February 27, 2019 | February featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including HudsonAlpha, SAW Dx, Entasis, and more.
Scientists at HudsonAlpha have helped identify a genetic change that is causing Alzheimer’s disease, expanding what we know about how the disease can be inherited and giving participants in the study an opportunity to join prevention trials. Researchers looked at 93 members of a family in Colombia that had a history of inherited Alzheimer’s disease. They found that 26 of them had a never-before-identified mutation on PSEN1, a heavily studied gene, known to cause Alzheimer’s. By discovering new mutations, scientists are better able to understand how the gene works as a whole. Current drug trials aim to alleviate Alzheimer’s symptoms through early treatment, and in unique families like those identified in this study, there is the opportunity to start therapy years before symptoms begin. By identifying this mutation, scientists hope to give affected individuals the chance to participate in these trials early to maximize the chance of a therapeutic benefit. PSEN1 encodes an enzyme that works almost like scissors in the production of a protein called amyloid beta. When PSEN1 is mutated, the amyloid beta proteins wind up being too long, making them stickier, so they more easily form into plaques in the brain. Preventing the formation of those plaques may help alleviate symptoms. This latest study recently appeared in Alzheimer’s and Dementia. Ken Kosik of the University of California, Santa Barbara (UCSB) led the study along with Francisco Lopera from the University of Antioquia. HudsonAlpha scientists from the Richard M. Myers Lab assisted with analysis of the data. “These large family studies give us an incredible opportunity to understand how Alzheimer’s works at a genetic level,” Kosik said in a press release. “Studying these early-onset cases—including people who are presymptomatic—give us a chance to really dig deep into what specifically is changing in the body, brain and genome to cause the degeneration. It also allows us an opportunity to try to ward off the worst of the disease.” Press release
SAW Dx announced that Innovate UK, the UK’s innovation Agency, has awarded the company a £1.5M ($2M) grant in support of the company’s low-cost sample preparation system, for use in infectious disease detection and other applications. The new non-dilutive award follows the recent successful completion of work under a £1M award from the UK Government’s Biomedical Catalyst fund, directed towards development of the company’s detection technology for infectious disease diagnostics, and paves the way for the Company to secure its next venture round to drive commercialization of its platform and first product. The Innovate UK program, which requires industry matched funding, will finance development of the Company’s integrated sample processing technology platform over the next two years. The platform is designed to enable molecular detection directly from a range of complex clinical sample types in a range of “near-patient” and research settings. SAW Dx is built on unique acoustic-flow technology developed at the University of Glasgow’s School of Engineering. Samples of patients’ blood, swabs or urine are placed on a disposable chip. The interaction between the sound waves and the chip enables the release of DNA and its amplification, potentially enabling test results in as little as 15 minutes. Press release
Entasis announced a successful End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) regarding ETX2514SUL for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. A Gram-negative bacterium causing severe infections, A. baummanii is associated with high mortality, rapidly-increasing rates of antibiotic resistance, growing significance as a hospital-acquired infection, and limited treatment options. Following this meeting, Entasis remains on track to initiate its Phase 3 clinical trial for ETX2514SUL in the first quarter of 2019. Further, Entasis announced an agreement with bioMérieux pursuant to which Entasis will incorporate BIOFIRE FILMARRAY Instruments and BioFire FilmArray Pneumonia Panels into its global Phase 3 trial for ETX2514SUL for enrollment optimization. The BIOFIRE System is an FDA-cleared and CE-marked multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The BIOFIRE System requires only two minutes of hands-on time and has a total run time of approximately 45 to 75 minutes, depending on the panel. The BIOFIRE Pneumonia Panel and the BIOFIRE FILMARRAY Pneumonia Panel plus received FDA clearance and CE-Marking in November 2018. The BIOFIRE Pneumonia Panels enable fast, accurate, and comprehensive syndromic testing for lower respiratory tract infections and can identify 33 targets, including A. baumannii, direct from sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL) sample types. Press release
MaxQ AI announced that through its collaboration with Intel, it was able to triple the computational performance of its Accipio intracranial hemorrhage (ICH) and stroke detection platform, enabling clinicians to prioritize critical patients and provide faster, near real-time ICH diagnosis. MaxQ AI’s Accipio platform uses vision algorithms comprised of machine learning neural networks capable of reading all major CT OEMs’ non-contrast CT with a goal of providing speed and confidence in diagnosing suspected ICH. Accipio Ix has received both FDA clearance and CE Mark certification, and is being deployed through major OEM CT and PACS partners to the global acute healthcare space. Medical errors are the third-greatest cause of death in the US. As an example, stroke patients are misdiagnosed in emergency rooms between 9% and 30% of the time. It is projected that there will be 3.4 million stroke victims by 2030, which will cause loss or extreme hardships for patients and their families while generating $240 billion in total direct and indirect costs. MaxQ is committed to harnessing the power of AI to raise the level of acute care in hospitals with expert results that can potentially save lives, improve quality and lower healthcare costs. Based on deep-learning technologies, the Accipio lx software platform is trained to automatically analyze CT images for ICH. The acute imaging AI engine leverages deep vision and cognitive analytics to compare billions of data points to identify even rare, long-tail anomalies. The platform is capable of combining the full richness of medical imaging along with other relevant patient data. MaxQ‘s Accipio Ix reduces the time needed to detect hemorrhages, enabling physicians to prioritize patient care when time is of the utmost importance. MaxQ AI’s Accipio Ix can now achieve over 300% acceleration in the computational flow of algorithms on Intel AI, without impacting detection accuracy. Press release
CareDx announced that AlloSure is now available under a compassionate use program for lung transplant patients. AlloSure Lung is the next addition to the CareDx portfolio of transplant surveillance services, alongside AlloSure Kidney and AlloSure Heart. Lung transplant patients have the lowest survival rate of any solid organ transplant, and there are few options for rejection monitoring. AlloSure Lung directly addresses this unmet need with a noninvasive blood test. CareDx will be making AlloSure Lung available for this high need patient population through a compassionate use program while the test is undergoing further studies. Caregivers and patients are encouraged to contact CareDx for more details. “There is an incredible unmet need for blood based surveillance in this patient population,” said Peter Maag, Chief Executive Officer at CareDx, in a press release. “We have built a great body of evidence and together with recent publications, we believe it is best for patients to offer AlloSure now under compassionate use.” Press release
The Virginia Commonwealth University (VCU) College of Engineering and Fuzionaire Diagnostics (Fuzionaire Dx) have executed a research agreement establishing a collaborative program to work toward applications of Fuzionaire Dx’s proprietary radiochemistry platform. The focus of this effort will be to develop new radiopharmaceutical lead candidates and will explore Fuzionaire Dx’s platform as a unique tool for drug discovery. The versatile chemistry-driven platform, which can radiolabel molecules at record-breaking speed and ambient temperature, has the potential to generate a wide variety of novel radiopharmaceuticals enabling clinicians to better diagnose and treat diseases including cancers, viruses and neurodegenerative and cardiovascular diseases. The platform could also become a powerful new tool for drug discovery, offering valuable insights on the in vivo behavior of pharmaceutical lead compounds at an early stage. The multiyear research effort will leverage the research and development resources of Fuzionaire Dx and VCU College of Engineering, where chemistry, nuclear medicine, biology and radiology expertise and infrastructure could complement Fuzionaire Dx’s efforts to move its discoveries from bench to bedside. Press release
RenalytixAI announced the completion of a joint venture partnership agreement with AKESOgen. AKESOgen brings a state-of-the-art 14,000 square foot CLIA certified and CAP accredited laboratory facility that enables RenalytixAI to immediately scale operations to support additional business partnerships on a variable-cost basis without incurring additional fixed overhead. RENX AI Labs provides RenalytixAI with further operations outside of its recently configured New York City-based clinical laboratory operations in JLABS, a Johnson & Johnson Innovation center. The joint venture, named RENX AI Labs, significantly expands the operational capacity available to RenalytixAI. RENX AI Labs will provide services directly to health systems and pharmaceutical companies located in all regions of the United States. The joint venture enables RenalytixAI to support prospective revenue-generating contract research, clinical diagnostic and clinical trial services that are part of the Company's core business model with KidneyIntelX and other products under development. RENX AI Labs will help support the programs of pharmaceutical companies by applying AI-enabled diagnostics, beginning with KidneyIntelX, which is currently undergoing clinical validation, to improve patient characterization and enrich targeting of patients for drug clinical trials for renal disease. Better identification and characterization of enrolled patients has the potential to reduce trial cost and duration, and increases the likelihood of reaching successful outcomes. RENX AI Labs also has the capability to develop companion diagnostics under stringent quality-control processes. Press release