May 24, 2023 | Trialbee enhances recruitment strategy; Flatiron and Sanofi set out to redesign the clinical trial experience for sponsors, sites, and patients; and Phesi has published the first edition of its Digital Patient Profile (DPP) catalog. Plus: partnerships for Culmination Bio, Cofactor Genomics, Personalis, Ono Pharmaceuticals, National Cancer Center, and more.

Intelligent Medical Objects (IMO), a leading provider of clinical terminology management and data quality solutions for healthcare, has acquired Melax Technologies. Melax Tech empowers the healthcare and life sciences industries through use of Artificial Intelligence (AI) and Natural Language Processing (NLP) technologies to extract information from biomedical textual data to solve real-world problems. The acquisition of Melax Tech will enhance IMO’s portfolio of healthcare data solutions and enable IMO to expand its offerings to various segments in the healthcare market to tackle diverse problems like improving clinical and administrative workflows, clinical research, and patient outcomes. Press release.

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.

Trialbee has enhanced its Omnichannel recruitment strategy by adding features for unprecedented transparency into performance across all channels, sources, and recruitment partners. Available in the Trialbee Honey platform, these vendor-agnostic insights provide powerful real-time ROI data so sponsors can make critical decisions about where to invest and where follow-up is required in order to meet enrollment goals faster. With Honey Omnichannel, customers can: understand the current status, progress, and trajectory of their enrollment milestones; objectively evaluate partner performance including third-party recruitment providers, CROs, patient advocacy groups; and dive deep into the relative value of specific social channels (e.g., Facebook, Instagram, TikTok), digital mediums (email, social, programmatic), and individual campaigns by each referrer in their recruitment ecosystem. Press release.

Culmination Bio and Cofactor Genomics are partnering to leverage samples and data from one of the largest biobanks in the country to fuel the development of Cofactor Genomic’s OncoPrism test in 11 cancers. The objective of the partnership is to build biomarkers for cancers being studied in the national PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) clinical trial. The companies’ relationship is initially focused on studying OncoPrism in cancers of the head, neck, and lung, and will soon expand into nine other indications for which the study is approved, including triple-negative breast, cervical, colorectal, esophageal, gastric, kidney, liver, and urothelial cancers. Early readouts for the head and neck cancer biomarker show that Cofactor’s approach is twice as accurate as the PD-L1 biomarker in finding the subset of patients who respond to immune checkpoint inhibitors. 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.

ArisGlobal has acquired the SPOR (Substances, Products, Organisations and Referentials) data governance and integration solution, SPORIFY. SPORIFY provides consistent and ISO IDMP-compliant SPOR data to feed regulatory activities across the product life cycle, enabling more informed, proactive regulatory decisions to benefit public health and safety. It is the trusted SPOR data harmonization technology solution for five of the world’s top 20 largest pharmaceutical companies and several European regulators. Press release.

Phesi has published the first edition of its Digital Patient Profile (DPP) catalog to deliver granular patient-level data for 28 key disease indications. The profiles, based on 485,000 curated clinical trials and amendments, and data from more than 60 million patients, provide a statistical view of patient attributes for 11 oncology indications and other prevalent diseases including Alzheimer’s, COVID-19, Crohn’s disease and ulcerative colitis. The profiles will be used by sponsors to improve program and trial protocol design and enable the industry to develop Digital Twins and Digital Trial Arms as part of clinical development strategies. DPPs will also support wider adoption of single arm trials by helping sponsors demonstrate efficacy and safety in relevant patient cohorts. Press release.

American Clinical Research Services (“ACRS”), founded in 2022 to improve the quality of life for millions of Americans through scientific research, has acquired Clinical Site Services (“CSSi”) and Patient Advertising Guru (“PAG”). The acquisition of the two previously merged companies demonstrates ACRS’s focus on inclusive patient centric solutions for clinical development. Both Chris Trizna (CSSi) and Evan Brett (PAG) remain as co-Presidents, joining the ACRS leadership team. ACRS is a portfolio company of Latticework Capital Management, a growth oriented private equity firm focused exclusively on the healthcare industry. Press release.

Genialis has released Genialis Expressions version 3.0 to accelerate translational and clinical biomarker discovery. Expressions is a platform for the analysis and management of sequencing data that makes data querying and processing faster, smarter, and more secure. Designed around FAIR data management principles and bioinformatics best practices, the new Expressions delivers leading-edge UX enhancements including 10-100x increased responsiveness. Leveraging microservices via Kubernetes and adaptive AWS resources has improved scalability and cost-effectiveness, allowing users to process hundreds of concurrent transactions with exacting computational resources. The version launch of Expressions follows Genialis’ recent close of $13M Series A financing, announced in March 2023. 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.

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.

Adherence specialists AARDEX Group are proud to announce its partnership with other industry leaders on DiMe’s new Extending the Verification, Analytical Validation, and Clinical Validation (V3+) Framework project. Organizations are taking digital clinical measures and products to scale, meaning digital health technologies (DHTs) must meet the needs of larger audiences. DiMe's existing V3 Framework is the go-to guide for evaluating whether sensor-based DHTs are fit-for-purpose from a technical, scientific, and clinical performance of the product perspective. The goal of the new V3+ project is to build on this success by adding evidence-based components that ensure DHTs meet the needs of all users through the application of best practices in usability, human factors, and human-centered design. Press release.

ObvioHealth, a pioneering virtual research organization (VRO) announces a partnership with A*STAR’s Singapore Institute for Clinical Sciences (SICS) to identify better and more sensitive ways to measure and capture health outcomes. A*STAR’s SICS aims to identify biomarkers and associated treatments that can help populations manage subclinical symptoms more effectively. The first project within this collaboration will be to study subclinical mood disturbances in the general population. The project seeks to identify new digital biomarkers of depressive and anxious feelings, as well as stress, that can be measured and applied in real life settings. Under the agreement, ObvioHealth will provide scientific input into study design as well as access to its ObvioGo platform for the management of participant data. 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.

Flatiron Health has announced a new partnership with Sanofi in their pursuit to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study partnership between Sanofi and Flatiron will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology that digitally transfers data captured in the electronic health record (EHR) directly into the electronic data capture (EDC) system through Flatiron Health’s EHR-to-EDC product, Flatiron Clinical Pipe. Clinical trial sites will be able to reduce time spent on both manual, high-volume data entry and downstream data resolution issues, so that they have more time to spend with patients. By focusing on the area of oncology, this partnership intends to accelerate development of new treatments and help more people with cancer. The collaboration will make it easier for sites to participate in oncology trials by reducing redundant, manual and often error-prone data entry processes, including taxing local lab management. This novel approach will be used across a portfolio of trials and a broad network of research sites – including both Academic and Community cancer centers. Press release.