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Clinical Assay Articles & Analysis

32 news found

ECP Posters spotlight

ECP Posters spotlight

In this piece, we talked to the two presenters of the poster “The Validation of a Homologous Recombination Deficiency Assay into Clinical Practice within the NHS”, Elizabeth Ratsma, Pre-Registration Clinical Scientist – Cancer Genomics and Charlotte Flanagan, PhD, Innovation Lead, from The Royal Marsden NHS Foundation Trust. ...

BySOPHiA Genetics


SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

Together, SOPHiA GENETICS and Boundless Bio pioneered the ecDNA Solution (ECS) algorithm to detect the presence of ecDNA using routine clinical next-generation sequencing (NGS) data. ECS is the first ecDNA clinical trial assay and was designed by SOPHiA GENETICS in alignment with FDA guidelines as an Investigational Use Only ...

BySOPHiA Genetics


The US Patent Office Grants BIOMARK Additional Patent for its LIQUID BIOPSY Technology

The US Patent Office Grants BIOMARK Additional Patent for its LIQUID BIOPSY Technology

BioMark is currently pursuing two clinical trials using this liquid biopsy platform that can improve identification and assessing response to treatment for patients with lung cancer and glioblastoma. ...

ByBioMark Diagnostics Inc.


BillionToOne launches oncology liquid biopsy products for research use & announces clinical research collaboration with UCSD

BillionToOne launches oncology liquid biopsy products for research use & announces clinical research collaboration with UCSD

Northstar Response is a methylation-based, tissue-agnostic treatment response monitoring assay. Using our molecular counting technology, the assay provides absolute quantification of methylated circulating tumor DNA (ctDNA) burden. The purpose of the assay, when it becomes clinically available in Q1 2023, will be to enable ...

ByBillionToOne Inc.


Seres Therapeutics Presents Microbiome Therapeutic Research at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Seres Therapeutics Presents Microbiome Therapeutic Research at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

“This microbial consortium builds on our scientific and clinical data, and we are encouraged by these preclinical results that suggest potential areas of investigation and future development opportunities for this new area of ...

BySeres Therapeutics, Inc.


Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting

Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting

About SER-155 SER-155, an oral consortium of cultivated bacteria, is a microbiome therapeutic candidate in clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models, with the aim to decrease infection and translocation of antibiotic-resistant bacteria ...

BySeres Therapeutics, Inc.


Guardant Health Announces Shield™ Blood Test Available in US to Detect Early Signs of Colorectal Cancer in Average-Risk Adults

Guardant Health Announces Shield™ Blood Test Available in US to Detect Early Signs of Colorectal Cancer in Average-Risk Adults

Barriers associated with currently available methods, such as a colonoscopy or a stool-based test, can make the process unpleasant, time-consuming and difficult to complete.2 With a simple blood draw, the Shield test overcomes these barriers because it requires no special preparation, no sedation, no dietary changes, no extra time away from family or work, and it can be completed as part of any ...

ByGuardant Health, Inc.


Carina Biotech to showcase its LGR5 CAR-T program at the American Association for Cancer Research (AACR) Annual Meeting

Carina Biotech to showcase its LGR5 CAR-T program at the American Association for Cancer Research (AACR) Annual Meeting

Highlights Five conference abstracts will be presented as poster presentations at AACR in the immuno-oncology and preclinical immunotherapy sessions Four presentations describe preclinical data from Carina’s LGR5-targeted CAR-T cell program, one poster will describe preclinical data from Carina’s ADAM-10 CAR-T program With its LGR5 CAR-T, Carina is progressing towards a ...

ByCarina Biotech


Agplus Appoints New Chief Scientific Officer

Agplus Appoints New Chief Scientific Officer

Ahead of their attendance at this year’s MEDICA event, AgPlus have appointed a new Chief Scientific Officer, Dr Nic Christofides, who has vast experience of finalising late stage clinical assays to ensure commercial success. Of Cypriot descent, Dr Christofides started his career in 1973 at Hammersmith Hospital, London, as a research assistant where he ...

ByAgPlus Diagnostics Ltd


New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth

New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth

As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD) system from Thermo Fisher Scientific will enable them to expand their assay menus and IVD testing capabilities moving forward. ...

ByThermo Fisher Scientific


Optimizing and Accelerating COVID-19 Predictive Modeling

Optimizing and Accelerating COVID-19 Predictive Modeling

Several new features that may be implicated in clinical pathways, including viral mRNA translation pathway, interferon-gamma signaling, and Innate Immune System, also emerged. ...

ByJADBio


Appointment Michelle Meijer as Chief Commercial Officer

Appointment Michelle Meijer as Chief Commercial Officer

She held several senior business development and management roles at Roche Diagnostics and QIAGEN, around the years that The Netherlands was preparing for primary HPV screening and the industry was developing clinically validated assays to support this new era. It was also then that she collaborated with the scientists who carry decades of dedication to improve ...

BySelf-screen B.V.


Eurogin QIAGEN symposium

Eurogin QIAGEN symposium

During the QIAGEN symposium at Eurogin the latest clinical performance and study data around Self-screen’s molecular screening and triage solutions were presented by excellent scientists. ...

BySelf-screen B.V.


SEngine Precision Medicine Presents Data at 2021 AACR Annual Meeting Demonstrating Clinical Utility and Predictive Value of PARIS Test in Ovarian Cancer

SEngine Precision Medicine Presents Data at 2021 AACR Annual Meeting Demonstrating Clinical Utility and Predictive Value of PARIS Test in Ovarian Cancer

The poster presentation highlighted the utility of the PARIS® Test, a CLIA certified functional drug sensitivity assay, to support clinical decision making in ovarian cancer. In an ovarian cancer cohort of 44 evaluable patient samples, authors found that: Ovarian cancer patient-derived 3D cultures preserve the histopathological and molecular features of ...

BySEngine Precision Medicine


Review our webinar: Clinical Validation of HPV assays on the NeuMoDx Platform

Review our webinar: Clinical Validation of HPV assays on the NeuMoDx Platform

Bart Hesselink talks about the clinical validation of QIAGEN’s next generation HPV screening assay on the NeuMoDxTM Molecular Systems. ...

BySelf-screen B.V.


Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use

Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use

The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows. Clinical diagnostic and hospital laboratories across the United States have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


The Netherlands started QIAsure Methylation Test implementation trial for triage of HPV positively screened women

The Netherlands started QIAsure Methylation Test implementation trial for triage of HPV positively screened women

More women at risk are being discovered due to the higher sensitivity of HPV assays compared to the old cytology based test program, but as a consequence the number of referrals after cytology based triage of HPV positive women has increased 3 times. ...

BySelf-screen B.V.


Cytovale Receives Distinguished Abstract Award from AACC for Evaluation of Sepsis Assay

Cytovale Receives Distinguished Abstract Award from AACC for Evaluation of Sepsis Assay

Currently, no rapid diagnostics exist with clinically actionable performance for early sepsis diagnosis in acute care environments, leaving ED clinicians to balance the benefits of early intervention against the risks of unnecessary and resource-intensive interventions. ...

ByCytovale Inc.


SEngine Precision Medicine Presents Data Summarizing Predictive Value of PARIS Test in Breast Cancer Patients at 2020 San Antonio Breast Cancer Symposium

SEngine Precision Medicine Presents Data Summarizing Predictive Value of PARIS Test in Breast Cancer Patients at 2020 San Antonio Breast Cancer Symposium

This study highlighted the utility of the PARIS® Test, a CLIA certified functional drug sensitivity assay, to support clinical decision making in heterogeneous disease such as breast cancer. Authors found that the PARIS® Test: Showed a high success rate (70.5%) in delivering a report ranking targeted, endocrine and chemotherapy agents in a ...

BySEngine Precision Medicine


StemBioSys and Cartox Announce Publication of Research Demonstrating CELLvo™ Matrix Plus Significantly Enhances the Functionality of hiPSC Cardiomyocytes

StemBioSys and Cartox Announce Publication of Research Demonstrating CELLvo™ Matrix Plus Significantly Enhances the Functionality of hiPSC Cardiomyocytes

Lastly, and importantly, Matrix Plus enabled high throughput cardiotoxicity screening using mature human cardiomyocytes with validation utilizing reference compounds recommended for the evolving Comprehensive In Vitro Proarrhythmia Assay (CiPA) coordinated by the Health and Environmental Sciences Institute (HESI). ...

ByStemBioSys, Inc.

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