New colon cancer test launched

 13th May 2015

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, announces the launch of its next generation sequencing (“NGS”) technology PrecisionPath™ in partnership with Greenville Health Systems (“GHS”), one of the leading cancer institutes in the US. For the first time patients will have wider access to affordable advanced NGS testing that can help doctors determine the most effective cancer treatments based on an individual’s genetic profile.

The launch of the PrecisionPath™ Colon by EKF’s subsidiary Selah Genomics (“Selah”), follows a successful one year trial with GHS, one of the leading cancer institutes in the US, and will be the first commercial NGS panel molecular test for invasive colon cancer priced under US$1,000 with a target turnaround time of less than 7 days per reportable result.  

PrecisionPath™ can be used by oncologists nationally to identify the specific growth drivers for colon cancer in an individual based on their genetic make-up and to, ultimately, ensure the most effective therapy is used at all times during treatment. By identifying the cancer’s specific susceptibility to available treatments, PrecisionPath™ will help oncologists select the most effective options for a patient based on the patient’s tumor type.

The advantage of the PrecisionPath™ Colon test panel is that it focusses on a key number of actionable biomarkers which provide maximum clinical utility at a more affordable cost. The panel provides a clear and concise report that differentiates between those genes with proven clinical utility and others under clinical trial investigation. As the body of evidence for clinical utility grows, reports will be updated accordingly, providing doctors with a means to routinely integrate genomic analysis into the everyday care of cancer patients.

Initially PrecisionPath™ Colon will be available across GHS’s oncology treatment centres. According to the American Cancer Society and the US National Cancer Institute, colorectal cancer (CRC) death is the second leading cause of cancer death in the US in men and women combined, with close to 50,000 patients predicted to die in 2015 and more than 130,000 new cases of colorectal cancer being diagnosed. In Europe, it is predicted that there will be close to 450,000 new cases of colorectal cancer diagnosed in 2015. EKF will then expand the service throughout the US targeting oncologists and pathologists treating patients with invasive CRC. EKF intends to offer PrecisionPath™ in additional indications, including lung cancer, breast cancer and melanoma beginning in late 2015.

EKF and GHS’ commercialisation partnership strengthens an already successful relationship, which began in March 2012 with the formation of Selah’s Clinical Genomics Centre at GHS. PrecisionPath™ has been developed in close association with some of the US’s leading cancer specialists from the initial piloting programme at the GHS Institute for Translational Oncology Research (GHS ITOR) in May 2013 until today’s commercial launch. This partnership exists alongside the 18 month collaboration announced on 2 March 2015 which is part funded by Becton Dickinson and Company and brings together Selah’s NGS technology and DecisionQ artificial intelligence-based decision support algorithms.

Julian Baines, CEO of EKF, commented: "The launch of PrecisionPath™ Colon, at a price under $1,000 coupled with a 7 day turnaround time, demonstrates EKF’s commitment to providing affordable access to world-class diagnostic testing to oncologists treating patients across the US.  It remains our goal to secure reimbursement from public and private payers for PrecisionPath™ and we believe our case is strengthened by our focus on invasive colon cancer and the very clear guidelines that support clinical utility in this area.”