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Quest Diagnostics, MDxHealth, QIAGEN, And More: News From June 2017

June 29, 2017 | June featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Quest Diagnostics, MDxHealth, QIAGEN, and more.

MDxHealth announced the launch in Europe and other markets of the SelectMDx for Prostate Cancer in vitro diagnostic (IVD) PCR kit with CE-marked components and CE-marked UrNCollect device. The IVD PCR kit will enable diagnostic laboratories with manual and automated RNA extraction and PCR platforms to perform the SelectMDx liquid biopsy test in their own facility. The CE-marked UrNCollect device is a unique, user-friendly and compact collection tool that complements the IVD kit by enabling easy and efficient sample collection. Press release

QIAGEN announced the U.S. regulatory approval of QuantiFERON-TB Gold Plus (QFT-Plus) the fourth generation of the market leading blood test for detecting latent tuberculosis (TB) infection. The approval by the U.S. Food and Drug Administration (FDA) comes after QIAGEN submitted the test in a pre-market approval (PMA) supplement in late 2016, and the U.S. commercialization of the fourth-generation test is planned to begin later this year. With the addition of proprietary CD8+ technology, QFT-Plus represents a key milestone in the development of diagnostic tests for latent TB infection. For the first time, a test has the potential to offer the ability to capture a much broader picture of an individual's immune response to TB infection. This technological advancement is critical to improving the understanding of how the immune system reacts to TB infection, and is expected to set a new standard for future disease management. Press release

HeartFlow announced that Blue Cross Blue Shield (BCBS) Association’s Evidence Street has issued a positive healthcare evidence review of the company’s HeartFlow FFRct. This non-invasive technology is the first to provide insight into both the extent of coronary artery disease (CAD) and the impact the disease has on blood flow to the heart. It combines anatomic information from a coronary CT angiogram and physiology from HeartFlow FFRct to enable clinicians to select an appropriate and personalized treatment for each patient. The Evidence Street review assessed the technical performance, diagnostic accuracy and clinical utility of HeartFlow FFRct and determined that it provides a meaningful improvement in net health outcome when used to guide the care of patients with stable chest pain who are at intermediate risk of CAD and are being considered for invasive coronary angiography. Press release

Quest Diagnostics announced that it has signed definitive agreements to acquire two laboratory businesses in Lewisville, Texas, with the aim to establish a center of excellence providing diagnostic services to aid the detection and management of cancer for oncologists and patients nationwide. The two businesses, Med Fusion and Clear Point, together provide a full range of diagnostic services to physicians and provider networks. Baylor Scott & White Health (BSWH)The US Oncology Network (The Network); Texas Oncology; and Pathologists Bio-Medical Laboratories (PBM) are co-owners of one or both businesses. Upon the completion of the transaction, Quest will become a preferred provider of advanced oncology diagnostics for The Network, including Texas Oncology. The Network is the largest of its kind, consisting of more than 400 locations across the United States and over 1,400 independent, community-based physicians. The advanced diagnostics Quest will provide include genomic and pathology testing, such as tumor sequencing, typically used by oncologists to select and monitor treatment and predict disease progression. Inherited genetic testing, such as for BRCA breast cancer screening, typically offered by non-oncologists, will not be part of a preferred provider relationship. Press release

Medial EarlySign announced a strategic collaboration with Medicover to identify individuals at high risk of harboring colorectal cancer (CRC). Medicover selected Medial EarlySign's ColonFlag tool for a pilot project after learning of its scientific retrospective analysis and validation for identifying individuals that should be tested for disease. ColonFlag applies advanced AI and machine learning algorithms to large amounts of ordinary medical data, such as total blood test results and other EHR data, flagging high-risk individuals for further evaluation. Press release

Sophia Genetics has unveiled a new AI-powered solution for liquid biopsies. This new application taps the analytical power of the company’s artificial intelligence, SOPHiA, to help clinicians diagnose, treat, and monitor cancer earlier and more effectively by looking at circulating tumor DNA (ctDNA), or circulating tumor cells (CTC), contained in patients’ liquid samples such as blood, urine, and cerebral spinal fluid. Press release

Thermo Fisher Scientific strengthened its leadership in mass spectrometry by launching new technologies to advance cutting-edge research and improve results in applied markets during the 65th Annual American Society for Mass Spectrometry (ASMS) Conference. New options for the award-winning Thermo Scientific Orbitrap Fusion Lumos mass spectrometer can expand instrument power, performance and versatility. Used primarily in the structural characterization of large and small molecules, the system includes a new, integrated Ultraviolet Photodissociation (UVPD) feature that is standard on new systems and available as an upgrade to existing Fusion Lumos instruments. This unique fragmentation mode is designed to improve productivity and provide researchers with accurate structural information. Press release

MDxHealth announced that it has signed a scientific agreement with QUT bluebox, the commercialization arm of the Queensland University of Technology (QUT), to develop a liquid biopsy epigenetic assay for the early detection of oral cancer. The test evaluates abnormal DNA methylation changes which is an early event seen in tumor progression. Methylation of DNA is one way that cells regulate gene activity and abnormal methylation indicates a patient may have a higher risk of developing cancer. Press release

Cancer Genetics (“CGI” or “The Company”) announced the launch of Thermo Fisher Scientific's (Thermo Fisher) Oncomine Dx Target - the first next-generation sequencing (NGS)-based Companion Diagnostic (CDx) test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC). CGI is one of the first laboratories, one of only three, in the USA to offer Thermo Fisher’s Oncomine Dx Target Test. Press release