Exosome Diagnostics has presented data that sets a new standard for EGFR-T790M resistance mutation detection in lung cancer, with the highest sensitivity reported to date.
This test is being developed to improve care and outcomes for the large population of patients who can benefit from second line EGFR Tyrosine Kinase Inhibitor (TKI) therapy but are missed with currently available tissue and liquid biopsy tests.
Clinical validation data from a cohort of 160 patients, the largest of its kind in this patient population, was presented in plenary session during the recent AACR-EORTC-NCI meeting in Munich, Germany.
ExoDx Lung (T790M) has been optimally designed for ExosomeDx’s high throughput biomarker testing platform that is being deployed in 2017.
Twenty percent of non-small cell lung cancer (NSCLC) patients test positive for an EGFR driver mutation (approximately 45,000 patients in the U.S. alone) and receive EGFR TKI therapy. Unfortunately, most will develop a resistance to EGFR TKI therapy.
Tissue biopsies are the current standard for identifying T790M resistance. If a patient tests positive, they are eligible for treatment with a second line EGFR TKI therapy. Unfortunately, a tissue biopsy is not always a viable option for a large percentage of these patients.
Non-invasive liquid biopsies have emerged as a viable alternative for patients unable to have tissue biopsy procedure. Clinical studies have demonstrated that the FDA approved cobas® test for liquid biopsy, only identifies 59% of patients who will respond to a second line EGFR TKI therapy.
This is a direct result of lack of sensitivity and inability to test challenging intrathoracic disease. By analyzing exosomal RNA (exoRNA) and cell free tumor DNA (ctDNA) from the same sample Exosome Dx addresses current limitations by identifying 96% of the T790M positive population, with no loss of sensitivity in patients with intrathoracic disease.
“EGFR T790M mutations have previously been challenging for liquid biopsy assays. In this clinical study, we show that ExoDx Lung(T790M) has a higher clinical sensitivity and specificity than what has been reported to date for the FDA cleared test distributed by Roche.
This study further demonstrates the power of our ExoLution Plus platform that combines exoRNA plus ctDNA. This result was not surprising since we have shown superior performance to ctDNA across several disease states in blinded head to head studies.
Clinical samples are precious so we are thrilled to be able to offer a more sensitive test that take both exoRNA and ctDNA into consideration,” stated Dr. Johan Skog, Chief Scientific Officer at Exosome Diagnostics.
The test is the latest in a series of biofluids based diagnostic and companion diagnostic biomarker tests being developed by Exosome Diagnostics to potentially aid in therapy selection and patient monitoring in oncology and other diseases.
To assure future access to the company’s novel biomarker tests worldwide, Exosome Diagnostics also announced that it has developed a high throughput version of its proprietary ExoLution Plus system to prepare samples that can be analyzed with exoRNA and cfDNA analysis test kits.
This system utilizes Exosome Diagnostics’ patented technology and has been developed with high throughput capability to be integrated with leading clinical laboratory analytical systems including those marketed by Roche and Thermo Fisher.
“This data illustrates one of the many indications for which Exosome Diagnostics can leverage its extremely sensitive liquid biopsy technology to improve patients’ lives by guiding therapy, where other technologies could not in a reliable fashion,” stated John Boyce, President and CEO of Exosome Diagnostics.
“Exosome Diagnostics has proven that its technology is extremely robust and can scale on a variety of existing commercial platforms in diagnostic laboratories,” Boyce continued.