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Idylla™ GeneFusion Assay will be released for Research Use Only, not for use in diagnostic procedures. Characteristics are subject to change.
LAUNCHING SOON!
IDY LAL
CLOSING THE GAPIDYLLA™GENEFUSION ASSAY
FULLY-AUTOMATED walk-away systemNo need for specialized molecular expertise
RELEVANT BIOMARKERS ACROSS MULTIPLE CANCER TYPES covering all genes for which fusion testing is recommended
INTRODUCING IDYLLA™GENEFUSION ASSAY FORSPEED AND SIMPLICITY
M I N I M U M S P E CI M E N R E Q U I R E M E NT S
• If ≥20mm² tissue area: 1 x 5µm FFPE tissue section
• If <20mm² tissue area: 3 x 5µm FFPE tissue sections
• ≥ 10% neoplastic cell content
ALK, ROS1, RET, NTRK1/2/3
fusions & MET Exon 14 skipping
in one cartridge
Directly from 1-3 FFPE slices
Fully automated molecular testing platform
On-demand testing
Less than 2 minutes hands-on time
Assay turnaround time of approx. 180 minutes
A unique combination of 2 detection technologies:
Highly sensitive detection of the most gene fusions directly from RNA transcripts
by real-time PCR (RT-qPCR).
Expression imbalance detecting gene fusions irrespective of fusion partner based
on the 3’ kinase overexpression caused by the partner gene.
IDYLLA™ GENEFUSION ASSAY DETECTION OF KNOWN AND NOVEL FUSIONS
THE RIGHT SOLUTION FOR ANY LAB
Idylla™ GeneFusion Assay will be released for Research Use Only, not for use in diagnostic procedures.
FAST, EASY AND OBJECTIVEThe Idylla™ GeneFusion Assay consolidates traditional testing workflows into one streamlined,
fully-automated process providing reliable, objective information on ALK, ROS1, RET, METex14
skipping and NTRK1/2/3 in about 180 minutes.
ONLY LIMITED AMOUNT OF SAMPLE NEEDEDThe Idylla™ GeneFusion Assay provides simultaneous detection of strategic biomarkers
on-demand from a minimum of sample thereby saving valuable samples.
FIRST LINE ACTIONABLE INFORMATIONThe Idylla™ GeneFusion Assay provides an ultra-rapid actionable solution which can be seamlessly
integrated into virtually any laboratory workflow complementing comprehensive NGS.
Detection Method
Specific fusion detection • • • • - - -
Coverage in NSCLC 93% 97% 85% - - - -
Expression imbalance • • • - • • •
IDYLLA™ GENEFUSION ASSAY SHOWING EXCELLENT PRELIMINARY DATA1
(1) Idylla™ call is result of preliminary decision tree algorithm. The study was performed with prototype cartridges on NSCLC FFPE samples except for NTRK1/2/3 where also other cancer type samples were used.
IDYLLA™ VERSUS NEXT GENERATION SEQUENCING
Idylla™ vs Archer® FusionPlex®
Overall concordance 99% 97% 100% 99% 100%
PPA 94% 100% 100% 100% 100%
NPA 100% 97% 100% 98% 100%
Idylla™ vs Oncomine™ Focus
Overall concordance 99% 100% 100% 100% 99%
PPA 100% 100% 100% 100% 100%
NPA 99% 100% 100% 100% 99%
IDYLLA™ VERSUS IMMUNOHISTOCHEMISTRY
Idylla™ versus Ventana® ALK D5F3
Overall concordance 100%
PPA 100%
NPA 100%
Samples were tested for ALK and Idylla™ GeneFusion Assay detected positives in 14/95 for ALK.
Samples were tested for ALK, ROS1, RET, METex14 and NTRK1/2/3 and Idylla™ GeneFusion Assay detected
positives in 15/78 for ALK, 1/82 for ROS1, 4/82 for RET, 5/72 for METex14 and in 4/87 for NTRK1/2/3.
Samples were tested for ALK, ROS1, RET, METex14, NTRK1/2/3 and Idylla™ GeneFusion Assay
detected positives in 17/98 for ALK, 3/98 for ROS1, 3/98 for RET, 8/98 for METex14 and in
3/104 for NTRK1/2/3.
GENE FUSION FACTS
Gene fusions represent an important class of somatic alterations in cancer. Due to their
inherent expression in tumor tissue alone they have become important biomarkers for
cancer diagnosis, prognosis, and targeted therapies.1,2,3
Discovery and further understanding of fusion genes across multiple cancer types may
provide more effective therapies in the future for cancer patients.
Over the last 20 years, many gene fusions have been discovered in hematological
cancers, solid tumors, and sarcomas.
(1) Stransky et al. The landscape of kinase fusions in cancer. Nat Commun. 5, 4846, 2014.(2) Schram et al. Fusions in solid tumours - diagnostic strategies, targeted therapy, and acquired resistance. Nat Rev Clin. Oncol. 14 (12), 735-748, 2017.(3) Mertens et al. The emerging complexity of gene fusions in cancer. Nat Rev Cancer 15, 371-381, 2015.
PEDIATRIC ADULT
SALIVARY GLAND CANCER
THYROID CANCER
HEPATIC CANCER
LUNG CANCER
GI CANCER
CNS CANCER
SARCOMA
MELANOMA
SARCOMA
SECRETORY BREAST CANCER
RENAL CANCER
CNS CANCER
Biocartis NVGeneraal de Wittelaan 11B2800 Mechelen - Belgium+32 15 632 [email protected]
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(1) Comparison results noted from studies using early prototypes including a preliminary decision tree algorithm. Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, Patent applications US 14/483,804, 13/616,107, 15/898,275, 15/973,718, 16/687,763, 12/738,524, 14/503,525, 15/364,870, 13/204,342, 10,551,383, 16/729,736, 13/699,309, 15/616,111, 15/994,165, 14/394,793, and their respective foreign equivalents under license from Cell Signaling Technology, Inc. The Idylla™ GeneFusion Assay uses SuperScript™ III. The SuperScript III trademark is owned by Life Technologies Corporation. Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis trademark and logo and the Idylla trademark and logo are used trademarks owned by Biocartis. Idylla™ platform is CE-marked IVD in Europe. Idylla™ GeneFusion Assay is currently under development. Idylla™ GeneFusion Assay will be released for Research Use Only (RUO), not for use in diagnostic procedures. Characteristics are subject to change. Idylla™ is available for sale in EU, USA and some other countries. Please check availability with the local Biocartis sales representative. © Biocartis, January 2021 G
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Catalog number: A0121/6
IDYLLA™ GENEFUSION ASSAY FOR SPEED AND SIMPLICITY BECAUSE TIME MATTERS
SARCOMA
SECRETORY BREAST CANCER
RENAL CANCER
CNS CANCER
Information on ALK, ROS1, RET, METex14 and NTRK1/2/3 inONE SINGLE CARTRIDGE
Excellent preliminaryCONCORDANCE results1
versus IHC, Archer®and Oncomine™
ON-DEMAND testing
LIMITED amount of SAMPLE INPUT
needed
ULTRA-RAPID TAT < 180 min HOT < 2 min
FULLY-AUTOMATED walk-away systemNo need for specialized molecular expertise
RELEVANT BIOMARKERS ACROSS MULTIPLE CANCER TYPES covering all genes for which fusion testing is recommended
