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Biocartis US, Idylla (Molecular, 2018)

Biocartis US, Idylla (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

Biocartis US
Vishal Sikri
customerserviceUS@biocartis.com
Jersey City, NJ
844-4-IDYLLA (844-443-9552)


Name of instrument Idylla
Country where designed/Manufactured/Reagents manufactured Belgium/Belgium/Belgium
Instrument FDA cleared or approved/Platform yes/preanalytical and analytical
First year sold in U.S./Sold internationally/Installed 2017/2014/2014
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 12 × 7.5 × 19.9/1.036 instrument + 0.694 console/max. 54
Supplied with UPS/BTU no/—
Physical contamination control features closed, sealed cartridge
List price/Price for sample extraction and amplification detection modules $49,000/—
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/1 tissue slide; 1 mL of plasma
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/100–240 V
Labor and parts warranties/Advanced operator training 1 year/no
Delivery time/Delivery charges/Installer/Time to install on site immediate/shipping costs (destination)/Biocartis US/2 hrs.
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on site/5/2 hrs./no
Test menu EGFR, MSI, KRAS, NRAS, NRAS-BRAF, BRAF, ctKRAS, ctNRAS-BRAF, ctBRAF
No. of tests for which analyzer has FDA-cleared applications/CE mark 0/7
Tests available on instrument in U.S./Outside U.S. EGFR, MSI, KRAS, NRAS-BRAF, BRAF, ctKRAS, ctNRAS-BRAF, ctBRAF/EGFR, MSI, KRAS, NRAS, NRAS-BRAF, BRAF, ctKRAS, ctNRAS-BRAF, ctBRAF
Tests not available in U.S. but submitted to FDA/Available in other countries only 1/—
Research-use-only assays/Tests in development EGFR, MSI, KRAS, NRAS-BRAF, BRAF, ctKRAS, ctNRAS-BRAF, ctBRAF/ctEGFR
Open-channel capabilities/Start-up and preparation time no/<2 min.
Model type of sample-handling system/Maximum sample load capacity —/cartridge-based system with 1 sample per cartridge
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 1 tissue slide, 1 mL of plasma/yes/—
Minimum dead volume/Pediatric sample volume/Primary tube sampling —/—/no
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D —/yes/yes
Sample barcode languages/Sample types available in open mode various/—
Clot detection/Open extraction platform/Sample types (open extraction) no/no/—
Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once 1/1
Tests per container set/Multiple reagent configurations supported
Reagent container placed directly on system/Onboard test auto inventory yes/no
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes
Monitors expiration date/Auto lot recognition or calibration yes/yes
Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry
Reagent reconstitution required/Chemical contamination control no/—
Onboard test auto inventory/Capable of inventory monitoring by barcode no/no
System is open to homebrew/General-purpose reagents allowed no/no
Same capabilities when third-party reagent used/Lot sequestering available no/no
Closed-vial stability for amplification reagents/Extraction reagents >1 year/>1 year
Storage temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Shipment temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Minimum/Maximum reagent shelf-life guarantee >12 months/>12 months
Autocalibration or autocalibration alert/Multipoint calibration supported yes/yes
Assay calibrations required by end user/Calibrants can be stored onboard no/yes
Multiple calibrant lots stored for same assay/Required calibration frequency yes/built into run
Length of assay calibration/Typical calibration frequency built into run/built into run
Onboard real-time QC/Supports multiple QC lot numbers per assay yes/no
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC yes/<5 min./yes
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests
Walkaway capacity/Tech hands-on time (both for batch of 96 samples)
Uses disposable pipette tips/Maximum number of pipette tips stored no/—
Time between start and initial result/Instrument automatic shutdown BRAF: minimum 90 min.; EGFR: maximum 150 min./yes
Startup programmable/Remote system monitoring/Waste required for disposables no/yes/according to laboratory procedures
Windows technology/Mouse or touchscreen/Modular add-on capability yes/touchscreen/yes
Service contracts available/Mean time between failures/To repair failures yearly/>18 months/depot replacement model 1–3 days
Turnaround time for problem solving by phone/Email/Field service 1 day/1 day/3 days
No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/—/8 hrs., 5 days
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions 1 business day/yes/yes
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/yes
Average maintenance time for lab personnel/Onboard maintenance records monthly: <1 min.; yearly: 10 min./no
Preventive maintenance per year for sample extraction/Amplification detection yes/—
Downtime for preventive maintenance/Spare parts on site 2 hrs./no
Software and LIS interface:
• Patient demographics and insurance data available via rules-based architecture no
• Data retrieval or Internet connectivity yes
• Online real-time help, QC, stats, and management reports/Evaluates results validity yes/yes
• Priority processing yes
• Supports accession No. redundancy/Specimen carrier and level identification
• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions no/no/yes
• Sample storage and retrieval software supports CLSI standards yes
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/—
• QC results transferred automatically to LIS/Data-management capability
• Interfaces operational in active user sites
• Rules-based control subsystem/Process control via control subsystem
• LIS operates simultaneously with assays running yes
• Uses LOINC to transmit orders and results/Unidirectional interface capability yes/—
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/no
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs yes/—/yes
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) fully automated sample-in/result-out molecular system; accurate results in minutes, not days; versatile sample type: FFPE tissue or plasma; hands-on time of < 2 min. for tissue or plasma; extensive menu for oncology; low running costs
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.