Dive Brief:

• DNA sequencing company Illumina said Tuesday it has received FDA's Breakthrough Device designation for a pan-cancer assay currently in development.
• Illumina is seeking FDA marketing authorization of the assay as a companion diagnostic. The new product will be called TruSight Oncology Comprehensive and is based on the content of Illumina's TruSight Oncology 500 genomic assay for detecting solid tumor biomarkers.
• The company is on a roll with cancer diagnostics, having announced collaborations last April with Bristol-Myers Squibb to develop in-vitro diagnostic assays for oncology and with Loxo Oncology to develop pan-cancer companion diagnostics.

Dive Insight:

Illumina is a major player in the field of gene sequencing that aims to help identify the genetic risks and causes of diseases. In cancer, physicians are increasingly able to use sequence data to identify a patient's cancer type and better target treatment.

The TruSight Oncology Comprehensive assay uses both DNA and RNA from tumor samples to identify key variants underlying tumor progression. These can include small DNA variants, fusions and splice variants, the company said. It can also identify immunotherapy-associated biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI), which are potentially key biomarkers for immunotherapies.

Established by the 21st Century Cures Act, FDA breakthrough device designation is granted to expedite review of technology that demonstrates the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. 

"This is a very significant milestone in the development of a diagnostic device that will allow us to establish standards for accurate and reproducible oncology testing," Garret Hampton, Illumina's senior vice president of clinical genomics, said in a press release. "This designation fast tracks our work with the FDA, so we can bring companion diagnostics to market that pinpoint genomic alterations, giving oncologists the opportunity to select precision therapies to manage their patient's cancer."

The San Diego-based company announced earlier this month that the TruSight Oncology 500 is now shipping. In November, Illumina said it planned to acquire Pacific Biosciences for about $1.2 billion to broaden access to long-read sequencing technologies.