Pathway Genomics Provides Updates for CancerIntercept™ Detect Clinical Program

SAN DIEGO May 26, 2016  – Pathway Genomics today provided an update on the clinical development program for its liquid biopsy, CancerIntercept™ Detect, a non-invasive screening test for detection of mutations that have been associated with cancer. Pathway Genomics researchers have initiated a clinical trial for the detection of thyroid cancer – the company’s third ongoing study for the technology. The company also announced the publication of two abstracts in the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings.

“The initiation of the thyroid study is an important step in our clinical development program for CancerIntercept and will help increase our understanding of its potential as a biomarker for the early detection of thyroid cancer,” said Glenn Braunstein, M.D., chief medical officer of Pathway Genomics. “We are in the process of initiating additional disease specific studies for early cancer detection in high risk patients, including a study in lung cancer, and will present and publish the data in the appropriate forums.”

Clinical Trials

Pathway Genomics initiated a clinical investigation with the Thyroid & Endocrine Center of Florida in Sarasota, Florida, to explore the ability of CancerIntercept to detect mutations associated with thyroid cancer. The study will enroll 150 patients and compare detection through CancerIntercept with fine needle aspiration (FNA) biopsy, which is the standard of care for thyroid cancer detection.

In addition, Pathway Genomics continues to enroll patients in two ongoing clinical trials – Healthy 1000 and a colorectal cancer detection study. Healthy 1000 is enrolling 1,000 asymptomatic individuals who have not been diagnosed with cancer but are at a high-risk due to certain factors such as genetic predisposition, age or environmental exposure. The colorectal study, titled Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy, is enrolling 200 patients who are undergoing diagnostic colonoscopies for detection of colon cancer.

Data in 2016 ASCO Annual Meeting Proceedings

The first study published in the ASCO Annual Meeting Proceedings is titled “Mutation detection in cell free DNA from healthy donors.” Pathway Genomics researchers evaluated blood samples from 102 asymptomatic individuals who had not been diagnosed with cancer and did not have any particular high-risk features. The study, known as Healthy 100, identified at least one mutation in a gene that has been associated with cancer above a pre-set threshold in four individuals. These individuals were subsequently monitored every two to three months, and mutation levels remained consistent. One individual had multiple mutations and revealed several lung nodules in a CT scan and colonic polyps. Additional follow-up is continuing with these patients.

In a second study, researchers from Pathway Genomics compared the circulating tumor DNA (ctDNA) levels in 45 patients diagnosed with Stage 1-2 cancer and 36 patients with Stage 3-4 cancer. The study across all 11 different cancer types found that 6 patients with Stage 1 cancer (14%) had mutations as compared to 18 patients with Stage 3-4 cancer (50%). In addition, the mutations found in the Stage 1 patients were recurrent in TP53, GNAS and KRAS, while the mutations found Stage 3-4 patients were spread across seven of the nine genes analyzed by CancerIntercept.

About Pathway Genomics

Founded in late 2008, Pathway Genomics has rapidly become a leader in the commercial healthcare industry. Pathway Genomics’ success lies in its commitment to deliver innovative healthcare solutions. The company’s smartphone app program with IBM Watson is the first of its kind that merges artificial intelligence and deep learning with personal genetic information. The app provides users with personalized health and wellness knowledge based on the individual’s health history.

Based in San Diego, the company’s CLIA and CAP accredited clinical laboratory provides physicians and their patients in more than 40 different countries with actionable and accurate precision healthcare information to improve, or maintain, health and wellness. Pathway Genomics’ testing services cover a variety of conditions including cancer risk, cardiac health, inherited diseases, nutrition and exercise response, as well as drug response for specific medications including those used in pain management and mental health. For more about Pathway Genomics, visit www.pathway.com or follow us on Twitter, LinkedIn and Facebook.

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