April 30, 2018 | April featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Foundation Medicine, QIAGEN, Curetis, and more.
Foundation Medicine announced that the US Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies. “Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for patients with advanced cancer. A critical need exists for non-invasive solutions for these patients to help guide the use of both targeted and immunotherapies. After successfully completing the parallel review process with FoundationOne CDx for solid tumors, we’re pleased to continue our work with the FDA applying this expertise to our liquid biopsy franchise with the potential to offer oncologists multiple FDA-approved options that enable biomarker-driven care and ultimately better outcomes for patients,” said Vincent Miller, chief medical officer at Foundation Medicine, in a press release. “The acceptance of this assay for Breakthrough Device designation is an important step to advancing precision medicine options for patients, including the potential intended use as a companion diagnostic across multiple types of cancer, which will also help our biopharma partners accelerate their development efforts for these programs.” The new liquid biopsy assay is a next generation sequencing-based in-vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and blood tumor mutational burden (bTMB) using circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood. The company plans to seek approval of the assay for use as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with the approved therapeutic product labeling and to provide tumor mutation profiling to be used by qualified health care professionals following the professional guidelines in oncology for patients with malignant neoplasms. Press Release
QIAGEN announced the launch of QIAstat-Dx in Europe, providing a one-step, fully integrated molecular analysis of common syndromes as tested for in syndromes in infections, oncology and other diseases. The launch follows the closing of the acquisition of Stat-Dx announced in January 2018 and the successful completion of defined development activities by Stat-Dx. Further details of the transaction were not disclosed. QIAstat-Dx (formerly Stat-Dx DiagCORE) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE technology, received CE-IVD marking in January 2018 and already has a significant installed base among early adopters. QIAstat-Dx is now being launched with an upgraded CE-IVD-marked respiratory panel that detects 21 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx which spans infectious diseases, oncology, companion diagnostics and other disease areas. “We are pleased to launch QIAstat-Dx and are excited about its features and capabilities which position it as the next generation of innovation for multiplex syndromic testing,” said Peer M. Schatz, Chief Executive Officer of QIAGEN, in a press release. “We are today launching in Europe and expect to have launched QIAstat-Dx system in most countries worldwide by the first half of 2019, including in the United States, and subject to regulatory clearances. A very promising pipeline of future applications and assays will add exciting value to our customers, including capabilities and assays in companion diagnostics and oncology, as well as in quantitative analysis and immunoassay testing.” Press Release
Curetis announced that the Company has been granted a De Novo clearance by the US Food and Drug Administration (FDA) to market the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the US. The sample-to-answer Unyvero System together with the Unyvero LRT Application Cartridge provides rapid infectious disease testing directly from aspirate samples in under five hours. It covers more than 90% of infection cases of hospitalized patients with pneumonia and provides clinicians with a comprehensive overview on genetic antibiotic resistance markers detected. As the first-in-class molecular test for lower respiratory tract infections with no direct MDx competition, it addresses a high unmet medical need that generates over $10bn in annual costs for the U.S. healthcare system. It is also the first time the FDA has granted an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae. In sum, Unyvero is expected to impact clinical outcomes, support antibiotic stewardship and create health economic benefits. The Company has a team of more than 20 seasoned experts already in place at its Curetis USA Inc. subsidiary in San Diego, CA. These experts include the U.S. executive leadership, regional sales directors, clinical application specialists, and field-based territory sales managers and service engineering and logistics support. Commercial roll-out will start early in the second quarter, with initial placement opportunities expected in the same quarter. Curetis targets to place 60 to 80 Unyvero Analyzers in the U.S. within the first full year of commercial availability. "The launch of our Unyvero System and LRT Application Cartridge in the United States will address a pressing unmet medical need as it delivers results much faster than current standard of care microbiology culture," Curetis' co-founder and Chief Operating Officer, Johannes Bacher, in a press release. "We expect that the LRT panel will transform our approach to the diagnosis of lower respiratory tract infections", said Donna Mildvan, Infectious Diseases Physician and Clinical Professor of Medicine at Icahn School of Medicine at Mount Sinai. "Having the opportunity to characterize pneumonia by knowing the causative organism as well as relevant antibiotic resistance markers in 4 to 5 hours has great clinical implications - it is game changing and exciting." Press Release
Qure.ai launched a new AI-powered technology to accurately identify bleeds, fractures and other critical abnormalities in head CT scans. Qure.ai has also released the results of an unprecedented clinical validation study confirming its algorithms' near-radiologist performance on 21,000 patients and has made a dataset of almost 500 AI-analyzed head CT scans available for download. A CT scan of the head is usually the first diagnostic test patients undergo if they have a head injury or symptoms suggesting stroke. The problem, however, is that radiologists might not be immediately available to read a scan or might have many scans pending. Prompt reading of the CT scan is critical for stroke patients, as every minute that goes by, brain cells die. "Qure.ai's new head CT scan technology rapidly screens scans in under 10 seconds to detect, localize and quantify abnormalities, as well as assess their severity," said Prashant Warier, Co-Founder and CEO, Qure.ai, in a press release. "This enables patient prioritization and the appropriate clinical intervention." Press Release
XIFIN announced a strategic partnership with PriorAuthNow to bring an integrated, automated and simplified prior authorization process to diagnostic laboratories for the first time. The integration of PriorAuthNow’s platform with XIFIN RPM 9’s intelligent automation will optimize the process for both hospital-based and independent labs handling test orders that require prior authorization. This partnership makes XIFIN RPM the only diagnostic laboratory revenue cycle management solution with an automated and integrated prior authorization solution to reduce denials, accelerate reimbursement, improve workflow, and make the overall process simple and transparent. Traditionally, the prior authorization process has been disconnected and time-consuming, requiring high levels of manual work, such as phone calls to insurers and sifting through pages and pages of medical records – ultimately delaying patient care. In addition, next-generation sequencing and complex molecular diagnostic tests that require prior authorization are becoming more common, exacerbating the prior authorization challenge. Each year, $31 billion is spent on prior authorizations, and 40% of prior authorizations are abandoned due to complex approval policies. The combination of XIFIN RPM 9’s intelligent automation with PriorAuthNow’s platform will streamline this process and directly impact diagnostic laboratories’ bottom lines through improved reimbursements rates and decreased administrative labor costs for complex diagnostic tests. “Both hospital-based and independent labs are seeing a steady increase in more complex test orders, such as genetic testing. They need a more efficient way to secure the required prior authorizations on these tests, allowing patients to obtain important diagnostic information in a timely manner while securing the appropriate reimbursement,” said Lâle White, CEO, XIFIN, in a press release. “By partnering with PriorAuthNow, we’re addressing this shift in the healthcare market and giving labs, ordering physicians, patients and payors significant improvements into the prior authorization process, delivering notable clinical and financial value.” Press Release
Proscia and Proteocyte AI announced they have signed a partnership agreement to integrate Proscia's technology with Straticyte, a specific test for predicting the risk of progression to oral cancer. Proteocyte AI will leverage Proscia's cloud-based platform to orchestrate workflows of patients, doctors, and laboratories, enabling Proteocyte AI to offer a more comprehensive solution. "Oral cancer can be a devastating disease. We know that early detection can make the difference for oral cancer patients yet we've had a gap in technology in terms of predicting which oral lesions will transform to oral cancer. Straticyte provides us with more information so that treatment plans can be further personalized and outcome for patients may improve," said Kevin Lung, Oral Maxillofacial surgeon at Kingsway Oral and Maxillofacial Surgery Clinic in Edmonton, Alberta, Canada, in a press release. Proteocyte AI is focused on combining artificial intelligence and protein biomarkers to determine a patient's five-year risk of developing cancer. This technology predicts who is at risk to develop cancer before they actually have cancer. Press Release