PRESS RELEASE 18/03/2025, 07:00 CET
Biocartis Announces Multiple Abstracts
Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be
Presented at USCAP 2025 Annual
Meeting
Mechelen, Belgium, 18 March 2025 –
Biocartis NV (“Biocartis”), an innovative molecular diagnostics
company, is pleased to announce research on the Idylla™ Platform
from several renowned institutions at the upcoming United States
and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting,
taking place from 22-27 March in Boston, MA, US. Seven abstracts
from leading research and academic institutions will be presented
as posters, highlighting the rapid, fully automated molecular
testing capabilities of the Idylla™ Platform across several
different cancer types, including lung cancer1, thyroid cancer2,
endometrial carcinoma3 and colorectal cancer4. Biocartis also
continues to focus on melanoma, blood, brain and breast cancer.
1. From Discard to
Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer
Using Cytology Supernatants
Institution: MD Anderson Cancer Center. To be
presented: Monday 24 March, Stowell-Orbison – Cytopathology -
Poster Board 20
Researchers evaluated the use of the Idylla™
ctKRAS and ctEGFR Mutation Assays on cytology supernatants from
lung cancer patients. The study demonstrated high concordance with
next-generation sequencing (NGS) results, reinforcing the Idylla™
assays as valuable tools for rapid testing of cytology supernatants
that would otherwise be discarded.
2. Racing for Results:
Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration
(FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade
Follicular Cell-Derived Thyroid Carcinoma (HGFCTC)
Institution: Memorial Sloan Kettering Cancer
Center. To be presented: Monday 24 March, Stowell-Orbison –
Cytopathology - Poster Board 31
This study compared the turnaround time and
performance of the Idylla™ BRAF Mutation Assay with
immunohistochemistry (IHC) and NGS in aggressive thyroid
malignancies. The results demonstrated that Idylla™ can provide a
significantly faster and reliable assessment of BRAF status in fine
needle aspiration samples.
3. Detailed Analysis of
MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with
Next Generation Sequencing
Institution: University of California, San
Francisco.To be presented: Monday 24 March, Stowell-Orbison –
Informatics - Poster Board 306
This study utilized MSIsensor2 within an NGS
pipeline to assess MSI status across 100 cases of endometrial
endometrioid carcinoma (EEC). The research analyzed tumor purity,
the impact of mismatch repair (MMR) driver gene mutations, and the
correlation of MSI scores with molecular and clinicopathologic
data. Orthogonal MSI testing was performed by fragment analysis or
Idylla™.
4. Comparison of Two
Automated Real-Time PCR Systems for Cytological Smears in NSCLC:
IDYLLA™ and AmoyDx® Pan Lung Cancer Panel
Institution: Clinica Universidad de Navarra.To be
presented: Monday 24 March, Poster II – Cytopathology - Poster
Board 44
This study compared the Idylla™ System with the
AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological
smears in non-small cell lung cancer (NSCLC). Both systems showed
high concordance with each other and with NGS results, when
available. The Idylla™ System detected additional KRAS mutations
not included in the AmoyDx® Panel, underscoring its broader
detection capabilities. While NGS remained the gold standard, these
automated systems offered faster turnaround times for targeted
treatment decisions.
5. Evaluation of
Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay
in Endometrial and Other CancersInstitution: Icahn School
of Medicine at Mount Sinai.To be presented: Tuesday 25 March,
Poster IV - General Surgical Pathology
This study evaluated the performance of
the Idylla™ MSI Assay in endometrial and other cancers,
revealing strong sensitivity and specificity in colorectal cancer
and highlighting variability in endometrial carcinoma (EC).
Adjustments in threshold settings demonstrated improved concordance
metrics in EC.
6. Assessment of
(Rare) Endometrial Carcinoma with Double Molecular Classifiers
Using Limited Panel Next Generation Sequencing (NGS): Evaluation of
Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of
Concept StudyInstitution: Mayo Clinic.To be presented:
Wednesday 26 March, Poster V - Gynecologic and Obstetric
Pathology
This study assessed a limited NGS panel and its
ability to classify rare double-molecular-classifier cases in
endometrial carcinoma. It incorporated Idylla™ as an orthogonal
CLIA-validated MSI testing method, showcasing its role in resolving
discrepancies in molecular classification.
7. Routine
Implementation of the Idylla™ Fusion Assay: An Assessment of
Performance Based on Prospective Reflex Testing of Non-Small Cell
Lung Carcinoma in a Large Laboratory Setting
Institution: Memorial Sloan Kettering Cancer
Center.To be presented: Wednesday 26 March, Poster V - Pulmonary,
Mediastinal, Pleural, and Peritoneal Pathology
This study evaluated the routine use of
the Idylla™ GeneFusion Assay for detecting fusions in ALK,
ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC.
The Assay demonstrated high sensitivity and specificity, with a
fast turnaround time compared to traditional testing methods.
In addition, Biocartis will showcase the Idylla™
Platform and its innovations in molecular diagnostics at
booth #548, where attendees can learn more about
Idylla™’s ability to deliver actionable, molecular biomarker
results in only 3 hours.
W. Michael Korn, M.D., Chief Medical and
Scientific Officer of Biocartis, commented: “The data
presented at USCAP 2025 underscores the versatility and reliability
of the Idylla™ Platform across a diverse range of oncology
applications. These studies confirm the high concordance between
Idylla™ and next-generation sequencing (NGS) in lung cancer, and
Idylla™’s ability to detect microsatellite instability (MSI)
reliably, demonstrating its clear value in delivering rapid,
actionable molecular insights. The integration of Idylla™ into
real-world laboratory settings, as highlighted in these independent
investigator studies, reinforces its potential to streamline
workflows and reduce turnaround times, ultimately improving patient
management and outcomes.”
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More information:
www.biocartis.com
info@biocartis.com
Biocartis NV. Generaal De Wittelaan 11B, 2800
Mechelen, Belgium
About Biocartis
With its revolutionary and proprietary Idylla™
Platform, Biocartis aspires to enable personalized medicine for
patients around the world through universal access to molecular
testing, by making molecular testing actionable, easy, fast and
suitable for any lab. The Idylla™ Platform is a fully automated
sample-to-result, real-time PCR (Polymerase Chain Reaction) based
system designed to offer in-house molecular biomarker testing in
only 3 hours, allowing fast and optimal treatment selection.
Idylla™'s continuously expanding menu of molecular diagnostic
tests and research assays addresses key unmet clinical needs.
Today, Biocartis offers tests supporting melanoma, colorectal,
lung, breast, thyroid, brain and blood cancer. More
information: www.biocartis.com. Follow us on LinkedIn,
Facebook and X (Twitter).
Disclaimers
The data and conclusions provided in this external
publication were derived externally by third parties and have not
been validated in the development of the Idylla™ Assays or included
in the products' current labelling by Biocartis NV. Biocartis NV
products are designed to be used as described in the
product-specific instructions.
Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays
and Idylla™ GeneFusion & MSI Assays are for Research Use Only
(RUO), not for use in diagnostic procedures. Idylla™ Platform is
CE-marked in Europe in compliance with EU IVD Regulation 2017/746,
listed as a class II device in the US under establishment
registration 3009972873, and registered in many other countries.
Biocartis and Idylla™ are registered trademarks in Europe, the US
and many other countries. The Biocartis and Idylla™ trademarks and
logos are used trademarks owned by Biocartis NV. © March 2025,
Biocartis NV. All rights reserved.
1 Lung cancer remains one of the leading causes of
cancer-related mortality, strongly linked to smoking and
environmental exposures. Advances in biomarker testing have
revolutionized treatment by enabling personalized approaches such
as targeted therapies and immunotherapy. Depending on the stage of
the disease, treatment may involve a combination of surgery,
chemotherapy, radiation, or precision medicine.2 Thyroid Cancer
develops in the thyroid gland, often detected as a painless lump in
the neck. Prognosis is generally favorable, especially when caught
early. Biomarker testing helps assess risk and guide treatment.
Standard therapies include surgery, radioactive iodine, and thyroid
hormone replacement.
3 Endometrial Cancer is a malignancy of the uterine
lining, that most commonly affects postmenopausal women. Biomarker
testing plays a crucial role in assessing prognosis and guiding
treatment decisions. Management typically involves surgery, with
additional therapies such as radiation or hormone treatment
considered based on individual risk factors and molecular
profiling.4 Colorectal Cancer is affecting the colon or rectum,
often linked to lifestyle and genetic factors. Biomarker testing
helps guide treatment decisions, particularly in targeted therapy
and immunotherapy. Testing for these markers can identify patients
who may benefit from specific therapies, such as anti-EGFR or
immune checkpoint inhibitors.
