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Illumina (ILMN) Debuts TSO Comprehensive Test in Europe

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Illumina, Inc. (ILMN - Free Report) launched the TruSight Oncology (“TSO”) Comprehensive (EU)— a single test that evaluates multiple tumor genes and biomarkers to identify the specific molecular profile of a patient's cancer. The first global launch of the in vitro diagnostic (“IVD”) kit in Europe will help inform precision medicine decisions for cancer patients throughout the continent.

It is worth mentioning that the TSO Comprehensive (EU) is the first CE-marked IVD kit for comprehensive genomic profiling (CGP) based on DNA and RNA content. It has met stringent European standards for quality and efficacy.

Per management, the groundbreaking and precise diagnostic kit offers information that clinicians can utilize to match their patients to existing therapies based on their tumor profile, according to clinical guidelines or clinical trials.

A Detailed View on TSO Comprehensive (EU)

The TSO Comprehensive (EU) evaluates biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by assessing DNA and RNA, as well as complex genomic signatures, including microsatellite instability and tumor mutational burden. The comprehensive assessment removes the need for running separate, sequential gene tests from multiple biopsy procedures.

The single test has a turnaround time of four to five days for sample-to-clinical report generation compared with weeks in some cases. The fast turnaround time allows clinicians to decide on their cancer patients’ personalized medicine or clinical trial enrollment.

The novel IVD CGP kit covers a wide spectrum of mutations, and current and emerging biomarkers associated with the European Society for Medical Oncology guidelines, drug labels and clinical trials, ensuring that each patient's biopsy yields actionable information. The launch of TSO Comprehensive (EU) as a validated, CE-marked IVD and a kitted solution provides a streamlined method for in-house use by any pathology lab, allowing testing to be offered closer to patient care.

More on the News

Illumina is developing a growing pipeline of companion diagnostics (CDx) claims by partnering with pharma companies, which will be included with TSO Comprehensive (EU) over time, post regulatory authorizations. These CDx solutions will aid in the development of groundbreaking targeted therapies and immunotherapies that will improve cancer patients' lives.

Industry Prospects

Per a report published in MarketsandMarkets, the global cancer/tumor profiling market size is expected to see a CAGR of 10.9% between 2020 and 2025. Factors such as the growing incidence of cancer, increasing use of biomarkers in tumor profiling, rising cancer research and funding initiatives, and several technological advancements in profiling technologies are driving the market.

Given the market prospects, Illumina’s newly launched diagnostic kit for comprehensive genomic profiling comes at an opportune time.

Other Notable Developments

Illumina engaged in a number of significant developments in January 2022.

The company entered a multi-year partnership with Agendia N.V. to co-develop IVD tests for oncology testing. The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina's approach to IVD partnerships in oncology.

Illumina and SomaLogic signed a definitive co-development agreement to bring the SomaScan Proteomics Assay to the former’s existing and future high-throughput NGS platforms. Under the terms of the agreement, Illumina will commence a multi-year development effort to combine SomaLogic's protein target volume with its sequencing technologies, informatics toolsets and DRAGEN software to develop a complete end-to-end NGS workflow solution.

Competitive Niche

The cancer diagnostics market is competitive with the presence of prominent MedTech players.

In this regard, we may note that NeoGenomics, Inc.’s (NEO - Free Report) liquid biopsy focused subsidiary, Inivata Limited, which recently gained the CE mark for its RaDaR assay for the identification of molecular residual disease and recurrence, after meeting the requirements of the European In-Vitro Diagnostics Directive (98/79/EC). The RaDaR liquid biopsy assay uses a simple blood draw to track a set of up to 48 tumor-specific variants in a patient.

Another notable player, Thermo Fisher Scientific Inc. (TMO - Free Report) , received the FDA premarket approval for its Oncomine Dx Target Test as a CDx to identify non-small cell lung cancer (NSCLC) patients with tumors carrying the epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT (amivantamab-vmjw). The regulatory authorization will allow clinicians to use formalin-fixed, paraffin-embedded tissue samples to identify patients who may benefit from treatment with RYBREVANT in the United States.

QIAGEN N.V. (QGEN - Free Report) received the FDA premarket approval for its therascreen KRAS RGQ Polymerase Chain Reaction (PCR) Kit to be used as a CDx in guiding treatment with the lung cancer targeted drug LUMAKRAS (sotorasib). The therascreen KRAS RGQ PCR Kit identifies the KRAS G12C mutation in NSCLC tumor tissue samples. The company also launched an expanded scope of CDx claims for the therascreen KRAS Kit following the approval.