The ExoDx Lung(ALK) is a plasma-based diagnostic test that detects EML4-ALK mutations in patients with non-small cell lung cancer (NSCLC).

EML4-ALK is a gene fusion that can be observed in a subset of patients with NSCLC, and anticipates response to ALK inhibitor therapies.

Oncologists can use the new test to identify patients from the population of NSCLC patients whose tissue samples are unavailable or unable to undergo repeat biopsy, and provide them with ALK inhibitory therapy.

Exosome Diagnostics president and CEO John Boyce said: "The combined analysis of cfDNA and exoRNA will redefine what is possible for therapy selection, response monitoring, and ultimately early detection and screening.

"Our extensive pipeline is based on our proprietary suite of exosomal diagnostic tools that we have developed over the past eight years, using samples from over 30,000 patients across multiple disease states, and is poised to redefine clinical practice."

According to the company, its proprietary platform for the isolation of RNA from exosomes offers a more direct and sensitive method of detecting fusions such as EML4-ALK compared against cell free DNA (cfDNA) alone.

ExoRNA isolation is suitable to detect fusions such as EML4-ALK, splice variants and RNA transcriptional profiling.

For rare mutation detection, the firm has also developed a novel technology to isolate both exosomal RNA and cfDNA in a single step.

Image: ExoDx Lung(ALK) test has been developed to isolate and analyze exosomal RNA from a blood sample. Photo: courtesy of Suwit Ritjaroon / FreeDigitalPhotos.net.