PRESS RELEASE: 16 November 2020,
Biocartis Announces Ten Idylla™ Studies to be Published at Virtual AMP (US) Annual Meeting
The published oncology studies include the Idylla™ MSI, EGFR, ctEGFR, KRAS and ctKRAS Mutation Assays:
- The
Memorial Sloan Kettering Cancer Center (New York , US) study2 evaluated the performance of the Idylla™ MSI Assay across different tumor types (pan-cancer) including endometrial, colorectal, prostate, small bowel and breast cancer. Data presented showed equivalency to Immunohistochemistry (IHC)3 and a greater sensitivity compared to MSK-IMPACT™, a Next Generation Sequencing (NGS) test, where the Idylla™ MSI Assay provided definitive results for numerous indeterminate cases. - The
University of Alabama at Birmingham (Birmingham, Alabama , US) study4 showed 100% agreement between the Idylla™ MSI Assay and IHC using prostatectomy specimens and describes the Idylla™ MSI Assay as a reliable option for MSI testing in high-grade prostate cancer. - The
Dartmouth-Hitchcock Medical Center (New Hampshire , US) study5 showed the feasibility of the Idylla™ MSI Assay to identify Lynch Syndrome6 using colorectal adenomas. - Two
Massachusetts General Hospital (Boston, Massachusetts , US) studies showed how rapid testing with Idylla™ can complement comprehensive PCR/NGS7 workflows, based on testing with the Idylla™ EGFR Mutation Assay and the Idylla™ ctKRAS Mutation Assay. Both studies show a reduction of the turnaround time with Idylla™ testing by approximately 50% or more, next to its ease of use and usefulness to provide for results when NGS fails8. - Another
University of Alabama at Birmingham (Birmingham, Alabama , US) study9 evaluated the performance of the Idylla™ KRAS Mutation Assay using de-stained cytology smears of lung non-small cell carcinoma (NSCLC) cases as an alternative source to rescue limited quantity samples. Comparison with previous NGS results showed 100% concordance. - The
Dartmouth-Hitchcock Medical Center (New Hampshire , US) study10 evaluated the Idylla™ ctEGFR Mutation Assay on samples with DNA concentrations insufficient for NGS. Results showed a majority of samples successfully tested at a concentration of less than 40 ng DNA.
In addition, three studies discuss new
- The
Dartmouth-Hitchcock Medical Center (New Hampshire , US) study11 evaluated the Idylla™ SARS-CoV-2 Assay showing 100% concordance with their reference method. - Biocartis’ partner
Immunexpress will present two abstracts12 demonstrating that the new SeptiCyte® RAPID on Idylla™ correlates strongly with Immunexpress’ existing SeptiCyte® LAB test, is reproducible, and can be used not only to differentiate patients with bacterial and viral, but also candida sepsis13 from clinical controls.
Abstracts of the studies are published in the
Herman Verrelst, Chief Executive Officer of
--- END ---
More information:
Head of
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
About
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
1 All studies were performed with Idylla™ RUO assays, research use only, not for use in diagnostic procedures
2 ST41. Rapid Assessment of Microsatellite Instability across a Spectrum of Tumor Types Using the Idylla System, Momeni-Boroujeni1, M. Arcila2, D. Ferguson2, U. Patel2, R. Chan2, J. Barbee2, A. Zehir2, J. Hechtman2, M. Ladanyi2, K. Nafa2 1Brigham and
3 Immunohistochemistry is a laboratory method that uses antibodies to check for certain antigens (markers) in a sample of tissue. It’s used to help diagnose diseases, such as cancer. It may also be used to help tell the difference between different types of cancer. Source: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immunohistochemistry, last consulted on
4 ST06. Assessment of Microsatellite Instability on a Multi-Racial Cohort of High Grade Prostate Cancer Using Idylla MSI Test,
5 ST60. Microsatellite Instability Testing for Lynch Syndrome Screening in Colorectal Adenomas, Javanbakht,
6 Lynch Syndrome, also known as hereditary non-polyposis colorectal cancer (HNPCC), is a type of inherited cancer syndrome associated with a genetic predisposition to different cancer types. This means people with Lynch syndrome have a higher risk of certain types of cancer. Source: cancer.net, last consulted in
7 PCR = Polymerase Chain Reaction. NGS = Next Generation Sequencing
8 The first study (ST40. Rapid qPCR Testing in the NGS Era Enables Same-Day Resulting of EGFR Mutant NSCLC,
9 ST08. De-stained Cytology Smears Can Be Used for Detection of KRAS Mutations Using the Biocartis Idylla PCR-Based Molecular Diagnostic Assay,
10 TT25. Evaluation of the Biocartis Idylla ctEGFR Mutation Assay on Samples with DNA Concentrations Insufficient for Next-Generation Sequencing (NGS),
11 ID42. Evaluation of a Sample-to-Answer Cartridge-Based SARS-CoV-2 Assay,
12 ID02. Comparison of a Cartridge-Based Host Gene Expression Test to a
13 In addition to bacteria, fungi—mainly Candida albicans and other Candida spp. —can cause sepsis and this entity has increased over the last decades, now causing significant impact and health care-associated costs. In addition, fungal sepsis is associated with a higher mortality than bacterial sepsis. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4601378/, last consulted on
© OMX, source