July 30, 2020 | July featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Thermo Fisher Scientific, Proscia, and more.
Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test in Japan. The CDx will be leveraged to identify ROS1-positive non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with entrectinib (Rozlytrek). Approval by the MHLW would accelerate access to Chugai's targeted therapy via a locally administered, next-generation sequencing (NGS) biomarker test. Entrectinib received MHLW approval in February 2020 to treat ROS1-positive NSCLC adult patients. Prior to that, the drug received accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2019 to treat ROS1-positive NSCLC adult patients, and both adult and pediatric patients with solid tumors that have NTRK gene fusions. ROS1 gene fusions are prevalent in 1-2% of NSCLC cases. It is one of 46 cancer-related biomarkers evaluated by the MHLW-approved version of Thermo Fisher's Oncomine Dx Target Test. The MHLW previously approved the test as a CDx for four biomarkers – EGFR, ALK, ROS1 and BRAF – associated with 12 targeted therapies for NSCLC. The test was previously approved to identify ROS1-postitive patients for treatment with crizotinib in the U.S. Press release
Proscia is collaborating with Royal Philips to advance an open ecosystem that helps laboratories accelerate and scale digital pathology adoption. Through the collaboration, Proscia will integrate the Philips Pathology SDK to natively utilize Philips’ iSyntax image format with its Concentriq digital pathology platform and suite of AI modules, providing users of Philips' digital pathology solutions with expanded options to meet their business and workflow needs. As laboratories shift to digital pathology, they are implementing a sophisticated ecosystem of hardware and software solutions to address the end-to-end pathology workflow. These laboratories are increasingly demanding an open approach focused on interoperability to centralize pathology operations while gaining the flexibility needed to meet current and future requirements. By incorporating the Philips medical-grade iSyntax image format into Concentriq, Philips and Proscia are providing laboratories with the freedom to choose the best components of an integrated digital pathology ecosystem and realize added value from their images. Concentriq is an open digital pathology platform used by leading commercial and academic laboratories, as well as research organizations, to view, manage, and analyze whole slide images at an enterprise scale. In addition to offering seamless integration with multiple image formats, now including iSyntax, Concentriq is interoperable with whole slide image scanners, laboratory information systems, and image analysis applications. The platform also serves as a launchpad for computational pathology applications leveraging artificial intelligence, including solutions developed by Proscia and other third parties. Press release
Renalytix AI announced that it has signed an agreement to become a provider in the America's Choice Provider Network (ACPN). ACPN contracts directly with healthcare providers of all types and specialties to establish simple and reliable healthcare access and reimbursement arrangements. It is one of the largest preferred provider networks in the United States with members and providers in all 50 states and agreements with over 1,700 payers. Under the agreement, RenalytixAI will now be able to offer KidneyIntelX testing to diabetic kidney disease patients among ACPN's more than 30 million members in the U.S. This is an important step in RenalytixAI's strategy to put in place the necessary framework in order to secure broad insurance network coverage and, in turn, adoption of KidneyIntelX ahead of its planned roll-out to additional health systems. Press release
LexaGene announced the name and first look of the Company’s flagship product, called MiQLab, which is being manufactured for an anticipated commercial launch prior to the end of September 2020. MiQLab is a fully automated genetic analyzer that is designed to deliver reference-quality data at the point-of-need. MiQLab’s technology screens samples for up to 27 different targets at once—looking for pathogens and/or antimicrobial resistance factors—and returns results in approximately one hour. It is designed to be operated at the site of sample collection to avoid the delay associated with shipping and manually processing samples. This technology is designed for use in multiple markets, including human and veterinary diagnostics, as well as food safety testing. MiQLab is open-access, which allows users to customize their tests easily. Scientists who have custom testing needs make up the open-access market, and they currently spend hours a day to manually perform PCR testing. These same individuals will now have the opportunity to save hours a day by having MiQLab automate the processing of their own tests. Press release
LGC announced the acquisition of The Native Antigen Company (NAC). NAC is a developer, manufacturer and supplier of critical reagents to the in vitro diagnostic (IVD), pharmaceutical and academic sectors. It offers a comprehensive portfolio of native and recombinant infectious disease antigens and related products including pathogen receptors, virus-like particles and antibodies for use in immunoassay applications, vaccine development and quality control solutions. In a press release, Michael Sweatt, Executive Vice President and General Manager, Clinical Diagnostics, LGC, said, “NAC is a natural fit with our clinical diagnostics business and will enable us to provide an expanded portfolio of critical reagents to our customers. NAC’s focus on infectious disease is highly complementary with our existing offer to this segment comprising controls, reference materials, MDx tools and other components. We are excited to welcome our new colleagues into our organization.” Press release
The latest update to the 2bPrecise precision health platform includes functionality to help oncologists identify genetic factors indicating patient risk for secondary cancers, as well as elevated risks for the patient’s family members. Testing tumor tissue (somatic data) to assist in precise diagnoses and targeted treatments has been a standard of cancer care for years. However, these somatic results may also contain incidental information about mutations contained within the patient’s genetic profile. Presence of these complex mutations typically indicates a need for patients to undergo germline testing, not only to better understand their own cancer susceptibility but to uncover information about heritable variants that should be shared with biological relatives. Since its development, the 2bPrecise platform has delivered somatic results into the oncology workflow, supporting clinical decision making to shorten the disease-burden timeline and improve outcomes. With the release of v3.0, 2bPrecise is bringing knowledge and NCCN- and ACMG-guidance into the workflow so oncologists will be able to refer patients to a genetic counselor for additional genomic testing when germline variants are found in the somatic results. Press release
The European Centre for Disease Prevention and Control (ECDC) is working in close collaboration with the World Health Organization to monitor the progress towards the elimination of hepatitis B (HBV) and C (HCV) across the EU/EEA. The first progress report highlights major gaps in prevention programs in the region with suboptimal HBV vaccination coverage and insufficient levels of harm reduction targeting people who inject drugs. The report shows that robust data for the so-called continuum of care looking at the numbers of diagnosed people and those in treatment and care are lacking in most countries. However, available data suggest that a high proportion of people living with hepatitis B and C infections appear to be undiagnosed and that many of those who have been diagnosed with hepatitis B and C infection are not receiving life-saving treatment. Available evidence also indicates that those at high risk of infection, including people who inject drugs and people in prison, are not being effectively targeted for testing. Press release
A 2020 report from the Centers for Disease Control estimates that 1 in 54 children in the United States is identified each year with autism spectrum disorder (ASD). While children can be diagnosed with ASD as early as 2 years old, most children are still being diagnosed after the age of 4. Led by Nancy Swigonski, MD and Mary Ciccarelli, MD, a team of faculty at Indiana University School of Medicine have developed a statewide early ASD screening and evaluation system in the primary care setting showing success in improving access to evaluations and lowering the age of diagnosis. This study, published July 6 in Pediatrics, is the first of its kind in the U.S. to include health care systems across an entire state. "One of the unique aspects of this effort is its scale. While similar innovative diagnostic approaches have previously been tested across the country, our primary-care based Early Autism Evaluation hubs provide data representing much of the state of Indiana," said Rebecca McNally Keehn, lead author on the Pediatrics study, in an official statement. "By improving access to earlier high-quality diagnostic evaluations in children's local communities, our hope is that children will be enrolled in evidence-based interventions that can improve developmental outcomes here in Indiana." Press release
An updated cervical cancer screening guideline from the American Cancer Society reflects the rapidly changing landscape of cervical cancer prevention in the United States, calling for less and more simplified screening. The updated guideline recommends that individuals with a cervix initiate cervical cancer screening at age 25 and that primary human papillomavirus (HPV) testing (HPV testing without the Pap test) every 5 years be the preferred method of testing through age 65. The guideline says using HPV testing in combination with a Pap test (called cotesting) every 5 years or Pap tests alone every 3 years are acceptable options for now, as not all labs have transitioned to primary HPV testing. “These streamlined recommendations can improve compliance and reduce potential harms,” said Debbie Saslow, managing director, HPV & GYN Cancers for the American Cancer Society, in an official statement. “They are made possible by some important developments that have allowed us to transform our approach to cervical cancer screening, primarily a new understanding of the role of HPV and the development of tools to address it.” Press release