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Idylla EGFR Mutation Assay

Non-Small Cell Lung Cancer (NSCLC)

ApprovedCE-IVD

Key Facts

Indication

Non-Small Cell Lung Cancer (NSCLC)

Phase

Approved

Status

CE-IVD

Company

Biocartis

About Biocartis

Founded in 2007, Biocartis has established itself as a leader in automated, rapid molecular diagnostics with its proprietary Idylla™ platform. Its core mission is to make molecular testing actionable, easy, fast, and suitable for any lab, thereby enabling personalized medicine worldwide. Key achievements include securing FDA approval for its Idylla MSI Test and building a broad menu of RUO and IVD assays, primarily in oncology. The company's strategy revolves around expanding its test menu, deepening market penetration in the US and Europe, and leveraging partnerships to drive platform adoption.

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Therapeutic Areas

Oncology Infectious Diseases

Other Non-Small Cell Lung Cancer (NSCLC) Drugs

Drug	Company	Phase	Status
LW-02 Immunopheresis	Immunicom	Phase 2	Active
ABD-3001	Advanced Biodesign	Phase 1	Active
Macrocyclic OMNI-EGFR Inhibitor	BlossomHill Therapeutics	Phase 1	Active
TUMORIN Clinical Trial	Nilogen Oncosystems	N/A (Diagnostic Validation)	Active
Membrex™	Metaclipse Therapeutics	Pre-clinical	Active
Lazertinib (Leclaza)	Genosco	Approved	Active
IPH5201 (anti-CD39 mAb)	Orega Biotech	Phase 2	Active
Platin-DRP®	Chosa Oncology	Validation	Active
Undisclosed RNA Immunotherapy	Epitopea	Pre-clinical	Active
Aspyre Clinical Test for Lung	Biofidelity	Commercial	Active
EGFR Mutation Detection Assay	Stilla Technologies	Assay Development/Validation	Active
OX-4224	OmRx Oncology	Phase 2	Active