May 27, 2020 | May featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including FNIH, Foundation Medicine, Certara, and more.
The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium program Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) has received acceptance from the U.S. Food and Drug Administration (FDA) for its Letter of Intent (LOI). NIMBLE seeks to qualify biomarkers to easily diagnose clinically significant non-alcoholic steatohepatitis (NASH). The FDA’s acceptance of the LOI submitted by the NIMBLE team signals the regulatory agency’s support of the project’s proposed path forward and its invitation to continue the process of qualifying biomarkers. An estimated 16.5 million people in the United States are living with NASH, a disease associated with obesity and diabetes and characterized by buildup of fatty tissue in the liver. NASH does not present any symptoms until it progresses to later stages, at which point the liver may already have incurred serious damage, including cirrhosis, potentially requiring a liver transplant to prevent cancer or death. Currently, the only way to definitively diagnose a patient with NASH is through an extremely invasive and painful liver biopsy. Recent FDA guidance on this growing problem—soon to be the leading cause of liver transplant in the country—recommends the qualification of non-invasive biomarkers to replace liver biopsy for diagnosis. The FDA’s acceptance of the NIMBLE team’s LOI is a major milestone for the project, which ultimately aims to enable simpler diagnosis and better treatment for people with this silent and pervasive liver disease. Press release
Foundation Medicine announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for LYNPARZA, which was also approved in the U.S. for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutatedmetastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. FoundationOne CDx is the only FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims. “This therapy and companion diagnostic approval underscores the value of comprehensive genomic profiling in advanced cancer patients as it validates our ability to identify alterations in the 14 HRR pathway genes within FoundationOne CDx’s 324 gene panel that indicate a patient may be eligible for treatment with Lynparza, a process not possible through single gene or hot spot testing,” Brian Alexander, chief medical officer at Foundation Medicine, said in a press release. “This is an important advancement for patients with HRR-mutated metastatic castration-resistant prostate cancer, as there have previously been limited treatment options available for this specific condition.” Press release
Certara announced the launch of version 19 of its Simcyp Population-based Simulator. Version 19 introduces new features to support safer and more efficient clinical studies, including models for testing drugs on pregnant women, enhanced drug formulation, and assessment of topical and transdermal drug products. The Simcyp Simulator streamlines drug development through the modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) in virtual patient populations. The simulator is a physiologically-based pharmacokinetic (PBPK) platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating and advancing new drug formulations, and predicting drug-drug interactions and PK outcomes in numerous virtual clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function. As the leading PBPK platform, the Simcyp Simulator is also currently being used to conduct virtual studies and predict exposure of candidate therapeutics for COVID-19. Press release
Smart Meter announced the launch of its iGlucose LTE Cat-M Cellular Connected Diabetes Blood Glucose Monitor and Remote Patient Monitoring System. The new iGlucose solution utilizes LTE Cat-M1 technology, the industry’s newest and broadest cellular connectivity available, to provide patients with seamless connectivity to their physicians for remote patient monitoring (RPM). Utilizing the iGlucose platform, patients simply test their blood glucose (BG) and the data is immediately transmitted via AT&T’s cellular network to their physician’s office or designated health care provider. The real-time data and ability to communicate with patients provides clinicians with an active feedback loop (text/email), enabling better, up-to-date recommendations, that can help to improve patient outcomes between visits. “In these times, it’s more important than ever to help people living with diabetes better manage themselves,” said Brahim Zabeli, CEO of Smart Meter, in a press release. “The iGlucose Cat-M innovation is a big step in assisting clinicians in doing so. Healthcare professionals will receive their patients’ blood glucose readings in real-time and are in a good position to intervene where necessary.” The iGlucose platform also allows test results to be shared with a Care Circle that can include any number of select healthcare team members and loved ones. The platform is approved for patient reimbursement through Medicare making it an affordable, easy to use system for people with diabetes. Press release
Advanced Biological Laboratories (ABL) announced the CE-IVD marking of its DeepChek-HIV Assays is now available for in-vitro diagnostics. Intended to be used on HIV-1 Group M viruses from patients diagnosed with HIV infection, the assays deliver standardized, open and flexible solution suited to clinical settings performing sequencing through Capillary Electrophoresis and Next Generation Sequencing (NGS) systems. The DeepChek-HIV CE IVD Assays are covering respectively the Protease / Reverse Transcriptase and the Integrase regions of the virus and are intended to be used from input RNA extracted from plasma, serum or whole blood samples. Both assays are highly sensitive and have been validated to process clinical samples as low as 1,000 copies/mL with outstanding performances (100% agreement of analytical reproducibility and repeatability, 100% clinical reproducibility, 99% clinical sensitivity) in all three regions. Open and flexible, the DeepChek-HIV CE IVD Assays is a unique and versatile system that can be used under a large variety of laboratory throughput configurations. “Obtaining CE IVD marking for our DeepChek-HIV assays will allow virology labs to access a unique and innovative technology, for HIV genotyping diagnostics. ABL will keep standardizing its entire portfolio of applications in virology and microbiology following European and International guidelines to improve the management of patients suffering from chronic diseases on a worldwide basis,” Chalom Sayada, CEO of ABL, said in an official statement. Press release
Erisyon announced that it is the recipient of a $188,720 grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Erisyon will use the funds to deploy the power of single molecule protein sequencing for the detection and validation of biomarkers that have the potential for early detection of the disease. Members of the Erisyon team have been at the forefront of proteomics research. The discoveries they have sparked have enabled researchers to predict functions for proteins, providing greater insight into the role proteins play in diseases. With this grant, the Erisyon team will test new methods that could provide clinicians with diagnostic tools for early identification of Parkinson’s disease. “Our single molecule assay will help untangle the mysteries of using alpha-synuclein as a potential diagnostic biomarker,” said Talli Somekh, CEO of Erisyon, in an official statement. “This technology can help to identify the smaller aggregate proteins that cause Parkinson’s before they form large, insoluble particles in the brain. With the support of The Michael J. Fox Foundation, our study aims to quantify very accurately the biomarker for Parkinson’s at a much earlier stage of the disease.” Press release
Transforming how common health conditions are diagnosed using point-of-care and wearable bio diagnostic devices is the goal of a new $2.2 million University of South Australia (UniSA) project. UniSA biomedical engineer Professor Benjamin Thierry aims to develop a range of solid-state sensing and wearable technologies capable of diagnosing conditions including preeclampsia, epilepsy, fetal arrhythmias and heart attacks. Thierry hopes these technologies will help address the significant health outcome disparities, which sees people living in rural and remote areas experience higher levels of disease and reduced access to health services, compared with their metropolitan counterparts. “There is a huge opportunity for us to create wearable devices capable of better diagnosing and monitoring medical conditions, particularly in rural and remote settings where patients often do not have access to the testing and specialist care that is available in cities,” Thierry said in an official statement. “Some of the technologies I hope to develop include wearable devices able to continuously and accurately monitor the ECG, which could in turn predict epileptic seizures or detect preeclampsia and other related pregnancy complications. These wearables use a cutting-edge solid-state sensing technology called Field Effect Transistors, which can measure bioelectric signals with extreme sensitivity when implemented at the nanoscale.” In addition, Thierry will develop conformal devices based on Magnetic Tunneling Junction sensors to record and map magnetic fields produced by electrical activity in the heart. He hopes this will enable more accurate non-invasive monitoring of fetal cardiac activity and rapid and point-of-care diagnosis of acute coronary syndrome, including heart attacks. “Central to this project is developing innovative and affordable devices that can be used directly by patients under the supervision of primary healthcare providers, without the need for invasive or lengthy testing or specialist care,” Thierry added. Press release
University of South Australia (UniSA) was also awarded more than $2 million under the National Health and Medical Research Council (NHMRC) 2021 Investigator Grants. Led by international expert in biomedical and advanced materials, UniSA's Prof Krasi Vasilev, the $2,738,220 NHMRC grant will help continue his vital work in anti-bacterial technologies for a range of medical devices, and build on his established successes in diagnostics and prognostics of diseases. The NHMRC funds will also further Prof Vasilev's ground-breaking work in cancer diagnostics and prognostics, where urine tests are providing non-invasive, cost-effective techniques to diagnose bladder cancer. Press release
sphingotec and 4TEEN4 Pharmaceuticals announced the publication of new data showing that high blood levels of Dipeptidyl Peptidase 3 (DPP3) are indicating upcoming multiple organ failure and mortality risk in burn patients. DPP3 is a proprietary biomarker of 4TEEN4 for hemodynamic instability and cardiac depression. sphingotec has in-licensed global rights to develop and commercialize in vitro diagnostic (IVD) tests for the DPP3 biomarker from 4TEEN4 and made it available on its proprietary Nexus IB10 point-of-care platform. The results from the recent study provide evidence that DPP3 blood concentrations in severely ill burn patients are indicating fatal outcomes. The data also shows that high DPP3 concentration in the blood is linked to circulatory failure, cardiac depression, and acute kidney injury. Decreasing DPP3 levels in the blood, on the other hand, indicate a substantially reduced risk of mortality. “The new data adds to the growing body of evidence that places the cardiac depressant factor DPP3 in strong connection with short-term organ failure and high mortality in critical care settings. We have already started a collaboration with the critical care community to provide our fully automated DPP3 point-of-care test to support the management of acute care patients,” said Andreas Bergmann, CEO and founder of sphingotec, in a press release. The IVD test for DPP3 is commercialized under the brand name IB10 sphingotest DPP3 and is designed and validated for use in conjunction with sphingotec's fully automated Nexus IB10 whole blood point-of-care platform, delivering results within 20 minutes. This new test complements a wide-range of assays for acute care settings that are already available on this widely used point-of-care platform that can be flexibly deployed in laboratory as well as near-patient settings such as emergency departments and intensive care units. Press release
Genetesis announced it has closed significant strategic investments from TDK Ventures and an undisclosed Fortune 500 global, healthcare company, completing a $9.2M Series B financing. The round included participation by return investors CincyTech, Ohio Innovation Fund, and Mark Cuban. Genetesis developed the CardioFlux Magnetocardiograph (MCG) to revolutionize the triage of chest pain, which causes eight million visits to hospital emergency departments annually. CardioFlux enables physicians to measure and record the magnetic fields of the heart in just a few minutes, with the potential of significantly lowering length of stay in the ER. It is done without the use of ionizing radiation, exercise or the need for specialized room modifications. “Magnetocardiography has been around for over four decades. But we felt that Genetesis has made the right technical plus business model innovations to solve the chest pain triage problem, thus freeing up valuable hospital resources and impacting patients' lives. Precision health is a highly strategic area for TDK and it is refreshing to see a magnetic sensing technology, where TDK has pioneering expertise, being applied to a sustainable goal of improving global wellness,” Anil Achyuta, Investment Director at TDK Ventures, said in an official statement. Genetesis has also added Sajid Malhotra to its Board of Directors. Malhotra brings extensive experience in senior executive positions in publicly traded companies. He has served as Chief Financial Officer (CFO) of Limelight Networks since April 2016, where he also leads the corporate development and investor relations, facilities, and procurement functions in the company. Press release