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CLIA-Certified Personalized Blood Test for Multiple Myeloma, Wearable Sensor Detects Blood Biomarker for Heart Attacks, More

March 30, 2023 | Personalized treatment for high-risk patients with asthma and chronic obstructive pulmonary disease to improve their health outcomes; state-of-the-art AI algorithms provide a real-time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients; bioelectronic sensors that will aid in cheap, accurate, and rapid pathogen detection; and more. 

A research team from the University of Texas at Austin presented their infectious disease sensor at this month's American Chemical Society spring meeting. The group constructed the COVID-19 and flu sensor using graphene, a single layer of carbon atoms arranged in a hexagonal lattice pattern. To build the infection sensor, the researchers linked antibodies against SARS-CoV-2—the virus that causes COVID-19—and against the flu virus to graphene. When a sample from an infected person is placed on the sensor, these antibodies bind to their target proteins, prompting a change in the electrical current. Their results indicated that the sensor could detect the presence of disease in extremely low quantities. This sensitivity suggested the sensor could detect more sparse viral particles in the breath. Press release

UC Davis Health and Propeller Health announced a new collaboration to offer personalized treatment for high-risk patients with asthma and chronic obstructive pulmonary disease to improve their health outcomes. As part of the collaboration, UC Davis Health will provide the Propeller program—including sensors, a mobile app, a web portal, and personalized support—to eligible patients, eventually expanding to patients in other UC locations and affiliates. The sensors attach to a patient’s inhaler to capture unique signals that record events, such as medication usage or respiration. This data will be transmitted directly to UC Davis Health’s Epic electronic health record system to support enrollment and remote patient monitoring via single sign-on. Press release

Brainomix announced that its Brainomix 360 e-ASPECTS tool for stroke had received U.S. Food and Drug Administration clearance, enabling the Oxford-based company to deploy its cutting-edge stroke AI imaging platform to US stroke centers. The Brainomix 360 stroke platform is a collection of tools that use state-of-the-art AI algorithms to support doctors by providing a real-time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients. Powered by explainable AI, the Brainomix 360 e-ASPECTS tool automatically assesses non-contrast CT scans to generate an ASPECTS score. ASPECTS is used to measure the extent of early ischemic changes and as a key selection criterion for endovascular treatment in all major stroke guidelines. Press release

FutureNeuro announced two collaborative research projects with IQVIA and Novartis Ireland to advance the use of data in healthcare research and clinical care delivery. The DataScape project, in collaboration with IQVIA, explores key stakeholders' attitudes, expectations, and concerns on using health data for healthcare improvement and research. The Learning Health System in a Digital hospital project focuses on developing a prototype Learning Health System that will integrate patient data from clinical dashboards with research analytics. Through industry partnerships, FutureNeuro aims to create new technologies and solutions for treating, diagnosing, and monitoring chronic and rare neurological diseases. Press release

NeoGenomics announced the commercial availability of the RaDaR assay, a liquid biopsy test for molecular/minimal residual disease (MRD). MRD is the trace amounts of circulating tumor DNA that remain after surgery or other cancer treatment. Results from the RaDaR test can help clinicians determine whether their cancer patients have residual disease after curative intent therapy or surgery. The RaDaR assay has been available for clinical research studies and pharmaceutical collaborations over the last year. It is now open to U.S. clinicians for breast, colorectal, lung, and head and neck cancer patients. Press release

Rapid Novor announced its diagnostic laboratory obtained the Clinical Laboratory Improvement Amendments (CLIA) certification for its EasyM assay as a laboratory-developed test. The EasyM assay measures M-protein levels—a well-known biomarker for multiple myeloma—using a personalized blood test and Rapid Novor’s proprietary MS-based protein sequencing technology. The CLIA certification of Rapid Novor’s Diagnostic Laboratory means that patients in the U.S. diagnosed with multiple myeloma can now access EasyM as a clinical testing option for enhanced disease monitoring. Press release

Visby Medical announced that it received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration for its second-generation point of care (POC) test. The Visby Medical Sexual Health Test is a fast, polymerase chain reaction (PCR) diagnostic test for detecting sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women. Visby Medical created the first and only “instrument-free” platform that offers true PCR technology in the palm of your hand. The CLIA-waived, Sexual Health POC test provides accurate results in under 30 minutes, enabling clinicians to test, talk, and accurately treat with confidence in a single patient visit. Last year, the Centers for Disease Control and Prevention reported that STIs had reached an all-time high for the sixth consecutive year, with a nearly 30% increase in gonorrhea and chlamydia between 2015 and 2019. Press release

King Abdullah University of Science and Technology (KAUST), Saudi Arabia, bioengineers are researching the design of sensors that use biological components to recognize specific disease biomarkers in a single patient sample. They are collaborating closely with a team from King Faisal Specialist Hospital and Research Centre team to help develop and trial bioelectronic sensors that will aid in cheap, accurate, and rapid pathogen detection. The sensor developed by the KAUST team detects pathogens from saliva samples provided by their collaborators at King Faisal Specialist Hospital and Research Centre. The teams hope their technology will advance rapidly to provide early, accurate detection of infectious and noninfectious diseases. Press release

Neogap and Simsen Diagnostics initiated a collaboration to improve personalized cancer diagnostics by examining circulating tumor DNA in the blood of patients participating in Neogap's phase I/II clinical trial. The goal is to develop more precise and effective diagnostic tools for cancer. Neogap's personalized Trained Tumour Lymphocytes cell therapy is an immunotherapy designed to treat solid tumors by training the immune system to recognize and attack cancer cells using specific altered proteins called neoantigens. Neogap has commissioned Simsen Diagnostics to measure the circulating tumor DNA levels in the blood of patients participating in Neogap's upcoming immunotherapy trial. These measurements will be used to evaluate the therapy's effect by comparing the development and survival of tumor cells over time. Neogap's proprietary PIOR software will analyze the data collected during the trial. Press release

NeoGenomics announced the expansion of their next-generation sequencing portfolio of innovative products with the commercial availability of multiple tests, including Neo Comprehensive - Solid Tumor, a comprehensive genomic profile (CGP) for solid tumor cancers and Neo Comprehensive - Myeloid Disorders, a CGP for myeloid neoplasms. In parallel with the two product launches, NeoGenomics is also introducing two software resources to complement its testing menu: NeoAccess, a test requisitioning tool that includes clinical decision support, the up-front patient benefits check, and prior authorization assistance abilities, and NeoSeek, a platform that allows clinicians the ability to mine their previous testing data to identify their patients who may be biomarker eligible for a new therapy or clinical trial. Press release

Insilico Medicine has integrated advanced AI chat functionality based on recent advances in large language models into its PandaOmics platform. The new feature, ChatPandaGPT, enables researchers to have natural language conversations with the platform and efficiently navigate and analyze large datasets. PandaOmics is an AI-driven target discovery platform developed by Insilico Medicine that applies deep learning models to identify therapeutic targets associated with a given disease through a combination of omics data analysis. PandaOmics’ knowledge graphs offer insights into the molecular mechanisms of diseases and the biological activities of genes and compounds in the context of a disease. It also reveals the most promising drug targets and biomarkers. The integration between ChatPandaGPT and PandaOmics is available now, allowing researchers to begin navigating and analyzing large datasets and making important discoveries more efficiently. Press release

Agilent Technologies announced a highly anticipated end-to-end solution for digital pathology that brings together best-in-class products from Agilent, Visiopharm, Proscia, and Hamamatsu Photonics K.K. With the addition of Hamamatsu Photonics K.K.’s NanoZoomer Slide scanner systems—which converts glass slides into high-resolution digital data by high-speed scanning—Agilent completes its offering of an open and agnostic digital pathology workflow designed to accelerate breakthroughs in precision medicine. This scalable digital pathology workflow features scanners, an image management system, and digital pathology applications compatible with Agilent pathology solutions and other technology and laboratory information systems. The technology combination of Agilent, Visiopharm, Proscia, and Hamamatsu strengthens the development of an open and agnostic end-to-end digital pathology solution with the vision of accelerating breakthroughs in precision medicine. Press release one and two

Researchers from France, the Tehran University of Medical Sciences in Iran, and the United States identified mutations across ten genes that could predict the most common type of bladder cancer up to 12 years before diagnosis. Their study was based on the UroAmp test, a general urine test identifying mutations in 60 genes, developed by the Oregon Health Science University spin-out company Convergent Genomics. The results were consistent in individuals with known risk factors for bladder cancer undergoing cystoscopy and those with no evidence of disease. Press release

COTA announced a new partnership with Genomic Testing Cooperative (GTC). The two companies are integrating COTA’s deep clinical oncology real-world data with GTC’s comprehensive genomics testing data. This strategic and oncology-specific partnership, grounded in deep, comprehensive clinical data, will support more detailed, personalized cancer research, particularly across early discovery and translational epidemiology functions. GTC tissue-based, and liquid biopsy testing uniquely leverages DNA and RNA sequencing for both solid and hematologic cancers to generate information on mutations, chromosomal structural abnormalities, biomarkers that can replace or complement immunohistochemistry, flow cytometry, and standard tumor markers. This comprehensive profiling is captured before treatment and frequently after relapse so a fuller picture of treatment impact on a specific patient population can be understood. Press release

Scientists from Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey,  presented an experimental wrist-worn device at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology found to predict troponin-I and obstructed arteries with 90% accuracy in five minutes. The study is the first multicenter trial to assess a wearable troponin sensor in a real-world clinical context. Troponin-I is a protein that enters the bloodstream when the heart muscle becomes damaged. According to researchers, the new wearable sensor could help augment that diagnostic process by assessing the likelihood of a patient having a heart attack before lab results are available. The wrist-worn sensor uses infrared light to detect the presence of troponin-I in the blood through the skin. The device sends signals via Bluetooth to a cloud-based system, where a machine learning algorithm relates the information to training data to predict the wearer’s troponin level. Press release

Penn State Health scientists presented a study at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology featuring a stick-on sensor that alerts clinicians about fluid buildup in the lungs. The scientists reported that people with heart failure were 38% less likely to be readmitted to the hospital for heart failure complications within 90 days if they wore the sensor. By monitoring a patient’s condition remotely, the device encourages clinicians to adjust medications earlier and prevent complications from escalating. In addition to its thoracic fluid measurements, researchers plan to study how additional data collected by the µCor device, such as heart rate and breathing rate, could offer a more comprehensive picture of a patient’s condition. Press release

Personalis announced that its Board of Directors had appointed Christopher Hall as CEO and a member of the Board, effective immediately, in addition to his role as President. Hall will lead the Company’s efforts to drive a new paradigm for active cancer management to guide care from biopsy throughout the patient's life. The Board also promoted Aaron Tachibana to the extended leadership position of Chief Operating Officer, effectively immediately, in addition to his role as Chief Financial Officer. In addition, Dr. Richard Chen has been promoted to Executive Vice President, R&D, effective immediately, in addition to his role as Chief Medical Officer. Press release

Lucem Health announced the availability of its new early disease detection solution, Lucem Health Reveal, which leverages existing electronic health record data to identify patients at a higher risk of severe or chronic disease. Part of the Mayo Clinic Platform portfolio, Lucem Health Reveal solutions surface previously undiscovered insights in readily available clinical data and bring proactive AI insights that may reduce delays in diagnosis and treatment, most notably in diabetes or lower GI disorders. Reveal solutions leverage the promise of AI for early disease detection and respect clinicians’ limited capacity for added clicks, new workloads, or administrative burden. Press release

BGI Genomics' multiplex bacterial resistance genes detection kit, multiplex nucleic acid kit for respiratory pathogens, and central nervous system (CNS) pathogen identification test kit based on PM Easy Lab—a fully automated medical PCR analysis system—have received market authorization from the Thailand Food and Drug Administration and the Saudi Food & Drug Authority. These three products facilitate clinical diagnosis and promote the informed use of antibiotics, especially for patients with CNS or respiratory tract infections. This multiplex bacterial resistance gene test kit can simultaneously detect four common drug-resistant bacteria through fluorescent PCR. The multiplex nucleic acid test kit enables the simultaneous detection of 14 common respiratory tract infection pathogens. The CNS pathogen identification kit detects the 12 most common pathogens of CNS infections. The PM Easy Lab pathogenic nucleic acid rapid test solution offers comprehensive coverage of a wide range of infectious agents, thereby addressing clinical pain points in a one-stop and cost-effective manner. Press release

Eko announced the launch of the SENSORA Cardiac Disease Detection Platform. SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system. SENSORA is a cardiovascular disease detection platform that combines the latest advancements in applied machine learning with one of the most ubiquitous medical devices in the world: the stethoscope. Care Pathway Analytics is designed to assist with critical decision-making by identifying care gaps that can be transformed into improved operational efficiencies, including reduced delays in delivery of care, length of stay, and readmission rates, all while improving patient and physician satisfaction. Eko is committed to impacting patients and clinicians by creating advanced solutions that meet their needs, enable early detection of heart and lung diseases, and save lives. Press release

Brainomix announced its involvement in a new study sponsored by the University of Liverpool focused on post-stroke atrial fibrillation (AF). Sites with existing clinical deployments of Brainomix’s e-Stroke platform will utilize the AI system to collect real-time imaging data and securely transfer it to the central investigators. The Liverpool-Huawei Stroke Study aims to determine the clinical effectiveness, cost-effectiveness, and acceptability of Huawei Smartwear to detect AF in patients following an acute ischemic stroke. Ultimately, the aim is to improve the detection of AF to initiate earlier treatment and reduce the risk of recurrent stroke in populations post-stroke. Its detection is critical to begin appropriate monitoring and treatment to reduce the risk of recurrent stroke. Press release

PreciseDx announced that the New York State Department of Health (NYSDOH) approved the PDxBr, a lab-developed test (LDT) designed to enrich breast cancer grading and improve risk categorization. PreciseDx can begin commercially testing patient samples in New York through its CLIA-certified laboratory with this approval. The Clinical Laboratory Evaluation Program Assay Validation Review is considered one of the most important and rigorous levels of validation for LDTs. Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance and reproducibility. Press release