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FoundationOne CDx is a sequencing-based in vitro diagnostic device that can identify alterations in 324 genes from tumour samples. The ROS1 gene is altered in approximately in 1-2% of lung cancer patients. Exposure to environmental factors can cause gene fusion which leads to upregulation of the ROS-1 enzyme.
Alnylam Pharmaceuticals and collaborators have identified rare mutations in the INHBE gene that is expressed in the liver, related to a lower waist-to-hip ratio for body mass index (BMI), which is often used as an indicator of abdominal fat and is correlated with the risk of type 2 diabetes (T2D) and coronary heart disease.
Gene sequencing specialist Illumina has started rolling out a new test that looks for a battery of tumour-associated genes from a single tissue sample, and could be used to help guide treatment for a broad range of cancers. “Comprehensive genomic profiling has proven to be this platform.”
The AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit is the first jointly-developed product that brings together the expertise and reach of Roche with Foundation Medicine’s pioneering leadership in genomic science. Cancer is a disease of the genome and treatment no longer depends solely on the tissue of origin.
In patients with T790M mutant NSCLC receiving osimertinib, 63% experienced loss of T790M at progression, commonly linked to histological transdifferentiation, KRAS mutations, or gene fusions. not reached) in genomic analysis of post-progression samples from patients receiving second-line osimertinib. months vs. 15.2 months, p = 0.01).
From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.
This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care. Advancing Cell and Gene Therapy Cell and gene therapies represent the frontier of medical innovation, offering potential cures for previously untreatable conditions.
FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. FoundationOne Liquid CDx adds to Foundation Medicine’s genomic testing portfolio supporting Roche’s mission to deliver truly personalised healthcare.
In collaboration with clinicians around the world, Casanova’s team studied the genomes of COVID-19 patients, focusing on a set of 13 genes involved in interferon immunity against influenza. percent) of the critically ill patients harbored rare mutations in eight of the genes involved in interferon production. percent of men.
Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. mRNA-based therapeutics and vaccines can be delivered via the below-mentioned approaches.
“However, around the time of the Human Genome Project, there was a ‘land grab’ for the new technologies as big pharmaceuticals tried to catch up paying high prices to access technology platforms in areas such as genomics and high throughput screening.” “Biotechnology has exploded across the industry. .
Molecular diagnostic tests are advanced techniques and tools used to analyze biological markers in the genome and proteome. Molecular diagnostic tests refer to tests intended to detect specific sequences in human genomic samples, such as DNA or RNA, in order to diagnose a particular disease.
Real-time PCR technology allows a rapid and specific measurement of the presence of genes from microorganisms related to infectious diseases, cancer, and genetic abnormalities. Roche is additionally the planet leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
These tumor-derived entities are used to derive genomic and proteomic data. Such information can reveal details about tumor staging, tumor progression, heterogeneity, gene mutations and clonal evolution. In addition, liquid biopsy is a minimally invasive technology and has a much lower risk compared to tissue biopsy procedures.
Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).
Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. Read on to see. COVID-19-Related. Non-COVID-19-Related.
Despite the effectiveness of anti-retroviral therapy (ART) in significantly improving health, quality of life and reducing mortality among HIV-positive individuals, new research shows that persistent infections may be due to the ability of the virus to take refuge in distinct subsets of immune T cells.
New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. About the VIR-7831 Clinical Development Programme.
New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.
He says these issues must be urgently addressed over the next few years as advancing medical knowledge and the role of genomics in treating disease ushers in a new era of precision medicine and new potential to address diseases that affect certain populations. This may sound obvious, but it is still a major hurdle in drug development.
Gene Editing CRISPR-Cas9 and related gene-editing technologies continue to advance, and today they are widely used to study and develop therapeutic approaches for a broad range of human diseases. Related: Biotech IPOs in 2024: Navigating the New Wave of Innovation 1.
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., The draft guidance also describes pre-BLA meeting considerations, noting that FDA strongly recommends scheduling one.
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