Liquid Biopsy Applications on the Idylla Fully Integrated Sample-to-Result MDx System Erwin Sablon, Head of R&D, Biocartis NV World CDx, Boston, September 10 th 2015 0
About Biocartis Innovative molecular diagnostics (MDx) company providing highly automated instruments in combination with novel and broadly applicable molecular diagnostic tests Founded in 2007 by Dr. Rudi Pauwels in Lausanne, Switzerland Headquartered in Mechelen (BE), employ approximately 200 people Euronext listed since April 2015 ( BCART ) Our products: MDx system Idylla and test development in Oncology and Infectious Diseases * The Idylla MDx System is currently not available in the USA and Canada. The Idylla Platform is a CE marked IVD 1
The Idylla TM System Console Instrument Cartridge * The Idylla MDx System is currently not available in the USA and Canada. The Idylla Platform is a CE marked IVD 2
Fully automated sample-to-result platform offering unsurpassed ease of use and fast time to result SCAN SAMPLE SCAN CARTRIDGE LOAD SAMPLE INSERT CARTRIDGE 35 to 150 minutes 3
Relevance Any clinical sample type: vast range of applications Idylla is equipped with powerful sample preparation functionalities enabling it to process a wide diversity of primary clinical sample types Versatile detection of multiple biomarkers per sample (up to 30 targets in standard mode) BLOOD/ PLASMA/ SERUM SWAB URINE SPUTUM STOOL FFPE FINE NEEDLE ASPIRATE Viral load tests Sepsis Liquid biopsies Infectious disease tests Genetic tests STDs Urogenital cancers Liquid biopsies Respiratory tract infections Gastrointestinal tract infections Standard sample type for tumor biopsies Lung biopsies Spinal fluid (meningitis) 4
Idylla research cfdna assays: fully automated sample-to-result Idylla is a Sample-to-result platform with a single instrument and without requiring any manual sample pre-treatment Cartridge fully enclosed no PCR lab infrastructure required All reagents placed on-board cartridge during manufacturing; cartridge stable at room temperature, no cold chain required 1ml of EDTA plasma cfdna solubilization DNA/RNA extraction Amplification/ detection Data analysis * The Idylla MDx System and tests are currently not available in the USA and Canada. The cfdna assays are currently research prototypes 5
cfbraf concordance between plasma and FFPE tumor samples Concordance between FFPE and plasma was 88% (141/160) for plasma samples collected before therapy. BRAF V600 mutations were detected in the FFPE tumor tissue but not in cfdna in 17 patients (melanoma, 7; colorectal cancer, 3; thyroid cancer, 3; ovarian cancer, 2; NSCLC, 1; glioblastoma, 1) BRAF V600 mutation testing of plasma cfdna with ddpcr demonstrated 100% concordance with Idylla prototype assays. Additional discordance testing of plasma cfdna (15/19) with BEAMing demonstrated 100% concordance with Idylla prototype assays. Janku F. et al., AACR annual meeting 2015 Idylla prototype assays are able to identify BRAF mutations with a sensitivity down to 0.05% 6
cfbraf prototype assay Sensitivity example Sample 1 Plasma: BRAF Wild type Sample 2: Plasma: 50% V600E Sample 3: Plasma: 0.05% V600E Solid tumor status: V600 wt Solid tumor status: V600E Solid tumor status: V600E 7
Liquid biopsy Applications on the Idylla System Biocartis' Idylla chemistries and protocols allow for the required levels of sensitivity to pick up small circulating free DNA fragments in plasma Initial results for the prototype cfbraf Plasma Mutation Test: 88% concordance with tissue-based testing 100% concordance with the most sensitive method available for plasma testing ("BEAMing") Idylla solid biomarker panels to be followed by liquid biopsy panels: BRAF FFPE (CE-IVD) KRAS FFPE (CE-IVD) NRAS FFPE (In late development) * The Idylla MDx System and tests are currently not available in the USA and Canada. The cfdna assays are currently research prototypes 8
Biocartis and Abbott Molecular: Combining Strengths through Partnership Platform Global Commercial Footprint Commercial Scale Manufacturing Pharma Network 9