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Illumina (ILMN) to Offer Companion Diagnostic for VITRAKVI

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Illumina, Inc. (ILMN - Free Report) recently added a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test. The CDx pan-cancer indication will identify cancer patients with solid tumors positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions, including NTRK1, NTRK2 or NTRK3. The patients would benefit from targeted therapy with Bayer's VITRAKVI (larotrectinib) in line with the authorized therapeutic labeling.

The TSO Comprehensive (EU) evaluates multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. It is a comprehensive genomic profiling test, which integrates less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This increases the likelihood of detecting an actionable alteration, allowing patients to be treated with targeted therapy or enrolled in a clinical trial based on their tumor genomic profile.

The first CDx claim for the TSO Comprehensive (EU) presents an opportunity for patients with NTRK gene fusions to benefit from larotrectinib, a genomically matched treatment.

More on the CDx Indication

The CDx indication for the TSO Comprehensive (EU) was developed in partnership with Bayer. Unlike most CDx tests, the NTRK claim is pan-cancer, allowing TSO Comprehensive (EU) to target several solid tumor types and a wide spectrum of known and novel gene fusion partners across all three NTRK genes. This maximizes the chances of obtaining useful information from each patient's biopsy to guide treatment with larotrectinib.

The performance of TSO Comprehensive (EU) with NTRK fusions was evaluated by analytical and clinical validation studies. The clinical effectiveness and safety of TSO Comprehensive (EU) in detecting NTRK1, NTRK2 and NTRK3 gene fusion-positive patients eligible for treatment with larotrectinib, were demonstrated using pooled data from three clinical trials: LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687).

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Per Bayer's management, the CE marking of Illumina's TSO Comprehensive (EU) assay, inclusive of NTRK gene fusion detection for VITRAKVI, is a significant step forward in enabling precision oncology for European patients. Both companies will continue to collaborate to ensure that more patients are assessed comprehensively, including those with NTRK gene fusions.


Industry Prospects

Per a report published in MarketsandMarkets, the global companion diagnostics market is expected to see a CAGR of 12.6% from 2021 to 2026. Factors such as the growing importance of companion diagnostics in drug development, increasing cancer instances and greater uptake of targeted therapies are driving the market.

Given the market prospects, Illumina’s first CDx claim for the TSO Comprehensive (EU) comes at an opportune time.

Other Notable Developments

Illumina is engaged in a number of significant developments in May 2022.

The company partnered with Allegheny Health Network to assess the impact of in-house comprehensive genomic profiling on improving patient care. The collaboration will evaluate the value of in-house testing for tissue and blood samples compared to sending those samples externally and whether this approach would benefit cancer patients and the broader healthcare system.

The company also entered into a five-year partnership with Deerfield Management to apply a genetic-led approach to discovering and developing novel therapies for diseases with unmet medical needs. The objective of the collaboration is to use genomic tools and genetic knowledge to identify programs with a higher probability of success, lowering research and development costs and speeding up the approval of cutting-edge therapies.

Price Performance

The stock has underperformed its industry in the past year. It has dropped 39.6% compared with the industry’s 38.3% fall.

Zacks Rank and Key Picks

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

A few better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Masimo Corporation (MASI - Free Report) .

AMN Healthcare has a long-term earnings growth rate of 1.1%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.6%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has declined 0.8% compared with the industry’s 64% fall.

Medpace has a historical growth rate of 27.3%. Medpace’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%. It currently has a Zacks Rank #2 (Buy).

Medpace has outperformed its industry in the past year. MEDP has declined 19.6% compared with the industry’s 64% fall.

Masimo has a historical growth rate of 15.1%. Masimo’s earnings beat estimates in each of the trailing four quarters, the average surprise being 4.4%. The company currently carries a Zacks Rank #2.

Masimo has underperformed the industry in the past year. MASI has declined 34.5% compared with a 17.7% fall of the industry.