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Illumina (ILMN), Merck Ink Cancer Companion Diagnostics Deal

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Illumina, Inc. (ILMN - Free Report) recently partnered with Merck & Co., Inc. (MRK - Free Report) to develop and market tests that detect genetic alterations used in the assessment of homologous recombination deficiency (HRD). The HRD tests will make use of Illumina's TruSight Oncology 500 (TSO 500) content, which allows for the most comprehensive genomic profiling assays in a single workflow.

Illumina will develop a new HRD companion diagnostics (CDx) test for the EU and the U.K. for the identification of ovarian cancer patients with positive HRD status, who are eligible for treatment with LYNPARZA (olaparib). The LYNPARZA is a first-in-class PARP inhibitor, which is jointly developed and commercialized by Merck and AstraZeneca.

Illumina will also develop and market an HRD assay for research use only (RUO). This test will be add-on content for the TSO 500 RUO panel. The company intends to launch this product globally, with the exception of the United States and Japan.

Illumina’s recent collaboration with Merck builds on its solid history and is likely to expand its broad portfolio of oncology partnerships with industry leaders.

More on the Collaboration

Illumina’s recent collaboration builds on a previous study with Merck that focused on the expanded TruSight Oncology HRD offering. This partnership also leverages the company’s relationship with Myriad Genetics, Inc. (MYGN - Free Report) to broaden international access to the proprietary technology in Myriad's FDA-approved myChoice CDx test. Notably, Illumina partnered with Myriad to develop and commercialize distributed kits with time-limited exclusivity in certain markets for the assessment of HRD and to enable Myriad expand its HRD service offerings through a combination of TruSight Oncology content and Myriad’s myChoice CDx test.

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Illumina aims to offer the best-in-class HRD assay that is widely accessible by leveraging its comprehensive genomic profiling family of products, the TruSight Oncology and myChoice HRD technology. The combined expertise of Illumina and Merck’s incredible medicines development capabilities is expected to create a real difference for patients by leveraging the usage of precision medicines.

Few Words on TruSight Oncology & myChoice CDx

The TSO 500 is a RUO pan-cancer assay that is designed to identify known and emerging tumor biomarkers across 523 genes. This assay utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression. Additionally, it evaluates key immune-oncology biomarkers, such as Tumor Mutational Burden and Microsatellite Instability.

The myChoice CDx is the first and only FDA-approved tumor test that determines homologous recombination deficiency status through BRCA1 and BRCA2 variants detection. It evaluates genomic instability utilizing three key biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.

Industry Prospects

Per a report published in Grand View Research, the global oncology companion diagnostic market is set to witness a CAGR of 12.7% during 2020-2027. Factors driving market growth include evolving role of oncology companion diagnostics in the era of next-generation omics; increased adoption of oncology CDx assays by pharmaceutical manufacturers given their several economic benefits coupled with the ability to reduce clinical trial timelines; and improvement in drug and diagnostics co-development models since the issuance of “In Vitro Companion Diagnostic Devices” guidance by the FDA in 2016.

Given the market prospects, Illumina’s recent collaboration to develop CDx for LYNPARZA seems well-timed.

Notable Developments

In August 2021, Illumina acquired GRAIL, a healthcare company focused on life-saving early detection of multiple cancer. However, the company will hold GRAIL as a separate company throughout the ongoing regulatory review by the European Commission. This acquisition is expected to accelerate the access and adoption of GRAIL's life-saving Galleri blood test worldwide. This test can identify 50 different cancers before they become symptomatic.

In April 2021, the company partnered with Kartos Therapeutics, Inc. to co-develop a TP53 companion diagnostic based on the content of Illumina’s comprehensive genomic profiling assay, TruSight Oncology 500. The TP53 CDx will be the first to use TSO 500 with peripheral whole blood as a diagnostic sample type. This partnership is expected to expand Illumina’s TruSight Oncology offerings into hematologic malignancies.

Share Price Performance

The stock has outperformed its industry over the past year. It has rallied 35.4% against the industry’s growth of 8.2%.

Zacks Rank and Key Picks

Currently, Illumina carries a Zacks Rank #3 (Hold).

A better-ranked stock from the Medical-Biomedical and Genetics industry is Moderna, Inc. (MRNA - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 29.1%.

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