Press Releases

VieCure Expands Precision Oncology Ecosystem Through Strategic Partnership with Guardant Health

VieCure announced a strategic partnership with Guardant Health to embed Guardant’s next-generation sequencing-based precision oncology tests into the VieCure Halo Intelligence platform.

NIH Awards $1.9M Direct to Phase II Grant to OraLiva for AI-Driven Oral Cancer Diagnostic

I wanted to share a story that may be of interest to 360Dx: our startup OraLiva has just received a $1.9 million NIH/NIDCR Direct to Phase II SBIR grant to advance our AI-driven cancer diagnostic platform for the early detection of oral potentially malignant disorders (OPMDs) using non-invasive brush biopsy samples. The platform, called Onc In-Cyt, is designed to bring scalable, low-cost cancer diagnostics into the dental office by combining point-of-care collection with CLIA lab–based AI cytology analysis. It aims to reduce the cost, delay, and subjectivity of traditional pathology workflows — addressing a major diagnostic blind spot where millions of Americans present annually with lesions that may harbor early-stage cancer. The grant will also accelerate the company’s timeline toward a regulated, widely distributed point-of-care diagnostic device for a series of epithelial cancers (e.g., bladder, cervical, anal, esophageal). The NIH funding will support clinical validation and development of a regulated point-of-care device. You can find the NIH project summary here: https://reporter.nih.gov/search/YKKJhXympkGvSd1LJ2GC0g/project-details/10921587#description I’d be happy to share our press release or set up an interview with our team. Let me know if this could be a fit.

ClearNote Health Receives First In Vitro Diagnostic Approval for its Avantect® Pancreatic Cancer Test

ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received UK Conformity Assessed (UKCA) marking for its Avantect® Pancreatic Cancer Test. The UKCA mark, established as part of the United Kingdom’s independent product safety regulatory framework following its departure from the European Union, signifies compliance with UK medical device regulations and paves the way for commercial availability in the UK market.

Leinco Technologies Strengthens IVD Raw Material Offering Through BioClin Antibody Acquisition

Leinco Technologies has acquired BioClin, Inc.'s essential IVD raw material antibody clones, significantly expanding its catalog, particularly for endocrine hormone research and diagnostic assays. This strategic acquisition enhances Leinco's commitment to providing high-quality, USA-based IVD raw materials to diagnostic manufacturers globally.

Creative Diagnostics Launches Human Hybrid IgM Control Monoclonal Antibodies to Accelerate Diagnostic Assay Development

Creative Diagnostics releases its new Human Hybrid IgM Control Monoclonal Antibodies for research applications.

PHARMASEAL and Viedoc Announce a Technical Integration Partnership

PHARMASEAL, provider of the Engility® Trial Management Platform consisting of a Clinical Trial Management System (CTMS) CTMS and Electronic Trial Master File (eTMF), has announced a Technology Integration Partnership with Viedoc, a global leader in Electronic Data Capture (EDC) and eClinical technologies. This collaboration integrates PHARMASEAL’s advanced CTMS platform with Viedoc’s cutting-edge EDC capabilities, including its flagship product Viedoc Clinic, to deliver a more integrated solution for life science companies managing clinical trials worldwide.

Takara Bio Europe signs distribution agreement with MACHEREY-NAGEL to expand access to high-quality bioanalysis products

Takara Bio Europe is pleased to announce it has entered into a distribution agreement with MACHEREY-NAGEL to expand access to high-quality bioanalysis products.

Baylor Genetics Applauds New Guidance from American Academy of Pediatrics for Genome and Exome Sequencing to be used as First-Tier Tests for Children with Certain Developmental Delays

Baylor Genetics, a leading clinical diagnostic laboratory at the forefront of genetic testing, today announced its support for the American Academy of Pediatrics’ (AAP) updated guidance recommending whole genome and whole exome sequencing as first-tier tests. Baylor Genetics has long recognized the value of these tests, and offers a comprehensive, structured framework to help pediatricians promptly identify potential genetic causes in children presenting with global developmental delay (GDD) or intellectual disability (ID). This milestone empowers pediatricians, supported by genetics professionals, with access to earlier and more comprehensive insights that guide clinical decisions for patients and their families, marking a critical step toward faster diagnoses and improved outcomes.

Alithea Genomics Announces the Launch of MERCURIUS™ FLASH-seq: A Plate-Based, Full-Length Single Cell RNA-seq Kit Delivering Exceptional Sensitivity and Simplicity

Alithea Genomics has announced the commercial launch of MERCURIUS™ FLASH-seq, a next-generation library preparation kit for full-length single-cell RNA sequencing.

Association for Molecular Pathology Publishes Best Practice Recommendations for Clinical HRD Testing

AMP recently published a new report with 12 best practice recommendations focused on the design and validation of clinical HRD assays. To develop these recommendations, AMP assembled an expert panel that included organizational representation from ACCC, ASCO, and the CAP.

Ambience Healthcare's "Patient Recap" Offers Clinicians the First Chart Summarization Technology from an Ambient AI Platform

Phastar appoints Industry Veteran Billy Amzal as Head of Strategic Consulting

Phastar, a global specialist biometrics & data science Contract Research Organization (CRO), today announced the appointment of Billy Amzal as Head of Strategic Consulting.

New Collaboration Initiative: Alfa Chemistry Announces Inclusion as a Listed Supplier across CHEMnetBASE Dictionaries

To make it easier for researchers to find and access the specialized chemicals they need, Alfa Chemistry has announced that it has been added as a supplier to the CHEMnetBASE dictionaries, the world’s premier collection of interactive chemistry databases from CRC Press, Taylor & Francis Group. This means that Alfa Chemistry’s vast catalog of specialized chemicals will be easily discoverable within the premier digital chemistry resource used by researchers and scientists around the world.

Alithea Genomics Launches MERCURIUS™ Total DRUG-seq: A Next-Generation Full-Length Transcriptome Profiling Platform for High-Throughput Compound Screening and Target Validation

Alithea Genomics has announced the launch of MERCURIUS™ Total DRUG-seq to push the boundaries of high-throughput drug screens, toxicology screens and target validation.

PackworldUSA Highlights the Versatile and Precision-Driven 3400 Series Heat Sealer for Medical Device Packaging

PackworldUSA highlights the launch of its advanced 3400 Series Heat Sealer, designed specifically for industries requiring high-precision packaging solutions. For medical applications, this system offers unmatched versatility, cleanroom compatibility, and ease of use.

One2Treat, the leading company incorporating the patient voice into clinical development, launches One2Treat Voice app

One2Treat SA, a fast-growing tech company incorporating the patient voice in all strategic decisions about treatment assessments in Pharma R&D, today announced the launch of the One2Treat Voice app, a new module of their software platform.

Astoriom Appoints Brittany Jackson as CFO

Key appointment to lead the company’s financial strategy and support continued global growth in sample stability and biorepository storage solutions

ClearNote Health Avantect® Pancreatic Cancer Test Enters Patient Enrollment Phase of Groundbreaking UK Study Targeting High-Risk Patients

ClearNote Health announced initiation of patient enrollment for a new study that aims to advance early detection of pancreatic cancer in individuals newly diagnosed with type 2 diabetes.

Majority of Diagnostic Laboratory Leaders Bet Big on Digital Pathology and AI

Survey of 360 senior professionals finds modernization is key to overcoming longstanding industry challenges.

Echosens and Boehringer Ingelheim Expand Long-Standing Collaboration to Accelerate Progress in MASH Diagnosis and Care

Echosens and Boehringer Ingelheim have expanded their long-standing partnership to accelerate progress in MASH diagnosis and care.