Clinical OMICs - Volume 3, Issue 9 - 23

(continued from page 21) cancer screening based on risk profile is more effective than a one-size-fits-all approach. Last year, Color Genomics launched its $249 Color Test, which is designed to analyze 30 genes associated with increased risk for the most common hereditary cancers. Doctor's Orders Unlike 23andMe, which allows individuals to order its test online, Color requires that its test be ordered by a patient's physician or one from its external network of independent physicians. Pathway Genomics has a similar policy for its 14 genetic tests, which patients can order via their doctors or the company's online physician network, and takes issue with being called a DTC testing company, which the FDA defines as genetic tests, "mar- Color Genomics launched its $249 Color Test, which is designed to analyze 30 genes associated with increased risk for the most keted directly to consumers via television, print adver- common hereditary cancers. tisements, or the Internet." Pathway's policy helped it overcome a challenge from ing patients; and a colorectal cancer detection study in the FDA, which has cast a wary eye on DTC testing. [See 200 patients undergoing colonoscopies. page 22] Pathway has completed two earlier One of Pathway's priorities has been studies. Healthy 100 studied the blood clinically validating its CancerIntersamples of 102 asymptomatic individu"We're equally focused cept Detect blood-based non-invasive als with no cancer diagnosis or high-risk on gathering data test, designed to detect the presence features. The study found one cancer of circulating tumor DNA (ctDNA) of driver mutation in a gene associated and providing testing. nine cancer driver genes. While Pathwith cancer in three participants, and The goal is to take our way's website cites costs of between two driver mutations in a fourth. responsibility seriously $299 and $699 per test, a spokesperThe other study compared the circuto protect the public, son told Clinical OMICs the quoted lating tumor DNA (ctDNA) levels in 45 but also to be able to range is "not too far off" from the curpatients diagnosed with Stage 1-2 canshare information rent range, with prices varying by marcer and 36 with Stage 3-4 cancer across and advanced technology." ket and distributor. all 11 cancer types. Cancer driver mutaIn May, Pathway joined the Thyroid & tions were detected in six patients with - Pathway Genomics Endocrine Center of Florida to launch a Stage 1 cancer and 18 with Stage 3-4 clinical trial of CancerIntercept Detect's cancer. ability to detect mutations linked to thyroid cancer. The A Pathway spokesperson told Clinical OMICs it has no trial is Pathway's third ongoing study for CancerIntercept partnerships with drug developers at present. "We're Detect. equally focused on gathering data and providing testing. Other Pathway research includes Pathway Healthy 1000, The goal is to take our responsibility seriously to protect a study of 1,000 asymptomatic individuals not diagnosed the public, but also to be able to share information and with cancer but at high risk for which it is currently enroll- advanced technology." www.clinicalomics.com September 2016 Clinical OMICs 23 http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9