See how you can guide the path her cancer takes

Transcription

1 See how you can guide the path her cancer takes

2 The need for improved diagnostics At the advanced edge of oncology, rapid access to accurate data on disease state is vital. Current technologies such as digital PCR and NGS are complex, require a lot of hands-on time and are often difficult to implement in the lab. 1 3 The limitations of these technologies delay the delivery of fast, standardized results, preventing rapid initiation of correct therapy and thereby losing precious time Rapid access to data about relevant cancer mutations and treatment resistance creates the opportunity for disease interception changing the course of a patient s cancer. 4,5

3 The next level in disease interception The Idylla system is the first and only diagnostic system that combines: 1,6 10 Ease of use Fully automated sample processing Speed Short preparation and turnaround time The Idylla system can be used with multiple sample types including liquid (Idylla ctbraf Mutation Assay*) and tissue biopsies (Idylla BRAF Mutation Test). This flexibility allows use of the system for diagnosis and potential future monitoring applications. The Idylla system can simultaneously detect all clinically relevant BRAF V600 mutations, in just one BRAF or ctbraf cartridge. 3,9 The Idylla ctbraf Mutation Assay* is the first of several planned liquid biopsy assays. Accuracy High sensitivity Multiplexing Detection of all relevant mutations in one cartridge Connectivity Remote assistance, monitoring and upgrading *Research use only (RUO), not for use in diagnostic procedures.

4 The power of a fully automated system The Idylla system provides fully automated, high precision PCR: 1,3,7,10 Can be used in any laboratory setting Requires less than 2 minutes hands-on time From sample preparation to result in minutes Allows on-demand access (no need for batching) Doesn t require pre-processing FFPE and plasma samples can be loaded directly into the cartridge Eliminates the risk of PCR contamination (due to the closed nature of PCR cartridges)

5 The fast, straightforward workflow The Idylla system in combination with the Idylla ctbraf Mutation Assay * has the potential to streamline the diagnostic and monitoring process. Comparative workflows Manual interventions 15 MINS 85 MINS Blood draw Sample loading Automated processing & analysis MINS Conventional PCR/ Digital droplet PCR 6 1 DAY BEAMing technology 10 3 DAYS NGS DAYS *Research use only (RUO), not for use in diagnostic procedures.

6 The bright future of liquid biopsy testing Liquid biopsies are less invasive, more cost-effective and provide a more genetically heterogeneous sample of tumour DNA compared to tissue biopsies. 4,5,11,12 Liquid biopsy-based technology has the potential to improve the way disease is intercepted in oncology, allowing you to: 4,5,8,11,13,14 Accurately detect and screen for mutations Continually monitor treatment response Detect treatment resistance early Measure disease burden Detect disease recurrence early How could Idylla help you to change the course of your patients cancer?

7 The accuracy you can rely on Liquid biopsy analysis of BRAF V600 mutation 15 Raw PCR Curves V600E V600K WT The Idylla ctbraf Mutation Assay* shows high sensitivity, detecting down to 60 mutant BRAF V600E copies/ml in a wild-type background (0.06%) Fluorescence Cycles *Research use only (RUO), not for use in diagnostic procedures.

8 The confidence that comes with high concordance Both the Idylla ctbraf Mutation Assay * and the Idylla BRAF Mutation Test are proven to have high concordance with routine PCR diagnostic tests and CLIA-certified methods. 1,8,16 % concordance Idylla ctbraf Mutation Assay (liquid) FFPE CLIA-certified methods (tissue) 88% 100% of concordance with ddpcr and BEAMing in liquid vs. tissue discordant results % concordance Idylla BRAF Mutation Test (tissue) Miseq, Cobas, CLIA-certified methods (tissue) >96% *Research use only (RUO), not for use in diagnostic procedures. Data was obtained with a prototype assay.

9 The innovative approach to cancer monitoring BRAF V600 mutation load as detected by Idylla ctbraf Mutation Assay * 14 BRAF V600 mutation detected in tissue CT scan Partial response % BRAF mutant ctdna CT scan Progressive disease Detection of the BRAF mutant ctdna load in a patient s blood could become a fast, easy and accurate method to see if the patient is responding well to therapy 14 Start BRAF/MEK inhibitor treatment % BRAF mutant ctdna days An increase in BRAF mutant ctdna might give an earlier indication of resistance to therapy compared to CT scan /08/ /09/ /10/ /11/ /12/ /01/ /02/2015 dabra 300mg + trame 2mg dabra 300mg + trame 1mg Figure adapted from Schreuer M et al., *Research use only (RUO), not for use in diagnostic procedures. Data was obtained with a prototype assay.

10 The assessment of overall patient survival 100 Overall survival in patients with BRAF V600 mutation 8 BRAF V600 2% >2% n=160 Measuring the fraction of mutated BRAF ctdna in liquid biopsies to assess overall survival could be another potential application of liquid biopsy Overall survival % Cancer patients with 2% BRAF V600 mutations before start of treatment had a longer overall survival vs. patients with >2% BRAF V600 mutations Time (months) Figure adapted from Janku F et al., 2015.

11 Guide the path their cancer takes The Idylla system can be used with both liquid and tissue biopsies. When used with liquid biopsies, the Idylla system is the first and only fully automated system that combines: 1,6 10 Ease of use Less than 1 minute hands-on time Speed Short preparation and turnaround time Accuracy High sensitivity of 0.06% Multiplexing All relevant BRAF mutations detected in one cartridge Connectivity Remote assistance, monitoring and upgrading The right diagnosis and monitoring system is vital for baseline mutation detection and assessment of future disease monitoring opportunities. With first-time-right results, you can create the opportunity for disease interception changing the course of your patients cancer. Join the investigation of disease interception

12 The future of diagnosis & monitoring Current & future Idylla assays Tissue Liquid Melanoma BRAF ctbraf* ( * ) Lung EGFR** ctegfr** Colorectal KRAS NRAS-BRAF-EGFR S492R* NRAS-BRAF** ctkras** ctnras-braf** MSI** * Research use only (RUO), not for use in diagonostic procedures. ** Idylla ctbraf, NRAS-BRAF, ctkras, ctnras-braf, MSI, EGFR and ctegfr tests are currently under development. Idylla assays are not for sale in the US and Canada.

13 References 1. Janku F et al. Oncotarget. 2015; 6(29): Sam SS et al. Pathol Res Pract pii: jclinpath Colling R et al. J Clin Pathol pii: jclinpath Bratzman SV et al. Expert Rev Mol Diagn. 2015; 15(6): Siravegna G and Bardelli A. Genome Biol. 2014; 15(8): Vandebroucke I et al. Presented at AACR Melchior L et al. Exp Mol Pathol. 2015; 99(3): Janku F et al. Proceedings of the 106th Annual Meeting of the American Association for Cancer Research (#2413), 4/ Jacobs B et al. Poster presented at World CDx Idylla Fully-automated molecular diagnostics system. Product brochure. 11. Gray ES et al. Oncotarget. 2015; 6(39): Janku F et al. Oncotarget. 2015; 6(14): Tsao SC et al. Sci Rep. 2015; 5: Schreuer M et al. Melanoma Res. 2016; 26(2): Biocartis, Data on File. 16. Huang HJ et al. Abstract Presented AACR Annual Meeting DA EN