service to their 18,000 professional members, including allergists, dermatologists, pediatricians and primary care providers. AAN members who enroll for the service receive a personalized “Patient Education Toolkit” pre-loaded with in-depth disease education resources, including printable handouts, videos, and patient support tools that can be easily distributed to patients via print, email, text or displayed on the provider’s own website. The service makes it easy for health care providers to deliver doctor-recommended health information to their patients to help them prepare for their appointments and manage their condition from home. AAN members will receive patient education resources from Allergy and Asthma Network, including a range of titles covering asthma, eczema and other allergic conditions. The patient education service also enables physicians to share their own clinical expertise with patients by publishing their own patient handouts or “Tips & Wisdom”—quick thoughts on clinical issues of importance to patients. Press release.

Molecular Health and the life science company Gen Era Diagnostics have signed a collaboration agreement to optimize the personalized treatment of patients with cancer. For this purpose, Gen Era will provide the MH Guide software platform to twenty laboratories in Turkey to use in the interpretation of tumor data. Gen Era Diagnostics is one of the leading product and service providers in the field of molecular diagnostics in Turkey. Founded in 2013, the company supports scientists, clinicians, and laboratories in the investigation of diseases and the treatment of patients. Gen Era’s offering includes solutions and services for molecular diagnostics in the fields of oncology, cardiology, and metabolic diseases, among others. In addition, the company offers services for the life sciences, including genomics, proteomics, and cell analyses. MH Guide is an analysis software for interpreting molecular data from cancer patients. It summarizes in a report the relevant genetic changes of a tumor that can be specifically addressed in individual patients either therapeutically or in clinical trials. In this way, treatment options can be expanded, especially for patients with metastatic disease. Press release.

Royal Philips has launched Philips Pediatric Coaching, a holistic solution designed to be a less stressful experience for parents and their children undergoing MRI scans. Using gamification and ‘buddy system’ techniques to prepare children and their parents beforehand, the solution helps guide young children through the MRI procedure to significantly enhance the patient experience. Pediatric Coaching is the latest initiative launched within the Philips Ambient Experience portfolio, featuring a wide range of dedicated solutions to help enhance the experience of patient and staff. Press release.  

Roche has entered an agreement with Ibex Medical Analytics, a global leader in artificial intelligence (AI)-based cancer diagnostics. Under the agreement, the companies will jointly develop an embedded image analysis workflow for pathologists to seamlessly access Ibex’s AI algorithms, insights, and decision support tools using NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software. Collaborations with leading AI companies like Ibex are made possible through Roche’s Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche’s growing menu of AI-based image analysis tools. Ibex’s Galen platform was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) and is CE marked in Europe for breast and prostate cancer detection in multiple workflows. Through this alliance, customers using Roche Digital Pathology will gain access to Ibex’s innovative tools, such as algorithms that analyze prostate and breast biopsies, in addition to the AI tools already provided by Roche. Press release.

Researchers at the University of Warwick, Iceni Diagnostics, and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust have demonstrated their technology to detect SARS-COV-2 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to provide rapid identification of people with an active infection. These LFDs work by using antibodies, which ‘stick’ to the SARS-COV-2 virus. Professor Matthew Gibson’s research team at the University of Warwick have been working with Iceni Diagnostics to develop an alternative system of detection using glycans (‘sugars’), where synthetic polymer chains are used to attach the glycans to the surface of nanoparticles. Viruses commonly use glycans as a ‘handle’ to attach to our cells, with the team mimicking this process to enable detection of SARS-COV-2. Working with UHCW NHS Trust, the team demonstrated that prototype devices could identify COVID-19 positive swabs across a range of viral loads. The team also showed that the technology functioned well with the spike proteins from variants of concern, which is a key benefit of using glycan-binding technology. Press release.

Caris Life Sciences, and Ono Pharmaceutical Co., an R&D-oriented pharmaceutical company committed to novel drug discovery and development, announced a strategic collaboration to leverage Caris’ best-in-class molecular profiling, including its novel, liquid biopsy circulating nucleic acids sequencing (cNAS) assay, across several studies beginning later this year. Under the terms of the agreement, Caris will provide comprehensive molecular profiling analysis in support of several Ono clinical studies evaluating a range of targeted and immune-based therapies, including an initial phase III trial, and others to be named at a later date. Caris’ cNAS molecular profiling assesses all 22,000 genes across DNA and RNA from blood, which are unique to an individual’s cancer, to reveal a molecular blueprint in order to guide more precise and individualized treatment decisions. Press release.

Pearl has announced that it has received authorization to introduce its Second Opinion AI solution to the Australian and New Zealand dental markets. The clearances from Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medical Devices Safety Authority (MEDSAFE) follow the European CE marking Second Opinion received earlier this year for use as an assistive tool in dental radiology. The new clearances signal growing recognition of AI’s utility in clinical dentistry. Pearl developed Second Opinion to aid dentists in their evaluation of patient x-rays. The tool applies radiologic computer vision to highlight potential areas of interest, giving dentists a second set of eyes when reading x-rays—both to help dentists ensure that patient care decisions are based on the strongest foundation possible and to give dentists a new level of assurance when communicating findings to patients. Press release.

RAYUS Radiology, formerly Center for Diagnostic Imaging, a leading national provider of advanced diagnostic and interventional radiology, has acquired Diagnostic Centers of America (DCA), a leading radiology provider with centers in West Palm Beach, East Boca Raton, West Boca/North Broward, Wellington, East and West Boynton Beach, Delray Beach and a newly opened location in Palm Beach Gardens. DCA's radiology services are provided by subspecialized radiologists with the Boca Radiology Group (BRG), which conducts more than 550,000 procedures annually. For RAYUS Radiology, the acquisition of Diagnostic Centers of America is its eighth acquisition, growing from 123 centers to 148 centers nationwide in the past 12 months, as part of its aggressive growth that has followed Wellspring Capital Management's acquisition in March 2019, and the recruitment of Kim Tzoumakas as CEO in March of this year. Press release.

Genedata and Egis Pharmaceuticals are collaborating to develop a precision medicine tool for rheumatoid arthritis. Recognizing the urgent need for an advanced precision therapy that provides a more effective treatment for this debilitating disease, Egis has developed the PREDYSTIC Infliximab RA Kit, which received the CE In Vitro Diagnostic (IVD) Medical Device Certificate on December 21st, 2020. The kit is based on gene expression biomarkers that can help to differentiate between responders and non-responders to infliximab before treatment initiation. The PREDYSTIC Infliximab RA test even predicts the Disease Activity Score (DAS28 CRP) for the 6th month of the treatment. As part of the collaboration, Genedata has provided Data Science services to Egis, leveraging the power of Genedata Profiler, the firm’s market-leading enterprise software for the harmonization, integration, management, and analysis of multi-omics, biomarker, clinical, and phenotypic data derived from translational and clinical research. Press release.

Biotricity has announced the upcoming release of Biocare Cardiac, a personal, cardiac health application for individuals diagnosed with or at risk for cardiovascular disease. Designed to be used with Samsung's Galaxy Watch4 series, the Biocare Cardiac application continuously collects users' daily activities and provides critical information on their heart performance, empowering patients to better understand and manage their heart conditions. This new application is designed to be used as part of Biotricity's complete cardiac solution, which includes Biocare Telemed, Bioflux Diagnostics, Biokit, Bioheart, and the Galaxy Watch4 Series. Press release.