Response Genetics, Inc., a company focused on the development and sale of molecular diagnostic tests for cancer, has launched testing for ROS1 gene rearrangements.  

Recently, the Massachusetts General Hospital Cancer Center (MGH) published studies showing that ROS1 driven tumours are sensitive to the FDA approved drug xalkori (crizotinib) to treat non-small-cell lung cancer (NSCLC) patients with ALK gene rearrangements.  Tumours driven by rearrangements in the ROS1 gene represent an additional 1 to 2 per cent of patients who may be candidates for crizotinib therapy. The company will offer both fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) based ROS1 translocation testing.

"We are pleased to add ROS1 to our growing test menu," said Thomas Bologna, chairman and CEO of Response Genetics.  "We believe the dual option of FISH and PCR represent a unique offering and is consistent with our Leave No Stone Unturned programme whereby we go to great lengths to help patients receive optimal therapy.  While FISH is the technology that has been used for ROS1 to date, PCR has the advantage of providing additional information about the variant found, information that may be useful for evaluating response and resistance mechanisms.  This promising new marker is now readily available to pathologists and oncologists seeking fast turnaround time and utilizes the company's proprietary methods that enable results on very small biopsies including fine needle aspirates."

ROS1 supplements the company's recently introduced Leave No Stone Unturned programme, in which patients whose tumours test negative for the ALK Break Apart FISH assay receive follow-up ALK testing using the company's proprietary EML4-ALK RT-PCR-based assay at minimal additional cost.  With the addition of ROS1, ordering clinicians can now make a more complete evaluation of each of their NSCLC patients as candidates for crizotinib therapy.  

Response Genetics, Inc. is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. The company's technologies enable extraction and analysis of genetic information derived from tumour cells stored as formalin-fixed and paraffin-embedded specimens.