New FDA-cleared lung cancer test, Roche AVENIO Tumor Tissue CGP kit targets NSCLC labs

Roche’s AVENIO Tumor Tissue CGP Kit gives molecular pathology labs a distributed, FDA-cleared comprehensive genomic profiling test for non-small cell lung cancer, with hybrid-capture NGS, a 324-gene panel and in-house workflow control.

Edited by ad hoc news New Releases & Launches Desk. Reviewed before publication on 06/16/2026 at 8:40 AM ET. Details in the imprint.

Roche is expanding its footprint in lung cancer diagnostics with the recently FDA-cleared AVENIO Tumor Tissue CGP Kit, a comprehensive genomic profiling solution that allows molecular pathology labs to run a non-small cell lung cancer (NSCLC) panel entirely in-house rather than sending samples to central services. The kit is positioned as a distributed test for formalin-fixed, paraffin-embedded (FFPE) tumor tissue, combining hybrid-capture next-generation sequencing (NGS) with a curated 324-gene panel designed to capture the key biomarkers driving NSCLC treatment decisions. According to Roche, the AVENIO Tumor Tissue CGP Kit is FDA-cleared specifically for use in patients with advanced or metastatic NSCLC to identify genomic alterations that may inform targeted therapies and clinical trial options, effectively turning hospital and reference labs into their own CGP service providers. Roche’s official product page details the intended use and panel content.

What the AVENIO Tumor Tissue CGP Kit does in the lab

The AVENIO Tumor Tissue CGP Kit is built around a hybrid-capture workflow that extracts and enriches tumor DNA from FFPE samples, feeding it into an Illumina-based NGS pipeline that reports single-nucleotide variants, insertions and deletions, copy number changes and select gene fusions across 324 cancer-relevant genes in a single assay. The FDA-cleared configuration for NSCLC focuses on clinically significant markers such as EGFR, ALK, ROS1, BRAF, MET, RET and KRAS, but the underlying panel is broader, allowing laboratories to generate data that may also support research, internal validation and future clinical applications on the same technical backbone. Roche emphasizes that the kit is delivered as a complete package including reagents, library preparation components, target enrichment probes and bioinformatics specifications, with the goal of standardizing runs across sites while still leaving labs control over sample logistics and reporting formats. The company’s launch material highlights that the CGP kit is intended to complement, rather than replace, existing single-biomarker tests like PCR or IHC, particularly in settings where tissue is limited and a broader molecular picture is needed from a single biopsy. Independent industry coverage notes that distributed CGP kits such as AVENIO can help reduce turnaround times by avoiding the shipping delays inherent in send-out services, a factor that can be critical when oncologists are choosing first-line therapy in late-stage NSCLC. A report in The Scientist describes the kit’s role in expanding access to CGP.

From a technical perspective, the AVENIO Tumor Tissue CGP Kit is designed for moderate to high-throughput labs that already operate Illumina NGS systems, with Roche specifying run configurations that allow batching of multiple samples per flow cell to control per-sample cost. The workflow starts with DNA extraction from FFPE curls or sections, followed by fragmentation, adapter ligation and hybrid capture using probe sets tailored to the panel, then amplification and sequencing, after which Roche provides software pipelines and variant calling parameters validated during FDA clearance. The company states that analytical validation included precision, reproducibility and limit-of-detection studies across a range of allele frequencies typical of heterogeneous tumor samples, giving labs a regulatory-backed performance envelope for their own quality management systems. For US customers, Roche positions the AVENIO Tumor Tissue CGP Kit as a way for hospital networks to internalize CGP testing that might otherwise be outsourced to central labs, which can help keep revenue and data in-house while potentially offering oncologists faster and more flexible reporting.

Clinically, the AVENIO Tumor Tissue CGP Kit targets advanced or metastatic NSCLC cases where guideline-concordant care increasingly requires a broad molecular work-up, including EGFR activating and resistance mutations, ALK and ROS1 rearrangements, BRAF V600E, MET exon 14 skipping, RET rearrangements, NTRK fusions and KRAS G12C. Roche notes that the CGP kit supports the identification of these and other variants with a single test, allowing labs to move beyond sequential single-gene assays that can consume tissue and extend turnaround times. The comprehensive approach aligns with evolving recommendations from oncology societies that favor upfront broad profiling when feasible, particularly for non-squamous NSCLC, so that patients are not cycled through multiple biopsies or delayed in accessing targeted therapies. For pathologists, an in-house CGP workflow can also ease coordination with tumor boards and molecular tumor conferences, as raw data and variant classifications remain within the institution and can be revisited as new therapies gain approval.

The AVENIO Tumor Tissue CGP Kit sits alongside Roche’s broader oncology diagnostics portfolio, which spans IHC antibodies on the BenchMark staining platforms, blood-based assays and digital pathology tools, giving the company a multi-modality offering for cancer centers looking to standardize on a single supplier. Roche has also developed a complementary AVENIO ctDNA CGP solution for plasma, reflecting the trend toward liquid biopsy in cases where tissue is scarce or re-biopsy is not feasible, though the FDA-cleared tissue kit remains the primary regulatory-backed option for NSCLC CGP in many institutions. Competitive pressure in this segment is high, with large US reference labs offering their own FDA-approved or -authorized CGP tests as centralized services, so Roche’s strategy of enabling distributed testing aims to differentiate on control and integration rather than just on panel content. Market analysts see comprehensive genomic profiling as one of the faster-growing categories in oncology diagnostics, as targeted therapies and immunotherapies expand, and as payers become more willing to reimburse broad panels when they clearly support guideline-based treatment choices and reduce downstream costs associated with ineffective therapies.

Within Roche’s diagnostics division, oncology testing is a central growth driver and a strategic complement to the group’s oncology drug portfolio, which includes targeted therapies and immunotherapies that also depend on biomarker identification for optimal use. The company does not break out revenue by individual assay, but management has repeatedly highlighted molecular diagnostics and next-generation sequencing as focus areas for investment and partnerships, indicating that the AVENIO Tumor Tissue CGP Kit is part of a broader push into linked diagnostics and therapeutics. Shares of Roche Holding AG (ISIN CH0012032048) are listed on SIX Swiss Exchange in Zurich; the group reports its diagnostics and pharmaceuticals performance in Swiss francs, and the stock remains a bellwether for European healthcare exposure. Recent trading data on Yahoo Finance show the US ADR under the ticker RHHBY.

AVENIO Tumor Tissue CGP Kit in brief: key facts

• Product: AVENIO Tumor Tissue CGP Kit
• Manufacturer: Roche Holding AG
• Category: New Release/Launch - oncology diagnostics CGP kit
• Launch date: FDA clearance announced in 2024 for NSCLC CGP
• MSRP / Price: Not publicly disclosed; pricing typically negotiated with hospital and reference labs
• Availability: Distributed through Roche Diagnostics for molecular pathology labs using Illumina NGS platforms in the US and selected international markets
• Target audience: Hospital molecular pathology labs, reference laboratories and cancer centers performing comprehensive genomic profiling in advanced or metastatic NSCLC
• Key differentiator / USP: FDA-cleared, distributed comprehensive genomic profiling kit enabling in-house NSCLC testing across a 324-gene hybrid-capture panel

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