Quest Diagnostics Launches Three Genetic Test Panels for Predicting Hereditary Cancer Risk

Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced the availability of three new cancer test services designed to provide clinically actionable insight into an individual's risk of developing hereditary forms of cancer. Part of the company's newly branded Quest Vantage™ cancer test menu, the tests and accompanying services are designed to provide physicians and patients with clinically actionable data and related support capabilities, including results interpretation, access to genetic counseling and prior authorization for health plan reimbursement.

The new lab-developed tests feature a 34-gene panel that includes several genes not widely found on existing cancer risk panels. Emerging evidence suggests that the presence of certain mutations of these genes may heighten an individual's likelihood of developing certain types of breast, ovarian, endometrial and other cancers.

"The Quest Vantage service combines the latest advances in laboratory diagnostic technology with unmatched convenience and simplicity," said Christopher Fikry, MD, general manager, oncology, Quest Diagnostics. "With this menu, we deliver on our commitment to provide clinically actionable results based on the latest evidence and guidelines. With these insights, physicians and patients are better positioned to manage cancer risk. Clinicians frequently change the frequency and method of screening as a direct result of genetic test results."

Nearly 1.7 million new cancer cases are expected to be diagnosed in 2016, and as many as 10% of those cancers will be the result of an inherited gene mutation. Insight into hereditary risk enables an individual to consider steps, such as more frequent screening, to potentially detect cancer in an earlier, more treatable stage.

Using next-generation sequencing and a proprietary bioinformatics platform, the new Quest Vantage services together aid the detection of genetic variants associated with inherited risk of 15 cancers, including breast, colorectal, pancreatic and renal. They are:

• MYvantage™ 34-gene Hereditary Comprehensive Cancer Panel, which includes 34 high risk, moderate risk and emerging risk genes associated with a broad spectrum of hereditary cancers.
• GIvantage™ Hereditary Colorectal Cancer Test, which includes 13 genes predominantly associated with colon and gastric cancers.
• Qvantage™ Hereditary Women's Health Cancer Test, which includes 14 genes predominantly associated with breast, colon, uterine, and ovarian cancers.

The tests only include genes meeting certain criteria, such as a two-fold increased cancer risk, association with a disease syndrome for which cancer may occur, and guideline support for genetic counseling. GIvantage and Qvantage panels, designed for patients with a limited subset of cancers in their family history, only include genes for which national guidelines provide medical management recommendations for pathogenic or likely pathogenic gene variants. In addition, each gene variant detected during testing is interpreted according to a rigorous process led by the company's medical experts.

Quest intends to share Quest Vantage variant data with ClinVar, an open variant database. The company also shares BRCA variant data with BRCA Share, a user group it co-founded with Inserm, France's Institute of Health, to broaden access to BRCA gene variants.

With the new offerings, the Quest Vantage menu includes approximately a dozen genetic test panels and single-gene test services, including several BRCAvantage^® services for assessing risk of breast, ovarian and other cancers based on mutations of the BRCA1, BRCA2 and other genes. The number and composition of the Quest Vantage menu was determined based on counsel from oncologists, obstetricians, gynecologists, medical geneticists and genetic counselors.

The services also incorporate the breadth of Quest's national expertise and scale, which includes 2,300 patient service centers, broad health plan relationships and test ordering connectivity through nearly 600 EHR platforms.

In addition, Quest Vantage is designed to support the patient through the entire testing process, with access to third-party genetic counselors services and support for patients through prior authorization and health plan reimbursement. The company also provides financial assistance to qualified uninsured and underinsured patients. Patients may access test results through the company's myQuest™ patient app.

"These capabilities provide patients and physicians with access to the highest quality testing and robust support capabilities" said Dr. Fikry.

The company will showcase the new Quest Vantage offerings at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 3-7 in Chicago (Quest Exhibit 4089).

Quest Diagnostics is a leader in genetic and cancer diagnostic information services. The company offers up to 700 genetic test services and a broad menu of oncology test services that include blood, biopsy and other specimen types. The company was among the first providers to offer PD-L1 companion and complementary diagnostics for immunotherapies for non-small cell lung cancer and melanoma in the United States.