January 26, 2023 | A digital AI platform to enrich breast cancer grading and improve risk categorization; novel tests significantly reduce hospitalization costs and mortality and morbidity rates in newborns and premature infants; the first blood test superior to stool tests in detecting advanced adenomas and colorectal cancer; and more.
Agilent Technologies announced an agreement with Quest Diagnostics. The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing test, a single-site premarket approved test. ctDx FIRST is the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI. KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy, as determined by an FDA-approved test. ctDx FIRST is also FDA-approved for tumor profiling of the epidermal growth factor receptor gene under professional guidelines in oncology for patients with advanced NSCLC. As a professional service, the ctDx FIRST test report includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions. Press release.
PreciseDx announced its recent publication in Breast Cancer Research (DOI: 10.1186/s13058-022-01592-2), demonstrating the ability of its digital AI platform to enrich breast cancer grading and improve risk categorization. The population-based longitudinal clinical development and validation study determined the PreciseDx Platform improved risk stratification and prediction of disease recurrence over standard histologic grade and clinical features and demonstrated the ability to supplement molecular genomic tests. PreciseDx's Platform, which leverages its Morphology Feature Array, has proven the ability to enhance pathology interpretation with objective, quantifiable, and highly accurate data. This provides more robust information regarding patient disease status, representing the next generation of pathology analysis. Press release.
Strata Oncology announced that Gilead Sciences agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH) trial by providing TRODELVY (Sacituzumab govitecan-hziy) for eligible patients with cancer. Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Several biomarkers are being considered, including quantitative RNA and multivariate algorithms that may optimize the use of different anti-cancer therapies. These biomarkers can be analyzed in parallel with the genomic mutations assessed by comprehensive genomic profiling, thus maximizing the information available from often limited tumor tissue samples. Press release.
Proscia announced that the Netherlands Cancer Institute (NKI) would deploy its Concentriq Dx platform. NKI is transitioning to Concentriq Dx to expand its digital pathology practice, laying the foundation for its pathologists to deliver personalized diagnoses that better inform treatment decisions. In doing so, the cancer center, which houses an internationally acclaimed research institute, will generate additional pathology data that can lead to clinical breakthroughs. NKI will draw on the platform’s world-class interoperability to unify images from disparate scanners, bringing more pathology data into its practice. Press release.
CellMax Life announced positive results from a multisite U.S. study that showed that its FirstSight blood test is highly accurate in detecting colorectal cancer and advanced adenomas. CellMax’s FirstSight is the first blood test superior to stool tests in detecting advanced adenomas and colorectal cancer. It can detect advanced adenomas by combining signatures from ctDNA and methylation along with rare epithelial cells shed from adenomas using the company’s proprietary circulating epithelial cells technology. Based on clinical data showing FirstSight’s ability to detect both colorectal cancer and advanced adenomas with high sensitivity, CellMax received Breakthrough Device Designation from the U.S. Food and Drug Administration in Q3 2021. Press release.
Intricon announced the launch of a new Biosensors Center of Excellence (CoE). The new CoE combines Intricon’s biosensor device expertise and capabilities into a vertically integrated business unit focused exclusively on bringing Biosensor devices to the medical market. The Intricon Biosensor CoE team has deep knowledge in high-density microelectronics, miniaturization, ultra-low power, miniature molding, firmware development, and wireless communication, including Bluetooth and Bluetooth Low Energy technology. Intricon’s other sensor-driven expertise is developing and manufacturing medical devices that use electromagnetic navigation. The company has proprietary modeling and engineering systems to design and produce micro-coils that meet electromagnetic goals such as induction, resistance, sensitivity, and localization performance. Press release.
Paige announced a collaboration with Microsoft to apply the power of artificial intelligence (AI) to digital pathology images to develop and deliver a new generation of clinical applications and computational biomarkers to transform cancer diagnosis and patient care. Microsoft will also invest in Paige to accelerate the development and deployment of life-saving AI diagnostics. Paige will use Microsoft Azure as its cloud provider for the Paige Platform, a comprehensive solution to power a lab’s digital pathology workflow that consists of data management, cloud storage options, and FullFocus, an FDA-cleared whole-slide image viewer. As part of this collaboration, Paige will become a Microsoft Cloud for Healthcare partner and enable Microsoft to enhance its offerings for healthcare customers. Paige is also working with Nuance, a Microsoft company, on integrating their offering with Nuance’s Precision Imaging Network. Together with Nuance, healthcare organizations can access the broadest and deepest set of trusted AI solutions to address the biggest challenges in the industry. Press release.
Agilent Technologies announced a partnership with Akoya Biosciences to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and to commercialize workflow solutions for multiplex assays in the clinical research market. Integrating Agilent’s Dako Omnis (autostaining instrument) and Akoya’s PhenoImager HT (imaging platform) for multiplex chromogenic immunohistochemistry and immunofluorescent assays will create a singular end-to-end commercial workflow, including reagents, staining, imaging, and analysis. These assay solutions will enable researchers and medical professionals to address patient selection needs of novel therapeutics and rapidly translate their discoveries into clinical testing. This agreement will deliver an end-to-end multiplex solution for biomarker clinical research enabled by digital pathology, providing capabilities across the pharma value chain. Press release.
QIAGEN announced an exclusive strategic partnership with California-based population genomics leader Helix to advance companion diagnostics for hereditary diseases. Under the agreement, QIAGEN will be the exclusive marketing and contracting partner in the U.S. for Helix’s companion diagnostic services. The partnership will leverage the Helix Laboratory Platform, which was granted the first-ever U.S. Food & Drug Administration de novo class II authorization for a whole exome sequencing platform. QIAGEN’s companion diagnostic offerings encompass technologies from next-generation sequencing to polymerase chain reactions (PCR) and digital PCR, sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson’s, including 11 FDA-approved PCR-based companion diagnostics. Press release.