Biocartis US, Inc.
Biocartis is an innovative molecular diagnostics company committed to revolutionizing molecular testing with its proprietary Idylla™ Platform. The company focuses on providing next-generation diagnostic solutions to improve clinical practice, especially in oncology, supporting various cancer types including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer. Its mission is to make molecular testing actionable, easy, fast, and accessible for any laboratory worldwide, enabling personalized medicine through rapid, accurate biomarker detection. The Idylla™ Platform is a fully automated, sample-to-result system that delivers molecular biomarker results in only 3 hours, facilitating fast treatment decisions and disease management.
Industries
Nr. of Employees
large (251-1000)
Biocartis US, Inc.
Products
Sample-to-result real-time PCR platform
An integrated instrument and single-use cartridge system that automates sample preparation, real-time PCR and result reporting to enable in-lab molecular biomarker testing.
EGFR mutation IVD assay (lung cancer)
In vitro diagnostic assay for detection of EGFR tumor mutations from FFPE tissue with reduced invalid rate and rapid turnaround.
Gene-fusion panel IVD assay (ALK, ROS1, RET, METex14)
Single-cartridge panel for detection of multiple actionable gene rearrangements and MET exon 14 skipping alterations in non-small cell lung cancer, with demonstrated concordance versus reference methods.
MSI IVD assay (colorectal cancer; 510(k) cleared)
In vitro diagnostic microsatellite instability test for colorectal cancer with regulatory clearance referenced.
Sample-to-result real-time PCR platform
An integrated instrument and single-use cartridge system that automates sample preparation, real-time PCR and result reporting to enable in-lab molecular biomarker testing.
EGFR mutation IVD assay (lung cancer)
In vitro diagnostic assay for detection of EGFR tumor mutations from FFPE tissue with reduced invalid rate and rapid turnaround.
Gene-fusion panel IVD assay (ALK, ROS1, RET, METex14)
Single-cartridge panel for detection of multiple actionable gene rearrangements and MET exon 14 skipping alterations in non-small cell lung cancer, with demonstrated concordance versus reference methods.
MSI IVD assay (colorectal cancer; 510(k) cleared)
In vitro diagnostic microsatellite instability test for colorectal cancer with regulatory clearance referenced.
Services
Partnering for assay content and co-development
Collaborative programs with pharmaceutical and diagnostic/biomarker companies to adapt and deploy molecular assays on a sample-to-result platform.
Clinical evidence dissemination
Provision of publications, webinars and educational materials to support clinical use and interpretation of molecular assay results.
Partnering for assay content and co-development
Collaborative programs with pharmaceutical and diagnostic/biomarker companies to adapt and deploy molecular assays on a sample-to-result platform.
Clinical evidence dissemination
Provision of publications, webinars and educational materials to support clinical use and interpretation of molecular assay results.
Expertise Areas
- Clinical molecular diagnostics
- Oncology biomarker testing
- IVD assay development
- Molecular assay validation and performance studies
Key Technologies
- Real-time PCR (qPCR) based sample-to-answer automation
- Cartridge-based single-use consumable systems
- Random-access diagnostics workflow
- FFPE tissue-compatible molecular assays