Research & Development
Biocept expands commercial availability of CSF assay to metastatic melanoma
The new CNSide for melanoma assay uses an antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics.
October 17, 2022
FDA approves label expansion for Roche CDx
The label expansion follows the FDA approval in April 2021 of the Ventana MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy Jemperli (dostarlimab-gxly).
August 10, 2022
Nucleix expands EU label for bladder cancer test
Initially, the technology was indicated for the monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.
June 21, 2022
NIH launches molecular typing program of childhood cancers
The service is being conducted through NCI's Childhood Cancer Initiative, which began in 2019. Participants will receive a free molecular characterization of their tumors, including analysis of DNA and RNA taken from tumor and blood samples. The initiative will expand later this year to include soft-tissue carcinomas, the NIH said.
March 20, 2022
Helio publishes study of HelioLiver cancer test
In a prospective phase II study, HelioLiver demonstrated high specificity (91%) and high sensitivity (76%) in detecting early-stage (stage I and II) HCC. In addition, it significantly outperformed other clinically available detection tools such as serum alpha-fetoprotein (AFP) (57%), GALAD (gender, age, Lens culinaris agglutinin-reactive AFP, and des-gamma-carboxy prothrombin [DCP]) scores (65%), and ultrasound (47%) (Hepatology Communications, March 3, 2022).
March 9, 2022
Illumina to collaborate with Japan's National Cancer Center
The study will be part of a trial called the Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing (A-TRAIN). It will include blood samples from up to 96 individuals with nasopharyngeal cancer.
January 23, 2022
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
Viome Life Sciences highlights clinical results
The study was published December 8 in NPJ Genomic Medicine and describes a diagnostic method based on a saliva sample for detecting early-stage oral squamous cell carcinoma. The test received breakthrough device designation in May 2021 from the U.S. Food and Drug Administration (FDA). Lab technology for the test was developed at Los Alamos National Laboratory.
December 19, 2021
Sysmex Inostics touts liquid biopsy findings at ASCO
The featured data will show how the company's SafeSEQ cfHPV-DNA Test (HPV-SEQ) detects cell-free HPV DNA, enabling monitoring for patients with HPV and oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer.
June 3, 2021
Ibex obtains CE Mark for Galen Breast software
Galen Breast uses artificial intelligence (AI) and machine learning and was trained on hundreds of thousands of image samples, scanned from biopsy slides digitized using digital pathology, according to the company.
May 25, 2021
Viome's screening tool given 'breakthrough device' designation
Viome's technology and AI platform is designed to screen for oral cancer and throat cancer, which are traditionally diagnosed manually by a primary care clinician by visual or tactile senses in a subjective way, often going undiscovered.
May 6, 2021
Universal Diagnostics touts blood-based lung cancer test
Presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference, the test uses methylation status measurement of the tumor-derived portion from cell-free DNA (cfDNA) in plasma for patient classification. Researchers examined plasma samples of 37 lung cancer patients and 71 asymptomatic age, gender, and smoking-history matching controls.
January 28, 2021
Researchers get $3.3M to study AI in oral cancer
The U.S. National Cancer Institute awarded the five-year grant to a group led by Anant Madabhushi, PhD, the Donnell Institute Professor of Biomedical Engineering at CWRU and head of the Center for Computational Imaging and Personalized Diagnostics, and Dr. James Lewis Jr., a pathology, microbiology, and immunology professor at Vanderbilt University Medical Center.
January 5, 2021
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