December 22, 2021 | Diagnostics partnerships on scalp-sensing electrodes, AI-powered pathology, and devices in China. Plus new products from Leica Microsystems, Foundation Medicine, PerkinElmer, more.
AI startup Owkin and Amgen have announced the results of a three-year project to use artificial intelligence to more accurately predict cardiovascular risk. This study demonstrates the ability of AI to improve the way that clinicians predict patients' risk of suffering major cardiovascular events, such as strokes and myocardial infarctions. Using data from 13,756 patients who were part of FOURIER, a large Amgen clinical trial, Owkin trained a machine-learning algorithm to predict those at higher risk of cardiovascular events. Published in the upcoming December issue of the European Heart Journal - Digital Health, the results show that machine learning is more efficient and effective than the statistical models routinely used by clinicians. Press release.
Achiko AG, a global healthtech company which has developed technologies that deliver rapid, affordable diagnostic testing for Covid-19, associated variants, and a range of other pathogenic diseases and therapeutic indications, is pleased to announce that the Company’s common shares have been approved to trade on the US-based OTCQB Market under the ticker symbol ACHKF. The Company’s shares will continue to trade on the SIX Swiss Stock Exchange under the symbol ACHI, ISIN CH0522213468. Achiko has created a unique health tech ecosystem with its affordable, non-invasive Covid-19 rapid test AptameX integrated with a digital passport solution that provides assurance services to communities, empowering them to enable people to integrate safely and confidently back into their daily lives. AptameX is a highly sensitive diagnostic that fills the gap in the Covid-19 testing market between less accurate rapid tests and expensive PCR testing with longer turnaround for results. Press release.
AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, has announced that KardiaMobile 6L, the most clinically-validated six-lead personal ECG device, is now available via KardiaPro on Epic's App Orchard Marketplace for hospitals, health systems and providers. The integration will enable even more healthcare providers around the world to seamlessly prescribe and deliver the physician-preferred remote ECG monitoring solution to patients who have an electronic record at a hospital organization that uses Epic. Press release.
SAS and PERSOWN, formerly known as Blink Science, are partnering on diagnostics. PERSOWN is developing a novel point-of-care diagnostic platform that plans to provide instant test results using ultra low-cost disposable test strips and a handheld reader, fully integrated with a robust suite of electronic health records applications. This platform will present a cost-effective option for testing in parts of the globe where access to sophisticated medical diagnostics is scarce, potentially creating billions of integrated data points across various disease states and among previously undiagnosed populations. With powerful SAS artificial intelligence, visual analytic and data management software, PERSOWN will be able to effectively mine diagnostic data to uncover infection trends and visualize disease hot spots to better monitor and predict outbreaks. These early insights will help governments and health organizations implement practices that reduce disease spread, mitigate impact and create early interventions. Press release.
Brain signal recording with the Wyss Center for Bio and Neuroengineering’s subscalp Epios sensing electrodes (leads) is being carried out for the first time in patients at the University Hospital Bern, Inselspital. The clinical trial is the first step towards the validation of Epios, a minimally invasive, long-term brain monitoring system intended for people with drug resistant epilepsy. The trial will assess the feasibility, safety and recording ability of the electrodes and will test the tools developed to insert the leads based on required locations and patient specific anatomy. Press release.
Akoya Biosciences, The Spatial Biology Company, and PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, have announced a collaboration to advance the discovery and validation of novel predictive biomarkers for immunotherapies. The partners will leverage their industry leading capabilities in spatial biology and deep data mining using Phenoptics, Akoya’s high throughput spatial phenotyping platform, and PathAI’s artificial intelligence tools and algorithms to enhance their shared biopharmaceutical partners’ ability to identify patients most likely to respond to drugs in clinical trials. Akoya will work with PathAI to create a seamless interface between the Advanced Biopharma Solutions (ABS) service offerings and PathAI’s analytical capabilities to provide a powerful and complete solution for biopharma partners. This partnership and ABS’ recent CLIA certification represent significant milestones in advancing Akoya’s ability to serve the growing demand for spatial biomarkers in clinical trials. Press release.
Clearsky Medical Diagnostics and Shanghai Accurature Diagnostics have entered into a strategic cooperation agreement related to commercializing PD-Monitor in China. PD-Monitor is a medical device using ClearSky’s proprietary AI technology to assist the diagnosis and measurements of neurodegenerative diseases, such as Parkinson’s. As an active national player specialized in providing diagnostic and care solutions for mental health and neurologic conditions, Shanghai Accurature Diagnostics will be responsible for incubating and commercializing PD-Monitor in China. Following the agreement, ClearSky will continue to drive commercialization in other parts of the world while focusing on continuous product development. Press release.
Immunexpress has announced that SeptiCyte RAPID has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cleared test is an aid in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis. Immunexpress has been a leader in host response sepsis diagnostics, and this second FDA clearance translates its biomarker technology to the sample-to-answer Biocartis Idylla near-patient testing platform. SeptiCyte RAPID contains all the reagents needed for quantification of gene expression using a reverse transcription polymerase chain reaction (PCR) to determine the relative expression levels of host response genes directly from whole blood. The process is fully automated in a user-friendly, hands-free format, and a result is obtained in one hour. Press release.
Leica Microsystems, a leading manufacturer of microscopes and scientific instruments, has released the ARveo 8, a digital visualization neurosurgery microscope with ultra-fast processing speeds. Through the use of advanced augmented reality (AR) visualization, ARveo 8 enables the entire neurosurgical team to benefit from an improved level of AR visualization by utilizing AR fluorescence imaging, IGS information, and endoscopic imaging. The ultra-fast processing capabilities of the ARveo 8 delivers visual information to users with a more natural, real-time feel to help them make informed and precise decisions during surgery. ARveo 8 helps increase efficiency in the OR, improves system accessibility for the entire team with its new graphical user interface, and provides the freedom to adopt more new technologies and AR applications as they become available. Press release.
Foundation Medicine has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. This approval makes FoundationOneCDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists. Press release.
PerkinElmer announced the research use only (RUO) launch of the NEXTFLEX Variant-Seq SARS-CoV-2 Kit v2 to accelerate the detection of SARS-CoV-2 variants. This complete next generation sequencing (NGS) solution will allow laboratories to increase sequencing throughput and make reliable variant identifications. Using positive SARS-CoV-2 samples, the NEXTFLEX Variant-Seq SARS-CoV-2 Kit v2 detects mutations associated with all SARS-CoV-2 variants, including the latest Variant of Concern (VOC) identified by the World Health Organization, Omicron (B.1.1.529). This kit offers substantial benefits to laboratories in terms of speed, scalability and cost savings by incorporating newly developed NEXTFLEX normalization beads, which reduces turnaround time by three hours on average for 96 samples (when compared to other standard library prep kits that require quantification and normalization of individual samples before pooling). Additionally, the NEXTFLEX Variant-Seq SARS-CoV-2 Kit v2 uses 1,536 Unique Dual Index (UDI) barcodes to enable the sequencing of 6,000 SARS-CoV-2 libraries in one flow cell. This provides extremely high throughput and minimizes per sample costs associated with sequencing. Press release.
PacBio and the UCLA Institute for Precision Health and David Geffen School of Medicine at UCLA have formed a research collaboration to further identify the causes of rare diseases. The study will leverage PacBio’s HiFi long-read sequencing technology for whole genome sequencing (WGS) to look at undiagnosed pediatric rare disease patients who have already been sequenced with short-read technology. Dr. Stanley Nelson, Director, California Center for Rare Diseases, and professor, pathology and laboratory medicine and human genetics, David Geffen School of Medicine at UCLA, will be pioneering the combined use of full-length isoform sequencing (Iso-Seq) and long-read WGS in an effort to investigate the effect on diagnostic yield in these unresolved cases. Press release.
LiquidLung has announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application No. 17/003,775 for claims related to the non-invasive diagnosis of lung cancer. The technology, which is centered around a comprehensive portfolio of novel RNA biomarkers, developed in concert with Liquid Biosciences, a leading bio-analytics provider and dedicated partner to LiquidLung. The technology uses various mathematical gene expression signatures that uniquely span early detection and confirmatory diagnosis of lung cancer, both pre- and post-imaging, as well as the diagnostic classification of several prevalent histological subtypes of the disease. In an independent validation study the lung cancer technology was applied to a blood-based dataset comprised of fully adjudicated in vivo patient samples consisting of patients with confirmed lung cancer and those without lung cancer, the technology achieved 97% sensitivity and 85% specificity for lung cancer detection. Press release.
Swiss medtech company Bloom Diagnostics announced European approval for its Bloom Ovarian Reserve Test, measuring AMH (Anti-Müllerian Hormone) using their Bloom System, at-home or in a professional setting. The approval means that women in Europe will be able to test for this fertility marker and receive real-time feedback at the comfort of their own homes. The single-use self-testing kit for quantitative in-vitro diagnostic examination of the Anti-Müllerian Hormone is designed for women 18 to 39 years. Pin-prick blood samples are captured in the Bloom Test strip, which is then deployed into the Bloom Lab. Cloud-based algorithms aggregate test results with other information about health status indicators alongside medical history, lifestyle, and individual symptoms. Fully encrypted feedback is delivered through a personalized report on the Bloom App after just 20 minutes. Press release.