Illumina, AstraZeneca, Janssen and Sanofi to pursue universal companion Dx test

Illumina ($ILMN) has inked deals with three major Big Pharma companies with the goal of developing a universal gene-sequencing companion diagnostic test system focused on cancer.

The San Diego, CA-based company plans to work initially with AstraZeneca ($AZN), Janssen Biotech and Sanofi ($SNY), with other strategic partners envisioned down the line.

Illumina's initiative is very much focused on advancing the industry's approach toward companion diagnostics with an eye on making things both broader and more efficient. The goal is to develop and commercialize a universal next-generation sequencing test system for cancer that would use a multigene testing panel to help select the best drugs for treating individual patients. It would be useful, ideally, both in drug development and in everyday use.

"Illumina is developing the universal test system to support our partners' oncology drug pipelines," Illumina Chief Medical Officer Rick Klausner said in a statement. "These agreements represent the deep engagement between Illumina and the pharma community to create the technical, clinical, regulatory and ultimately commercial solutions for the next generation of molecular oncology."

The advance would represent a move away from single-analyte companion diagnostic tests more common in the industry right now, to panel-based assays that help select ideal cancer treatments.

With that in mind, here's where Illumina's work with AstraZeneca, Janssen, Sanofi and other strategic partners will come in. If all goes well, they'll produce assays that help detect and measure a number of cancer variants that support the Big Pharma partners' clinical trials. The goal is to gain approval and commercialization for those tests. But there's more. Illumina said it is also working to develop standards for next-generation-based assays for use in routine clinical cancer practice. The company also wants to help define the regulatory boundaries for this diagnostic approach.

There is definitely room in the market for a more efficient approach. As Illumina notes, researchers have discovered 125 cancer driver genes so far, that propel tumor growth through 12 cellular signaling pathways. The company noted that while targeted cancer drugs are limited in number right now, 800 oncology drugs are in development that would hit specific cancer mutations. Clinicians can maximize the benefits of these drugs with companion diagnostic tests, so Illumina's approach will be worth watching in the months ahead.

- read the release

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