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uBiome, AliveCor, Ariel Precision Medicine, And More: News From September 2018

September 26, 2018 | September featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including uBiome, AliveCor, Ariel Precision Medicine, and more.

Ariel Precision Medicine announced the national launch of ArielDx, a cloud-based clinical decision support tool designed to simplify the diagnosis and treatment of pancreatic disease. ArielDx integrates a patient’s genetics, collected from Ariel’s proprietary next-generation sequencing test, PancreasDx, and interprets them in the context of each patient’s symptoms, clinical history, family history and environment to deliver insights into personalized care. Each year, more than 2 million Americans develop pancreatic diseases, including pancreatitis, diabetes, pancreatic insufficiency and pancreatic cancer. In the early stages, many pancreatic diseases may be treated successfully with preventative medicine. However, patients in the early stages of pancreatic disease often present with similar symptoms, making an accurate diagnosis and treatment plan challenging. Thus, patients are typically treated symptomatically and many continue to progress until their condition reaches an advanced stage and the damage is irreversible. “We designed ArielDx to simplify the clinical application of complex genetics, systems biology, expert insights and evidence-based medicine so clinicians can personalize treatment for each patient, in a scalable way,” said Jessica Gibson chief executive officer and co-founder of Ariel Precision Medicine, in a press release. “For the first time, with PancreasDx and the ArielDx tools, we are uncovering the biological drivers of disease within the context of a patient’s unique health journey and it is so rewarding to see our solutions already having an impact on patient’s lives.” Press release

uBiome announced the company has raised $83 million in Series C financing. OS Fund led the round, with participation from 8VC, Y Combinator, Dentsu Ventures, and additional new and existing investors. The microbiome plays a vital role in every aspect of health – it has been correlated with a wide range of conditions and can provide insights into predispositions to diseases ranging from inflammatory bowel disease to metabolic disorder to cancer. uBiome combines its patented proprietary precision sequencing with machine learning and artificial intelligence to develop wellness products, clinical tests, and therapeutic targets. uBiome’s mission is to advance the science of the microbiome and make it useful to people. The company has over 200 patent assets, including seven issued patents in the United States relating to sample collection, laboratory automation, computational approaches, and molecular techniques, as well as diagnostic signatures and therapeutic targets. It has the largest human microbiome database, with over 250,000 samples (the largest in the world by 25x), projected to grow to more than one million samples in 2019. “This is the next step in the evolution of uBiome. We started with a simple wellness product to help people understand their microbiomes, expanded to clinical laboratory testing in 2015, and are now poised for expansion,” said Jessica Richman, co-founder and CEO of uBiome, in a press release. “This financing allows us to expand our product portfolio, increase our focus on patent assets, and further raise our clinical profile, especially as we begin to focus on commercialization of drug discovery and development of our patent assets.” The company’s commercial products include SmartGut, a doctor-ordered stool test that identifies microbes in the gut for patients with chronic gut conditions such as IBD, IBS, Crohn’s Disease and ulcerative colitis; SmartJane, a doctor-ordered women’s health test that genotypes all 19 clinically relevant strains of HPV, identifies four common STDs (chlamydia, gonorrhea, syphilis, and mycoplasma genitalium), and surveys more than 20 vaginal microbes associated with bacterial vaginosis and other conditions; and Explorer, a consumer product to understand the role that food and lifestyle can play in gut wellness. Press release

Cellanyx and clinical collaborators today published the first studies demonstrating the potential of a novel, live cancer cell phenotypic test to predict adverse pathology and allow risk stratification of patients with solid tumors such as prostate and breast cancer. This first-in-class, live tumor cell phenotypic test is designed to provide actionable information on cancer aggressiveness to support shared clinical decision-making. The technology and preliminary clinical results are described today in the Advance On-line issue of Nature Biomedical Engineering. “There is an urgent need for more precise cancer risk stratification tools,” David Albala, Chief of Urology at Crouse Hospital (Syracuse, NY) and an author on the paper, said in a press release. “Current risk assessments are based on analysis of formalin-fixed tissue or genomic analysis of selected genes. These methods, such as Gleason scoring for prostate cancer, lack precision in low and intermediate risk patients, leading to missed aggressive tumors, as well as over-diagnosis and over treatment of indolent disease. The high sensitivity and specificity with the phenotypic test, both exceeding 80%, reported in these initial validation studies suggest great promise as a risk stratification tool.” He added that additional studies are needed to demonstrate the test’s utility in clinical settings alongside established methods. Albala is a member of the Cellanyx Scientific Advisory Board (SAB). The Nature Biomedical Engineering paper reports the initial results from the analytical validation of the test from a multicenter, blinded clinical study of prostate tissue samples from patients who had undergone radical prostatectomies. The authors additionally describe preliminary results from a separate proof-of-principle study in breast cancer patients undergoing surgery (mastectomy or lumpectomy). Press release

Quadrant Biosciences been awarded a $2 million Phase II Small Business Technology Transfer (STTR) grant from the National Institutes of Health (NIH) for the refinement and commercialization of an epigenetic autism spectrum disorder (“ASD”) diagnostic test. This collaborative award follows the company’s successful Phase I findings and will support the ongoing work of investigators Frank Middleton at SUNY Upstate Medical University, Steven Hicks at Penn State Hershey Medical Center, and Alexander Rajan at Quadrant Biosciences. ASD is a medical condition that affects a person’s communication abilities and social skills, and often causes repetitive patterns of behavior and a narrow range of interests. Approximately 1 in 59 American children are currently diagnosed with ASD, a 10-fold increase in prevalence over the past 40 years. "ASD can have a profound impact on families,” said Quadrant Biosciences Founder and Chief Executive Officer Richard Uhlig in a press release. “While the cause of the disorder is unknown, early treatment of the symptoms can significantly improve the lives of affected children. Unfortunately, the first step in the process - diagnosis - is often delayed. Our collaborative team has developed an epigenetic test designed to facilitate the early diagnosis of ASD, thereby accelerating access to treatment.” Press release

SenzaGen announced that the company will launch GARDair, the first in vitro test for airway allergies at ESTIV2018, the 20th International Congress on In Vitro Toxicology. Removing the need for animal testing and opening a completely new market, GARDair is based on the company’s proprietary GARD technology platform. Using genetic biomarkers, GARDair tests whether substances and chemicals that are inhaled or come into contact with the lungs are allergenic or not, with high accuracy. Respiratory allergies or respiratory sensitization, which manifests itself primarily in the form of asthma, is a growing problem. About 8-10% of the Swedish population suffer from asthma and more than 300 million people worldwide are diagnosed with asthma - a figure that is expected to increase in the next few years. There are currently no methods available for testing if chemicals can contribute to or cause allergic reactions in the respiratory tract. GARDair makes use of genetic biomarkers which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity with high accuracy. GARDair is targeted primarily at the chemical, pharmaceutical and cosmetic industries where there are a wide range of testing needs from pesticides to fragrances. GARDair will be marketed through SenzaGen's laboratory in Lund and the company's licensing laboratories, which will allow immediate availability in Europe and the United States. Press release

Genomenon announced a major enhancement to the Mastermind Genomic Search Engine: the indexing of supplemental data from scientific research papers. This latest release of Mastermind includes over 500,000 new genomic variants found in the supplemental data. Mastermind powers Precision Medicine by connecting pharmaceutical companies and clinical diagnostic labs with the research used to diagnose and treat cancer and rare diseases. Mastermind already contains the most comprehensive database of genomic literature in the world, and is used by diagnostic labs to accelerate genomic interpretation for Next Generation Sequencing (NGS) of DNA. Genomenon also licenses the Mastermind knowledgebase to pharmaceutical and life science companies to identify and prioritize genomic biomarkers for drug development and gene panel design. Researchers and clinicians can now use the Mastermind Genomic Search Engine to expand their search into the supplemental materials that are often published alongside research papers and frequently contain vast collections of genomic information. Press release

INmune Bio announced that Co-Founder and Chief Scientific Officer Mark Lowdell is co-hosting and chairing two sessions at the International Society of Cell and Gene Therapy (ISCT) European Regional Meeting. “I’m delighted to be able to speak in front of leaders and visionaries in the immunotherapy space at a conference where we can help make a difference by partnering with a shared vision to translate cellular therapy into safe and effective therapies to improve patients’ lives worldwide,” said Lowdell in a press release. “I am a tremendous supporter of ISCT, an organization that has been bringing groups together, spanning the international cell and gene therapy community. I believe the organization is the pre-eminent scientific society in the field of translational cell and gene therapy.” Lowdell’s highly touted research projects have involved clinical trials of natural killer (NK) cell immunotherapies in blood cancers, paralleling the track that INmune Bio is currently involved with. His work as the professor of Cell & Tissue Therapeutics focuses on targeting human NK cells to improve cancer immunotherapy. He is a professor and consultant scientist who has been called upon to speak at prestigious conferences across the world. Press release

AliveCor announced that the US Food and Drug Administration has given the company's KardiaK Software Platform the rarely granted designation of "Breakthrough Device." This designation means that the FDA will consider the technology on an accelerated clearance track designed specifically for medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. The KardiaK Platform screens for elevated levels of blood potassium – hyperkalemia, without requiring any blood from the patient. The technology employs a proprietary deep neural network trained to detect hyperkalemia using data from electrocardiograms (ECG) similar to those captured by AliveCor's KardiaMobile and KardiaBand devices. AliveCor aims to use the platform to enable home-based hyperkalemia detection for patients with kidney disease, as well others at risk for this life-threatening condition. "We are gratified that the artificial intelligence work we're doing at AliveCor has been deemed so meaningful that it has achieved FDA Breakthrough Device status. We view it as a key milestone in our corporate history and look forward to the further development of our non-invasive Hyperkalemia detection tools," said Vic Gundotra, CEO of AliveCor, in a press release. Press release

Smartphone diagnostic specialist Novarum DX has achieved a significant milestone in the development of its revolutionary technology after being officially granted a European patent. Novarum has been awarded the patent (EP 12718728.4) for its smartphone diagnostic technology by the European Patent Office (EPO), having already secured the equivalent patent for its technology in the United States earlier this year. The patents protect Novarum’s image-capture technology which transforms a smartphone into a diagnostic reader when using the mobile’s camera to accurately scan the results of a rapid test. Press release

Healcerion announced that Primary Care Physicians and other clinicians across the US are using the newly-launched SONON 300L wireless, handheld ultrasound device to accelerate diagnosis, gain deeper insight into patient health and provide a richer patient experience, while increasing revenue through the addition of this service to patients. Healcerion Founder and CEO, Benjamin Jeongwon Ryu, said in a press release, "SONON 300L is ultra-compact and easier to use than any other handheld ultrasound in the US market. By removing prior space and budgetary barriers to acquiring a diagnostic ultrasound device, physicians and patients both benefit." The SONON 300L is available at an unprecedented price point, about 1/10 the cost of a traditional floor-based ultrasound unit, providing affordable, easy-to-use ultrasound technology that was previously out of reach for the budgets of many practitioners. Press release

Prevencio announced data demonstrating its HART PAD test accurately diagnoses peripheral artery disease (PAD) in diabetes mellitus (DM) patients, a patient population in which PAD prevalence has traditionally been difficult to assess. Researchers believe these important findings, presented August 25 at the 2018 European Society of Cardiology (ESC) Congress in Munich, Germany, could lead to early identification of PAD and improve patient clinical outcomes, as well as prevent patients without PAD from undergoing unnecessary, expensive, and invasive tests. The study is follow-on to data presented at the American Diabetes Association (ADA) 2018 Scientific Sessions in June 2018 demonstrating Prevencio's HART CAD and HART CVE tests accurately diagnose coronary artery disease (CAD) and predict the risk for major adverse cardiac events (MACE) in DM patients. Similar to CAD, PAD is commonly due to atherosclerosis, a plaque buildup in the arteries which restricts blood flow. In this study, researchers assessed the company's AI-driven HART PAD diagnostic test on patients enrolled in Massachusetts General Hospital's (MGH) Catheter Sampled Blood Archive in Cardiovascular Disease (CASABLANCA) study. The HART PAD test algorithmically assesses six biomarkers linked to atherosclerosis, as well as a patient's history of hypertension. In patients with DM, the HART PAD panel had excellent performance for diagnosis of PAD. Using a 5-point score, a score of 1 had a 100% Negative Predictive Value (NPV) and a score of 5 had a 95% Positive Predictive Value (PPV). Additionally, the HART PAD panel was highly accurate in predicting the need for revascularization in patients with PAD. These results were comparable to those patients without DM. Press release