October 7, 2021 | New assays for COVID-19 detection and partnerships to increase testing; AI detection tools for prostate cancer, inflammatory bowel disease, rare diseases; and diagnostic partnerships with AstraZeneca, Mount Sinai, and Merck. Plus new products from Proscia, Seegene, Thermo Fisher, Sensyne Health, and more.
Proscia has released study results on new technology that leverages artificial intelligence (AI) to automatically detect melanoma, the deadliest form of skin cancer, with a high degree of accuracy. The findings illustrate the promise of AI to deliver faster diagnoses, improve patient outcomes, and optimize laboratory economics in the routine practice of pathology. Proscia’s prospective study, conducted at Thomas Jefferson University and the University of Florida, demonstrated the real-world performance of the AI on an uncurated set of 1,422 sequential skin biopsies. The technology correctly identified invasive melanoma and melanoma in situ with a sensitivity of 93% and a specificity of 91%. It also classified basal cell carcinoma and squamous cell carcinoma with an AUC of .97 and .95, respectively, accounting for a combined 97% of all skin cancers. This study validated the results of a multi-site retrospective study of 12,784 images, which will be presented during the Computational Challenges in Digital Pathology Workshop at the 2021 International Conference on Computer Vision. Press release.
The U.S. Food and Drug Administration has provided Emergency Use Authorization (EUA) for EUROIMMUN’s Anti-SARS-CoV-2 S1 Curve ELISA (IgG). This assay allows for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G. The Anti-SARS-CoV-2 S1 Curve ELISA (IgG)—based on EUROIMMUN’s Anti-SARS-CoV-2 QuantiVac ELISA (IgG) that received CE mark in November 2020—measures the concentration of antibodies against the S1 domain of the spike protein including the receptor binding domain (RBD), which represents an important target antigen for virus neutralizing antibodies. Due to the low protein homologies within the coronavirus family, the existence of IgG antibodies specifically indicates recent or prior infection and is to be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. For this reason, S1 based tests play a critical role in ongoing vaccine development programs and in research efforts to examine the immunity of individuals previously infected by SARS-CoV-2. Press release.
Takara Bio Europe (TBE) has announced the launch of an in vitro diagnostic assay for the qualitative detection of novel coronavirus (SARS-CoV-2) from patients suspected of having Covid-19, based on real-time reverse transcriptase PCR (RT-qPCR). This CE-IVD kit complies with the Directive 98/79/EC on in vitro medical devices and is available for immediate distribution in selected countries. The Takara SARS-CoV-2 Direct PCR detection kit, which was approved in Japan last year as an in vitro diagnostic kit, has been designed to detect SARS-CoV-2 in a simpler and faster manner. Nasopharyngeal or nasal swab samples, along with crude saliva samples, can be processed directly with this assay without RNA extraction, thus streamlining the protocol and giving a result in just 60 minutes. This kit contains two primer/probe sets specific to the regions of the SARS-CoV-2 nucleocapsid genes (N1 and N2), based on the sequences reported by the Center for Diseases Control and Prevention (CDC)¹. It also includes a primer/probe set to detect the human RNase P (RP) gene as an internal control. The Takara SARS-CoV-2 Direct PCR detection kit uses Takara Bio’s worldwide renowned enzymes to offer reliable results that clinicians can trust. The kit’s simple yet efficient protocol has been tested and validated on commonly used thermocyclers and can accommodate a wide range of samples, making it a versatile and economical solution for all laboratories. Press release.
The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Paige Prostate, a clinical-grade AI solution for prostate cancer detection. As a novel technology, Paige Prostate is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic (IVD) use via Paige’s FDA-cleared FullFocus digital pathology viewer. Paige Prostate is a cancer detection solution that identifies foci suspicious for cancer and provides this information to the pathologist. Paige Prostate is designed to assist pathologists in finding small foci of cancer and enable pathologists to work efficiently and confidently in their diagnostic process. In the clinical study submitted to the FDA, pathologists using Paige Prostate were shown to increase over 7 percentage points in sensitivity in correctly diagnosing cancer (from 89.5% to 96.8%). Pathologists using Paige Prostate had a 70% reduction in false negative diagnoses and a 24% reduction in false positive diagnoses. This improvement was independent of diagnostic sub-specialization or years of experience of the pathologists and whether the analysis was done remotely or on-site. The company plans to submit the full data for publication in a peer-reviewed journal. Press release.
Iterative Scopes has entered into an AI-powered diagnostic tools partnership with the Crohns & Colitis Foundation (the Foundation), the leading patient organization dedicated to improving the quality of life of those affected by inflammatory bowel disease (IBD). A major goal of the relationship is to incorporate the Foundation’s comprehensive repository of data on the patient journey into the company’s next-generation endoscopic tools that have the potential to improve the care of IBD patients worldwide. The partnership gives Iterative Scopes rights to access IBD Plexus, the Foundation’s first-of-its-kind research information exchange platform, for the purpose of delivering artificial intelligence-driven endoscopic solutions to life sciences researchers and healthcare providers. Iterative Scopes intends to collect imaging data from sites participating in IBD Plexus research initiatives to inform its computational models of disease severity scoring algorithms and to further advance its precision medicine initiatives. The results of this work will be eventually integrated with IBD Plexus rich, multi-dimensional data to enable deeper understanding of the full patient journey, which is a key component of the company’s efforts to better predict individual disease progression. Press release.
The National Football League Alumni Association (NFLA) has announced its partnership with mobile cognitive assessment aid HitCheck. A primary mission of NFLA is to inform, assist, and serve players in their post-NFL lives, with a focus on brain health. HitCheck is available to all members of the NFLA. Drawing on established medical research, HitCheck enhances standardized cognitive testing methods and translates them into short, simple mobile cognitive exercises. HitCheck captures, records, and compares these objective, quantitative results with a user’s prior brain performance. Press release.
Seegene has unveiled AIOS, its first fully automated molecular diagnostics system. AIOS provides high-throughput real-time PCR workflow starting from nucleic acid extraction, then real-time PCR, and finally result interpretation. AIOS is fully automated syndromic MDx system designed in a modular concept while it compiles Seegene's cutting-edge high multiplex real-time PCR technologies. A noteworthy feature of AIOS is that its MDx system is composed of independent and detachable modules together with its proprietary SW architecture. Unlike others' single-body system, AIOS is designed with an extraction/liquid handler and PCR instrument being integrated with an in-house developed robotic arm module. Hospitals and laboratories can either purchase the full package of 'AIOS' system or integrate their existing instruments on site if they already have Seegene's liquid handler and real-time PCR instrument. Press release.
NervGen Pharma Corp., a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, has announced a partnership with Imeka Solutions, currently the only neuroimaging company that combines artificial intelligence and diffusion imaging to obtain high resolution images of white matter in the brain. NervGen intends to utilize Imeka’s imaging technology as a sensitive pharmacodynamic biomarker for its lead compound, NVG-291, in its Phase 1b/2 clinical trials. Additionally, the companies are submitting non-dilutive grants that support combining their technologies in preclinical and clinical studies for various conditions related to central nervous system damage. Press release.
Scopio Labs has announced the commercial launch of its FDA-cleared and CE-approved Full-Field Peripheral Blood Smear (FF-PBS) Application on the X100 platform. The application's commercialization is an important step in the company's plan to transform hematology and introduce a new line of digital solutions for cell morphology analysis that enable earlier detection, diagnosis, and treatment for improved patient outcomes. Scopio Labs' FF-PBS application is the first end-to-end digital solution on the market that offers full-field imaging and an AI-powered Decision Support System (DSS) with true remote capabilities. This unique approach streamlines labs' and clinicians' workflows and optimizes the blood smear analysis process. Press release.
KSL Biomedical has acquired Pulse Scientific, a diagnostic products manufacturer and distributor of medical, laboratory and research products located in Toronto. With the incorporation of KSL Biomedical Canada, and the acquisition of Pulse Scientific, KSL extends its international base for product distribution and laboratory sales, positioning the company to merge additional technology, business lines, and acquisition targets in Burlington, the Greater Toronto Area (GTA), and beyond. Pulse Scientific specializes in the manufacturing and distribution of technical microbiology products and controls for clinical, industrial, and pharma customers, as well as in vitro diagnostic (IVD) tests for laboratories and physicians. The company is ISO 13485 certified and licensed by Health Canada, positioning it to distribute medical devices and in vitro diagnostics in Canada, Europe, and many other markets throughout the world. Presenting a number of synergistic opportunities, the acquisition allows KSL to add proprietary products and services to its pipeline, including exclusive diagnostics, laboratory products, medical devices, and assays, utilizing proprietary biomarkers and instrumentation. Press release.
PerkinElmer has announced its collaboration with the Mount Sinai Health System to increase accessibility of SARS-CoV-2 testing in New York City. The laboratory system located at the Mount Sinai Beth Israel hospital campus now has the capacity to process 25,000 (and ultimately up to 100,000) tests per day with PerkinElmer’s instrument and reagents. According to the U.S. Food & Drug Administration (FDA) companion resource, a highly sensitive RT-PCR test should be used for screening asymptomatic individuals. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is the most sensitive commercially available COVID-19 molecular diagnostic test authorized for emergency use, as reported by FDA’s reference panel study, and is ideally suited to support screening programs. Press release.
Genomenon, an AI-driven genomics company, today announced a collaboration with Alexion, AstraZeneca Rare Disease that will make critical information needed for the diagnosis and treatment for a set of rare diseases more readily accessible. The goal of this collaboration is to empower genetic testing labs with the data they need to diagnose patients suffering from rare diseases. The collaboration with Alexion was born out of Genomenon’s mission to ensure that no rare disease patient goes undiagnosed and untreated. Working with Alexion, Genomenon is using its AI-driven genomic technology to produce a complete “Genomic Landscape” for an initial group of rare diseases that includes Wilson disease, Complement-Mediated Thrombotic Microangiopathy (CM-TMA), Lysosomal Acid Lipase Deficiency (LAL-D), and Hypophosphatasia (HPP). The expertly curated genetic datasets for these rare conditions, along with information on available therapies or clinical trials, will then be made available to doctors, researchers, and clinicians through Genomenon’s Mastermind Genomic Search Engine. Press release.
Exact Sciences has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences' ctDNA test to detect MRD. The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences' global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test. Press release.
The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC) who are candidates for EXKIVITY (mobocertinib), a targeted drug developed by Takeda. EXKIVITY is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR Exon20 insertion mutations. It received approval by the FDA on September 15, 2021, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under Accelerated Approval based on overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Press release.
Molecular Health GmbH will collaborate with EONE-Diagnomics Genome Center Co. (EDGC) to help its healthcare provider customers identify personalized treatment options for cancer patients. The collaboration is intended to establish leadership in the fast-growing precision medicine market for liquid biopsy. Therefore, the two partners combine two major proprietary technologies, Molecular Health’s MH Guide and EDGC’s ONCOCATCH-CDx. This allows comprehensive genomic tumor profiling to guide treatment in solid tumors. EDGC is an international joint venture based in South Korea that develops leading-edge technology for genome analysis and precision as well as personalized medicine. With ONCOCATCH-CDx the research and development company developed a unique non-invasive biopsy for early diagnosis, companion diagnostics, and monitoring of all-stage cancer. As part of the cooperation, EDGC aims to utilize Molecular Health’s MH Guide, analysis software that supports oncologists and molecular pathologists in the interpretation of large molecular datasets. Independent of the sequencing technology used, MH Guide can make complex datasets readable, and automatically identify genetic variants that are relevant for the treatment of cancer patients. Press release.
Progenity has announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,112,403 for assessment of preeclampsia using assays for free and dissociated placental growth factor. The patent is directed to methods, compositions, and kits for detecting and measuring free and dissociated placental growth factor (PlGF) levels in biological samples. PlGF is well established as an important biomarker for the assessment of preeclampsia, and recent studies have revealed the importance of distinguishing between the free and bound forms when assessing the complex physiological pathways involved in preeclampsia. The Preecludia test is expected to target an addressable market of up to $3 billion annually in the United States. In addition to the laboratory-developed test (LDT) immunodiagnostic under development, this test has potential as an in vitro diagnostic (IVD) and point-of-care solution globally. Consistent with the company’s recent strategic transformation, Progenity is evaluating commercialization opportunities for launch of the LDT within the United States, and IVD embodiments to access the global opportunity for the Preecludia test. The company previously announced successful completion of the clinical validation study and achievement of the primary study endpoint and is pursuing publication of the study results in a peer-reviewed medical journal. Press release.
Sensyne Health has launched SENSIGHT, an AI enabled global data analytics platform for the healthcare and life sciences sectors. SENSIGHT is built on a rapidly growing deep and broad set of anonymized and de-identified patient data derived from the research partnerships Sensyne has entered into with NHS Trusts and US health systems that currently covers 22.5 million patients across a range of disease areas. The power and affordability of the SENSIGHT platform represents a disruptive shift in how the life science and healthcare communities will access and leverage clinical data insights, collaborate with their colleagues, and advance the state of care and discovery. The platform provides clinicians, research academics and life science professionals with an instant AI research capability to analyze health insights across a curated common data environment, underpinned and protected by a rigorous information governance and security framework. No direct patient data is, or ever will be, shared on SENSIGHT. The platform instead rapidly interrogates Sensyne’s deep diverse datasets and delivers intelligent analytics and data-driven insights, not the data itself. Subscribers will be screened to ensure legitimate interest, with only those in accredited companies and organizations being accepted. Researchers can communicate and collaborate with each other on the platform, creating a virtual scientific research network that connects professionals across the healthcare and life sciences industries creating a community with common interests in particular research fields or areas of unmet medical need. Press release.
Thermo Fisher Scientific's clinical sequencing business and AstraZeneca are working to co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement. Press release.
LumiraDx has announced the US launch of its COVID-19 Surveillance Test for environments such as schools and workplaces. The LumiraDx SARS-CoV-2 Ag Surveillance Test allows simultaneous testing of up to five samples on a small, portable instrument with cost per sample as low as $4. With digital results in less than 12 minutes from sample application and a comprehensive connectivity solution, it is designed to measure population health metrics in real-time to help prevent the spread of infection using an affordable, easy-to-use, onsite testing platform. Details of LumiraDx’s COVID-19 diagnostic and surveillance testing options are also available through Open and Safe Schools, in partnership with The Rockefeller Foundation’s National Testing Action Program (NTAP), to support state public health and school leaders to leverage federal government programs and resources and implement school COVID-19 testing programs to safely reopen and stay open. Press release.
Illumina and Merck have announced a partnership to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD). Patients whose tumors are HRD-positive may be eligible for targeted treatment by a class of precision medicines called PARP inhibitors. The HRD tests will leverage Illumina's TruSight Oncology 500 (TSO 500) content, enabling the most comprehensive genomic profiling assays in a single workflow. This strategic partnership builds on an initial study conducted with Merck and leverages Illumina's relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad's FDA approved myChoice CDx companion diagnostic test. Illumina will develop a new HRD CDx test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status who are eligible for treatment with LYNPARZA (olaparib), a first-in-class PARP inhibitor, jointly developed and commercialized by Merck and AstraZeneca. In addition, Illumina will develop and commercialize a research use only (RUO) HRD assay that will be add-on content for the TSO 500 RUO panel. Illumina plans to launch this product globally, excluding the United States and Japan. Press release.