May 24, 2023 | AI in diagnostics partnerships from Cardio Diagnostics Holdings, Paige, and Visiopharm; Quest makes RestoreU Dementia Panal nationally available; Spanish groups release prognosis calculator for multiple myeloma. Plus: new products from Thermo Scientific, Aetion, Gyros Protein Technologies, and more.
The U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication. These new assays are designed to be used along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy to determine if they are at risk of progressing to preeclampsia with severe features within the next two weeks. Press release.
The Association for Molecular Pathology (AMP) has published a report that was designed to establish recommendations for standardizing orthogonal confirmation practices for germline variants detected by next-generation sequencing (NGS). The manuscript, “Recommendations for Next-Generation Sequencing Germline Variant Confirmation: A Joint Report of the Association for Molecular Pathology and National Society of Genetic Counselors,” was released online ahead of publication in The Journal of Molecular Diagnostics. The AMP Clinical Practice Committee convened the NGS Germline Variant Confirmation Working Group to assess current evidence and standardize orthogonal confirmation practices to help limit the reporting of false positives. The new report offers eight recommendations that are based on a comprehensive review of published literature, empirical data, current laboratory practice surveys, feedback from open public comment, and professional experiences including: clinical laboratories offering germline testing using NGS should establish a written policy regarding orthogonal confirmation of NGS results, laboratories’ orthogonal confirmation policy should be overseen and approved by a qualified and appropriately certified medical professional with training and experience in NGS, and more. Press release.
Tasso, the leading provider of patient-centric, clinical-grade blood collection solutions, has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program. The certification confirms Tasso’s compliance with the standards and regulatory requirements of Australia, Canada, and the United States, opening potential new global markets for Tasso. Press release.
Form Bio has been selected to help organizations adopt Google Cloud’s Multiomics Suite. Multiomics provides an integrated perspective to power discovery across life sciences research domains. Organizations will have an option to incorporate Form Bio's innovative platform when adopting Google Cloud’s Multiomics Suite. The collaboration with Google Cloud will combine ease of use with comprehensive analysis of genetic and proteomic data, expediting biopharmaceutical research. Press release.
Cardio Diagnostics Holdings, an artificial intelligence-powered precision cardiovascular medicine company, has introduced the Actionable Clinical Intelligence (ACI) platform to expand the information available to clinicians prescribing the Epi+Gen CHD and PrecisionCHD laboratory developed tests (LDTs). ACI offers new data-driven insights into the epigenetic and genetic molecular underpinnings of coronary heart disease (CHD). Epi+Gen CHD and PrecisionCHD are artificial intelligence (AI)-driven integrated epigenetic-genetic LDTs for the risk assessment and detection of CHD, respectively. ACI’s analytics framework integrates LDT results with a patient’s unique epigenetic and genetic biomarkers and clinical information to provide deeper and actionable insights to clinicians about factors driving the patient’s CHD. Press release.
Personalis, National Cancer Center, and Ono Pharmaceutical Co., have entered into a collaborative agreement to examine the efficacy and safety of nivolumab, an immune checkpoint inhibitor, for resectable rectal cancer with mismatch repair deficiency (dMMR). As part of the collaboration on the VOLTAGE-2 study, an exploratory analysis will be conducted to evaluate specific biomarkers such as minimal residual disease (MRD) status that may have prognostic or predictive value for patient care. Under the agreement, National Cancer Center Hospital East (NCCHE) will recruit patients and conduct the clinical trial, Ono will provide nivolumab, and Personalis will perform MRD and biomarker testing. Biomarker research will be conducted throughout the study, including sample analysis from both tumor lesion tissue and plasma circulating tumor DNA (ctDNA). The Personalis NeXT Personal platform will be used to correlate MRD status with standard of care imaging and drug response data by monitoring variances in ctDNA. Tissue samples will be analyzed by the Personalis ImmunoID NeXT platform to capture tumor molecular profile and tumor microenvironment features to better understand immunotherapy responses. Press release.
Aetion has launched Aetion Discover, a new application for exploratory analysis. The application provides users with an intuitive interface to generate swift hypotheses and insights across the biopharmaceutical and medtech lifecycle. As with Aetion Substantiate — also built on Aetion Evidence Platform — Discover powers results that are rapid, reliable, and scalable. In developing and commercializing assets, scientists, technologists, and analysts seek faster and simpler ways to understand large, longitudinal data sets and the insights these data hold. With Discover, users can view, assess, and select datasets for their specific analytic objective. Within and across datasets, users can define and describe populations of interest, and obtain and interpret results on any number of mission- and job-critical questions, such as label expansion-related hypothesis generation. Press release.
Paige is working with Visiopharm, an artificial intelligence (AI)-driven precision pathology software provider, to bring a wider range of AI products to doctors and patients. Visiopharm’s AI applications will be deployed and natively integrated into the Paige Platform to be accessed through FullFolio, Paige’s AI-powered clinical worklist, and viewed within FullFocus, Paige’s whole-slide image viewer. This deep integration offers users greater diagnostic efficiency and quality insights when reviewing IHC-stained slides and creates a seamless user experience for Visiopharm’s image analysis applications, to help pathologists deliver faster, more accurate and more reproducible cancer diagnoses. The Paige Platform is interoperable and designed to enable labs to deploy AI-based diagnostic products from AI vendors like Visiopharm, creating one seamless pathology workflow from a single interface. Press release.
Quest Diagnostics has announced nationwide availability of the RestoreU Dementia Panel, a risk assessment and care plan service created by uMETHOD Health, a health technology company specializing in precision medicine for chronic diseases, to help physicians close care gaps for patients with cognitive decline. The RestoreU service employs artificial intelligence (AI) developed by uMETHOD to create personalized care plans aimed at helping physicians improve patient care while also satisfying cognitive care guidelines. The service incorporates results of laboratory tests ordered by physicians from Quest Diagnostics along with the patient’s health history, including comorbidities, lifestyle habits and medications. uMETHOD’s AI platform then assesses 50-plus risk factors, pinpointing areas of concern and ultimately generating a personalized care plan with evidence-based, actionable treatment recommendations. Press release.
Researchers from Cima and Clinica University of Navarra have developed a calculator that identifies patients with multiple myeloma and light-chain amyloidosis with a better prognosis because they have a more benign profile. This tool, designed in collaboration with the Spanish Myeloma Group (GEM-PETHEMA), could become part of the diagnostic workup of these patients. The group hase developed an open access online tool that allows hematologists worldwide to classify patients using routine flow cytometry data. Flow cytometry discriminates residual normal plasma cells and tumor cells with high accuracy. Press release.
Gyros Protein Technologies AB has announced the introduction of Gyrolab Generic Cyno Anti-Drug Antibodies (ADA) Kit Reagents, for the detection of circulating immune complexes of human IgG with cyno anti-human IgG. The new ready-to-use kit reagents streamline pre-clinical development of antibody-based therapeutics, enabling immunogenicity screening of drug candidates without the need for drug-specific ADA assay development. The new kit expedites bioanalysis by removing the need for assay development and optimization across molecules to provide robust, reproducible, reliable data from nanoliter sample volumes. This is beneficial when ADA assessment is evaluated in pre-clinical animal models where sample volume may be limited. Press release.
Personalis has partnered with the Academic Breast Cancer Consortium (ABRCC) and Criterium to carry out a prospective clinical trial, B-STRONGER-1 (Breast Cancer-Minimal Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I), to evaluate the clinical performance of the NeXT Personal test for detecting minimal residual disease (MRD) during and after treatment and recurrent cancer in patients with early-stage resectable triple-negative breast cancer (TNBC). NeXT Personal leverages next-generation sequencing technology to detect ctDNA in the bloodstream and may enable detection of micrometastases that currently evade pCR detection. The assay is designed to deliver industry-leading MRD sensitivity down to 1 part-per-million, an approximately 10- to 100-fold improvement over other available technologies. This may enable earlier detection across a broader variety of cancers and stages. Press release.
Charles River Laboratories International has launched Accugenix Next Generation Sequencing for Bacterial Identification and Fungal Identification (Accugenix NGS). Accugenix NGS simultaneously sequences millions of individual DNA fragments from a sample and provides key information to pharmaceutical and personal care manufacturers regarding microbial control. Charles River recently entered into partnerships with MPL - Mikrobiologisches Prüflabor (Austria) and Sure Laboratories (The Netherlands) to provide regional access to rapid, accurate microbial identifications to the industrial microbiology market, including pharmaceutical, biopharmaceutical, personal care and other global manufacturing industries. Customers of MPL and Sure Laboratories will now be able to leverage the robust Accugenix sequence and MALDI-TOF databases, consisting of relevant species that frequently occur in sterile and nonsterile manufacturing environments. Both databases are regularly updated to provide the most accurate and taxonomically correct identifications. Press release.