Press Releases

Clearwater Launches New Enterprise Cyber Risk Management Solution to Help Healthcare Organizations Reduce Cyber Risk, Strengthen Compliance, and Drive Boardroom Confidence

Association for Molecular Pathology Announces 2025 Award Recipients

AMP announced the recipients of its 2025 Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership and Meritorious Service Awards.

Longhorn Vaccines and Diagnostics Partners with Promega to Combine Complementary Offerings for Enhanced Sample Collection, Transport and Analysis

First Blood Test for Endometriosis Launched by Kephera Diagnostics

Kephera Diagnostics announced the launch of EndomTest™, the first non-invasive commercially available diagnostic test for endometriosis in the United States. This test only requires a blood sample.

Clearwater Strengthens Cyber Defense in Healthcare and the Defense Industrial Base with Enhanced Threat Intelligence from Google Cloud

Leica Biosystems Launches ChromoPlex III Detection System to Streamline Chromogenic Multiplex IHC for Reproducible, Digital-Ready Staining

Plug-and-play simplicity meets the demands of modern digital pathology workflows.

Logical Biological Launches Sister Company, Logical Antigen, Delivering Customised Antigen and Protein Purification for IVD Market

Logical Biological announced the launch of a new sister company, Logical Antigen, focused on rapid and customised delivery of high-quality antigens and biologicals, for research and manufacturing of diagnostic products.

Proscia Cements Leadership in Diagnostic Pathology with 400% Growth in Daily Cases

his momentum reflects the company’s strong role as a trusted partner to major laboratories worldwide as it helps them to unlock the clinical, operational, and financial value of AI-driven pathology at scale.

Yourgene Health Launches LightBench Discover

Three-in-one system integrates large fragment analytics, DNA size selection and fluorometric quantification for long-read sequencing

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