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Updated EUAs for COVID Variants, Kidney Disease Diagnostics Could Save Millions, New Products

September 1, 2021 | Budget analysis suggests substantial savings for early kidney disease diagnosis, Harvard-Israel diagnostic partnership, AI for detecting cancer in the GI tract, and update EUAs for Thermo Fisher and Spectrum Solutions. Plus new products from Smart Meter, Dosis, Rhinomed, and more.


BC Platforms and Sentieon have launched their new integrated next generation sequencing (NGS) genetic analytics software, known as BC|GENOME X-10. BC|GENOME X-10 has been developed specifically for commercial laboratories offering NGS data production-based clinical genetic testing following American College of Medical Genetics (ACMG) guidelines or American Society of Clinical Oncology (ASCO) guidelines. BC|GENOME X-10 provides a full end-to-end solution for commercial laboratories to run highly efficient and automated processes enabling high quality testing serving multiple end customers. Press release.

Hyfe, a cough monitoring smartphone app and digital diagnostics tool developed by an international team of scientists and public health professionals, recently announced that their technology is now being incorporated into groundbreaking research in Spain in partnership with the University of Navarra involving over 800 participants. The study will introduce artificial intelligence technology and cough detection smartphone applications into epidemiological research for the first time. This methodology of digital cough monitoring for early detection of respiratory disease outbreaks at a community level has never been performed in research settings before, either in Spain or throughout the world. Press release.

Rover Labs has launched Rover CloudLIS, a proprietary, HIPAA-compliant, cloud-based laboratory information system (LIS). Rover CloudLIS offers diagnostic laboratories and COVID-19 test manufacturers around the world a better way to track and report test results instantly at scale. CloudLIS works with both lab-based, point-of-care, and over-the-counter test systems to manage the entire COVID-19 testing workflow. At sample collection, the test administrator simply scans a QR code and completes a brief digital registration form. As soon as the lab technician processes the sample and determines the result, CloudLIS sends a secure link to the test recipient via email or text. Results can be accessed instantly without the need to log into a web site or download an app, and they can automatically be sent to government agencies to meet reporting and contract tracing requirements. Press release.

Rhinomed Limited has completed development of the world's first nasal swab designed specifically for children, and the company has received Human Research Ethics Committee (HREC) approval to commence a clinical trial of the Rhinoswab Junior at The Royal Children’s Hospital Melbourne. The Rhinoswab Junior has been designed to deliver all the benefits of the existing Rhinoswab but with several novel features that reduce the fear, anxiety and trauma associated with the use of existing standard of care nasal swabs. The trial, known as The Diagnosis of Respiratory Disease in Children with Rhinoswab Study (DIY Rhinoswab Study), will investigate the diagnosis of respiratory viruses in children with Rhinoswab Junior, which is designed to collect a nasal sample from children without the discomfort and distress often associated with the combined throat and deep nasal (CTDN) swabs. Press release [PDF]

Foundation Medicine has announced a partnership to integrate its comprehensive genomic profiling (CGP) and other testing services with Epic’s electronic medical record (EMR) system. Once completed, all providers who use Foundation Medicine’s instance of Epic will be able to electronically order Foundation Medicine tests within the Epic network. The integration is designed to support oncology practices, academic medical centers and other health systems by providing easy access to clinical and genomic information in one place to better enable more streamlined clinical decision making. This integration is one of many updates Foundation Medicine is making across its portfolio to help expand precision oncology through efficient and high-quality, data-driven insights. This integration will enable clinical teams to place orders for Foundation Medicine’s CGP tests, and receive and view results directly within their existing workflow in Epic’s EMR platform. The enhancement will also target to reduce data entry with the aim of accelerating delivery of actionable insights to physicians to help guide treatment planning. Press release.

Renalytix has published results from an external chronic kidney disease budget impact analysis projecting 5-year savings of $1.1 billion for a population of 100,000 patients with type 2 diabetes (T2DKD) and chronic kidney disease tested with the Renalytix KidneyIntelX testing solution. Savings were driven by more effective pharmacy management and appropriate specialist referral compared to current standard of care for patients at high risk for disease progression and kidney failure. The detailed clinical and cost analysis concluded that health systems and insurance plans would realize these significant cost savings based on slowed disease progression (52% of savings), delayed, or prevented dialysis and transplants (32% of savings), and reduced dialysis crashes (11% of savings). Given the costs associated with current standard of care, the addition of an actionable bioprognostic approach to predict kidney function decline in T2DKD patients, stages 1-3b resulted in a projected 5-year savings of $1.1 billion associated with KidneyIntelX. Press release.

Kaia Health has recently revamped its C-suite, adding Gemma Wenstrom as Chief Operations Officer, CJ Mark as Chief Revenue Officer, Manu Diwakar as Chief Financial Officer, Sanid Khilnani as Vice President of Product, and Justin Yang, M.D., as Chief Medical Officer, US Commercial. The hiring announcements follow Kaia Health’s recent $75 million Series C round ($125 million raised to date) to expand clinical capabilities, heavily invest in computer vision technology, and transform the treatment pathways for MSK in the U.S. and Europe. Website.

The Research and Innovation Center of Maccabi Healthcare Services, Israel's leading HMO, has announced the deployment of Ibex Medical Analytics’ Galen Gastric platform at Maccabi’s pathology institute, making it the first laboratory in the world to use AI for detecting cancer in the gastrointestinal (GI) tract. Galen Gastric is an integrated diagnostics and quality control solution that supports pathologists in the detection of gastric cancer, dysplasia, H. pylori and other important clinical findings. The solution is an addition to Galen Prostate and Galen Breast that have already been deployed at Maccabi Healthcare Services, as well as other labs worldwide. With this deployment, Maccabi becomes the only health system in the world to use AI for multi-tissue cancer detection on breast, prostate and gastric biopsies, supporting their pathologists with improved accuracy, quality control and efficiency. Press release.

Smart Meter, the leader in cellular-connected remote patient monitoring (RPM) devices, data, and services, has announced the availability of its iGlucose monitor for managing gestational diabetes. iGlucose provides those with gestational diabetes an easy and reliable way to test, monitor and manage their blood glucose levels, ensuring that all care providers have immediate access to testing results. Key benefits of iGlucose in gestational diabetes include immediate transmission of BG data through cellular connectivity with AutoShare, improved visibility to patient results, critical high and low readings delivered in real-time, improved patient experience through a cellular-enabled device, and more. Press release.

Dosis, a market leader in artificial intelligence-powered precision dosing, is expanding its kidney care platform with the release of its Strategic Iron Advisor (SIA). It is being introduced as the first precision dosing tool on the market for intravenous iron. SIA is a sub-module that works with Dosis’s existing anemia tool, Strategic Anemia Advisor (SAA), to personalize anemia management. SAA is widely used nationwide to personalize Erythropoiesis Stimulating Agents (ESA) dosing, and the SIA offering broadens the capabilities of Dosis’s personalized dosing platform. SIA issues dosing recommendations for IV iron, which is often dosed in tandem with ESAs to manage chronic anemia. Iron is an essential building block of red blood cells, and patients should be iron-replete for their chronic anemia to be managed as effectively and efficiently as possible. Press release.

Harvard Medical School in Boston and Clalit Research Institute in Tel Aviv are launching a joint precision medicine effort, enabled by a donation from the Berkowitz family. The gift—the amount of which remains undisclosed at the donors’ request—will establish The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute. The program will have two arms: The Ivan and Francesca Berkowitz Family Living Laboratory at HMS and The Ivan and Francesca Berkowitz Family Precision Medicine Clinic at Clalit. The two arms will work together to conduct joint research. The Clalit arm also will feature a clinical component that, in addition to research, will provide diagnosis and care for patients with rare, undiagnosed, and hard-to-treat conditions. The research arm of the initiative will focus on generating insights from data and translating them into frontline clinical interventions. Under its educational arm, it will train the next generation of biomedical informaticians and computational biologists. The work will be led jointly by Isaac Kohane, chair of the Department of Biomedical Informatics in the Blavatnik Institute at HMS, and Ran Balicer, founding director of the Clalit Research Institute and chief innovation officer of Clalit Health Services. Press release.

Boston Healthcare is now a part of Veranex, a new global solutions provider for MedTech and Life Sciences innovators, bringing together four complementary solution providers: Ximedica, Quartesian, Experien Group, and Boston Healthcare Associates. The combined company brings deep experience in the areas of devices, in vitro diagnostics, precision medicine, digital health, and combination products/drug delivery among other technology areas. Disease areas of focus include cardiovascular, orthopedic, women’s health, wound care, ophthalmology, neurology, oncology, and gastrointestinal among others. Veranex is the first concept-to-commercialization global service provider built for medical technology innovators. The Veranex platform is designed to provide the global medical technology industry with comprehensive, integrated, and technology-enabled product development and commercialization solutions. Press release.

New results from the BabySeq Project, published in JAMA Pediatrics, showed no negative impact on families during the infant’s first year of life as a result of genome sequencing, even if monogenic disease risk or carrier status findings were returned to families. The study focused on the psychosocial effects of DNA testing by looking at the impact on the parent-child relationship, parent psychological distress and the parents’ relationship with each other. Parents completed surveys measuring those domains for about a year and a half after birth. Although minor differences between the study arm and the control arm appeared at different points, the results did not show meaningful differences in family impact over time. Researchers also found lower self- and partner-blame in the study arm compared to the control, possibly because sequencing information provided some degree of peace of mind. The researchers point out that their study consists of volunteer participants mostly of European descent and from affluent, educated families. This volunteer group may be more open to receiving genetic information. Next, the BabySeq Project team will seek to expand their study to a larger and more diverse population. The researchers also want to follow families for a longer period of time to capture long-term impacts. DOI:10.1001/jamapediatrics.2021.2829

Optellum has entered a strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson. Through the collaboration, Optellum will apply its AI-powered clinical decision support platform with the goal of increasing lung cancer survival rates through early intervention and prevention. At the core of the collaboration is Optellum's commercial software, Virtual Nodule Clinic, including an AI-powered digital biomarker based on neural networks and imaging analytics. It identifies and tracks at-risk patients and assigns a Lung Cancer Prediction score to lung nodules; small lesions, frequently detected in chest Computed Tomography (CT) scans, that may or may not be cancerous. The Optellum AI will be used to drive accurate early diagnosis and optimal treatment decisions with the aim of treating patients earlier, potentially at a pre-cancerous stage, increasing survival rates. Press release.

HiberCell has acquired Genuity Science, a life science technology company that provides world-leading genomics and multi-omic analytics bolstered by an advanced artificial intelligence (AI) and machine learning (ML) platform to illuminate the underlying cause of cancer and other diseases. The combined company brings together powerful tools that will enhance the company’s probability of clinical success through an in-depth analysis of clinical samples, a validation of pharmacodynamic biomarkers, and a deeper understanding of the responsive phenotype in patients. The combined company will also leverage the multi-omic AI/ML capabilities to exhaustively compare primary tumor biology with paired metastatic lesions to better identify the targets and mechanisms that drive metastatic disease. The stock acquisition of the Genuity Science business provides HiberCell with approximately $100 million in cash, as well as the existing partnership agreements with Ionis and AbbVie. It is expected that future earnouts of these partnerships will support HiberCell’s growth as a clinical stage biotechnology company. Press release.

Global Kinetics has entered the Remote Physiologic Monitoring (RPM) space in the U.S. market with its unique system for monitoring Parkinson’s disease (PD), the Personal KinetiGraph (PKG). The PKG system is an FDA 510(k) cleared system that features a wearable biosensor for patients to use in their home environment which collects movement data over a continuous period of time and transmits data via a cellular connection. An easy to review report is produced for the clinician to enable more personalized treatment and management decisions ultimately leading to a higher quality of life for persons living with PD. Global Kinetics provides device fulfillment directly to the patient’s home and delivers comprehensive annotated reports via a clinic-facing portal. Patients can be monitored in their own home while going about normal activities of daily living; clinic staff can review monitoring progress including effects of medication changes and adjustments to advanced therapy settings on an ongoing basis to fulfill the RPM reimbursement coding guidelines. Press release.

The U.S. Food and Drug Administration (FDA) has extended the Emergency Use Authorization for the Spectrum Solutions SDNA-1000 Saliva Collection Device to include the unsupervised self-collection of saliva for COVID-19 testing. With infection rates in the United States and around the world climbing back to serious levels from the increase in viral variants, this additional FDA authorization comes at a critical time as focus shifts back to the more reliable and 99.98% accurate PCR testing for symptomatic cases. Based on the totality of scientific evidence the FDA authorization has validated the device’s effectiveness in diagnosing COVID-19 by serving as a successful, noninvasive means to collect, neutralize, stabilize, and transport testing samples post-collection at ambient temperatures for over 10 days with no degradation in sample efficacy. Additionally, the FDA states there is no adequate, approved, or available alternative to the emergency use of this product. Press release.

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Thermo Fisher Scientific’s TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0, both highly accurate assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19. This built-in redundancy helps ensure accuracy of results in situations where gene expression in the virus vary as new mutations emerge. The TaqPath COVID-19 Fast PCR Combo Kit 2.0 assesses raw saliva and uses a simple workflow from sample collection direct to PCR to help preserve supplies. Results are returned in about two hours to enable broad, high-frequency testing. Press release.

Thermo Fisher Scientific has updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to detect the Delta and Lambda strains. First launched in March 2021, the research panel features a customizable menu of verified real-time PCR assays for identification of SARS-CoV-2 mutations. The panel enables laboratories to track known mutations by selecting from a menu of over 50 assays designed to screen for different variants. The TaqMan SARS-CoV-2 Mutation Panel is highly scalable, allowing up to hundreds of samples to be run to identify one or multiple mutations so labs can scale their surveillance operations based on testing need. The TaqMan SARS-CoV-2 Mutation Panel provides results in about an hour and is based on gold standard TaqMan SNP genotyping assay technology, which helps detect and distinguish mutations efficiently. The panel can be used with real-time PCR instruments and technology widely used in labs globally. Press Release.

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