November 27, 2019 | November featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Proscia, Vela, Certara, and more.
Proscia announced the Fall 2019 release of its Concentriq platform, along with a global collaboration with Dell Technologies, to help life sciences companies accelerate the adoption of digital pathology at an enterprise scale. Today’s news includes significant product enhancements for more easily managing massive multi-site studies on the Concentriq platform, which is now optimized for cost, scale, and support with Dell Technologies’ enterprise solutions. Life sciences organizations have been on the forefront of digital pathology adoption in an effort to better incorporate pathology data into research and development. While they have amassed millions of images and volumes of associated clinical information, this data largely remains siloed, inaccessible, and dissociated from broader R&D efforts. Proscia introduced the Concentriq image and data management platform to help life sciences organizations adopt and scale digital pathology across the enterprise. The Fall 2019 release extends Concentriq with new capabilities that drive consistency across pathology data for improved efficiency, visibility, and scalability. With this standardization, pharmaceutical, biotechnology, and contract research organizations (CROs) can streamline the launch and management of concurrent studies involving millions of images across multi-site, multi-role organizations. Press release
Vela Diagnostics announced today that it has received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first and only HIV-1 genotyping NGS assay currently available on the market to receive marketing authorization from the FDA. “The granting of the De Novo designation of our NGS assay by the US FDA is a major milestone in HIV diagnostics. Vela strives to bring relevant products to clinicians to help patients around the world. With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” Sam Dajani, acting CEO & Chairman of the Board, said in a press release. The Sentosa SQ HIV-1 Genotyping Assay is validated on the Sentosa NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with seamless LIS integration and connectivity. Press release
Sheba Medical Center and Ikonisys announced the signing of a partnership agreement for the development of novel proprietary Circulating Tumor Cells (CTCs) tests, targeting specific cancers. The tests and applications will be aimed at a variety of potential clinical purposes, including treatment monitoring (the detection of disease recurrence) and companion diagnostics. Ikonisys will play an integral role within Sheba Medical Center's ARC innovation hub, which is accelerating and redesigning global healthcare through collaboration. The circulating tumor cells detection test possesses the ability to detect, quantify, and analyze tumor cells in the blood of cancer patients. With application in determining disease status, rate of disease progression and predicting the likely efficacy of a particular therapy or treatment, CTC analysis has great potential to transform the cancer diagnostic landscape. However, it has been limited so far by the difficulty in finding these extremely rare cells, that can be as few as 10 out of millions in a typical 10ml blood sample. The automated scanning and analysis capabilities of the Ikoniscope platform allow the efficient screening of a much larger number of cells than would be possible by manual analysis, allowing the identification and enumeration of CTCs in the blood of cancer patients with high sensitivity and specificity. Sheba's research team, led by Prof. Iris Barshack, will identify and propose biomarker panels for specific cancers of particular interest that will be evaluated as potential new Ikoniscope CTC tests. All available clinical data will be collected for the patient samples being tested, including, for example, other available liquid biopsy data. This will allow evaluation of the potential complementary nature of cell-based CTC tests, such as performed on the Ikoniscope, for characterization of individual tumor cells, compared to circulating DNA-based tests that provide global tumor genotype information. Press release
Certara announced the availability of PK Submit, a technology solution for automating the creation of PK Clinical Data Interchange Standards Consortium (CDISC) domains during Non-Compartmental Analysis (NCA). The US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) both require that CDISC study data standards be applied to preclinical and clinical data submitted electronically as part of a new drug application (NDA). “As the number of clinical trials being conducted has grown tremendously, it is spurring an equally dramatic increase in the number of new drug and biologics license applications being filed,” said Michael Eckstut, senior vice president and head of Certara’s pharmacometrics software group, in a press release. “It is now more important than ever that sponsors have access to tools that can automate standardized, manual processes, such as the creation of CDISC files, thus increasing accuracy, improving data organization, and ensuring compliance. Our clients are also finding significant time reductions, thus shortening the time to file regulatory submissions.” CDISC guidelines apply to all new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications. PK CDISC domains are required when developing the preclinical Standard for Exchange of Nonclinical Data (SEND) and clinical Study Data Tabulation Model (SDTM) datasets needed for a regulatory submission package. Press release
XACT Robotics announced the appointment of Brian L. Allen as Vice President of Sales and Marketing. A proven commercial executive in medical robotics, Brian brings more than two decades of MedTech leadership delivering multiple first-to-market transformative medical device technologies including, amongst others, the successful launch of MAKO Surgical Corp. robotic system, positioning the company as pioneers and global leaders in its space (until its acquisition in 2013 by Stryker). “We’re excited to have Brian lead our accelerated commercialization focus and efforts,” Harel Gadot, Executive Chairman and President, XACT Robotics, said in a press release. “Brian’s medical robotics pedigree, proven leadership in building successful provider and healthcare system partnerships, and track record of scaling numerous MedTech disruptors, will prove invaluable as we establish XACT Robotics as the global leader in medical robotics.” Brian recently served as Senior Vice President of Business Development for HeartSciences, where he led the global market release of the cardiac industry’s first wavelet signal processed electrocardiogram with AI machine learning. Previously, Brian served as Vice President of Sales and Commercial Marketing for OrthoSensor, where he launched the orthopedic industry’s first sensor-assisted instrument for total knee replacement surgery. Most notably, Brian served as the Director of Sales and Marketing for MAKO Surgical, establishing its to-market strategy, building and leading its commercial team and scaling its year-over-year revenue, resulting in its acquisition by Stryker for $1.65 billion. Brian holds a Bachelor of Arts (BA) from Western Michigan University as well as executive education from the Sloan School of Management at the Massachusetts Institute of Technology. “I am excited to dive into this unique opportunity, and join XACT Robotics at this pivotal time as we redefine what the future of medical robotics should become with the first hands-free robotic system,” Allen said in an official statement. “I look forward to bringing the XACT Robotic System to market, a technology that will no doubt empower providers to realize a higher clinical, technical and economic potential while restoring health and improving the quality of life for the patients they serve.” Press release