Molecular diagnostics company Genetic Technologies Ltd (ASX: GTG) has commenced initial sales of its GeneType for Breast Cancer Risk Assessment have now commenced in the United States via an online health platform, elicity by InTeleLabs, an independent telehealth and personalised medicine company.
CEO Dr George Mucknicki said the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant health platform enables women meeting the required criteria in the US to purchase the test and receive results via telehealth clinicians.
Its national network of clinical oversight for lab testing has made this ground-breaking Breast Cancer Risk Assessment Test very accessible, with the data-driven results enabling more women to discuss personalised preventative healthcare protocols with their physicians.
GeneType for Breast Cancer is a disease risk prediction test that provides results that inform individuals if they are at low-, average- or high-risk of developing breast cancer. The test uses a patented combination of clinical risk factors and Polygenic Risk Score (PRS) to provide an estimate of the five-year and remaining- lifetime risk of developing breast cancer.
The test will be available in every State throughout the US, as the Company has CLIA certification for the sale and processing for all its lab-derived tests. GeneType for Breast Cancer will sell for US$249 and include the telemedicine consultations through InTeleLabs.
Dr Mucknicki said most tests currently available on the market are for women who have a family history of breast cancer, however 85% of women have no family history of breast cancer, according to the American Society of Clinical Oncology. Further to this, 10% have a family history but no pathogenic variants, such as BRCA.
The company’s GeneType for Breast Cancer is uniquely positioned to provide risk assessment to the general population – not just for women at hereditary risk,” Dr Mucknicki said.
“Our goal was always to give individuals unprecedented access to their own genetic data to understand their health risks and take a more proactive approach to prevention.
“GeneType for Breast Cancer outperforms current standard risk assessment tools, giving clinicians and patients a better way to identify at-risk women for additional breast cancer screening and prevention options. Making this test available via telehealth clinicians gives individuals interested in risk assessment another avenue for access.”
Dr Mucknicki said that once a woman is qualified by an independent telehealth clinician, a buccal swab kit (cheek swab) is sent directly to her home. After her results are in, telehealth clinicians provide post-test consultations to deliver the breast cancer risk assessment results and provide additional support for those who require referrals for appropriate downstream care.