Combined with other clinical risk factors the test provides a comprehensive risk assessment in a simple saliva test.

Highlights:

• New test integrates the patented and proprietary GeneType platform for both Breast and Ovarian Cancer.
• GTG’s unique approach “appends” the detection of the 13 major “actionable” breast and ovarian cancer susceptibility genes to the GeneType test platform.
• Results in a higher classification rate of women at elevated risk of breast and ovarian cancer than traditional clinical tools by assessing breast and ovarian cancer susceptibility from both rare and common genetic variants in addition to other known clinical risk factors associated with the development of both diseases.
• Advances the goal of providing population-based genetic screening for Breast and Ovarian cancer where up to 85% of cancers diagnosed do not have hereditary or family history¹.
• The new test platform addresses those women over 30 years of age in the general population that are at higher risk of developing breast and/or ovarian cancer, not just from rare genetic mutations.
• The comprehensive risk assessment test will be clinically validated and have appropriate regulatory approval.
• This test will be launched via our Business to Business (‘B2B’) and Consumer Initiated Testing (‘CIT’) channels in the United States.
• The Comprehensive Risk Test will be showcased at the BRCA 2023 Symposium in Montreal in early May.

Globally, there are more than 2.26 million cases of Breast Cancer² and 313,000 cases of Ovarian Cancer³ diagnosed annually. In the USA there are 297,790 new cases of invasive breast cancer that are diagnosed annually⁴ and 19,880 women diagnosed with ovarian cancer⁵.

Currently women are under-screened and underdiagnosed for risk of hereditary breast and ovarian cancer syndrome (HBOC) based on their clinical criteria. There is considerable evidence that these criteria do not capture all women who are HBOC carriers. One recent general population screen among more than 6,000 women found that of 38 HBOC carriers identified nearly half would not have qualified for HBOC testing based on clinical criteria and their elevated risk of cancer would not have been identified.

GTG’s comprehensive risk assessment for both cancers inform women of their risk profile and as a result, the opportunity to take proactive actions to increase screening and lessen their risk of developing these diseases. The risk assessment is performed from a single saliva sample and a brief questionnaire.

Implementation of the test as a population-based genetic screening for Breast and Ovarian is supported by GTG’s independently developed Budget Impact Model (‘BIM’) providing a strong health and economic case for payers and insurers in the U.S. Supplemental screening in a subpopulation of women identified as at-risk by geneType can lead to an increase in early-stage, screen-detected cancers, which in turn is associated with high 5-year survival rates 99%⁶ and 93%⁷ for breast and ovarian, respectively.

GTG’s CEO, Simon Morriss, commented: “GTG believes this Comprehensive Risk Test for Breast and Ovarian Cancer is one of our most important and significant contributions to the advancement of population-based genetic testing. We are moving beyond rare cancer-susceptibility genetics. We can look for the needle in the haystack, but we are also able to look at the haystack itself. Our non-invasive risk assessment test will address cancer risk at a population health level.”