Clinical Use

• Confirm hyper-methylated DNA from multiple gene targets
• Streamline the confirmation of multiple cancer types in patients with abnormal standard of care testing

Testing Method

• Liquid biopsy
• Blood draw: no centrifuge, freezing, or fasting

Clinical Necessity

In 2018, Breast, Colon, Liver, and Lung cancer took the lives of more than 600k individuals. More than 1 million more individuals were diagnosed with those cancers, during that same year. See cancer statistics below.

Death rates increase by more than 50% for over 25 types of cancer if confirmed in later stage

Breast cancer: more than 90% of women diagnosed with breast cancer at the earliest stage survive their disease for at least 5 years compared to around 15% for women diagnosed with the most advanced stage of disease

Bowel cancer: more than 9 in 10 bowel cancer patients will survive

the disease for more than 5 years if diagnosed at the earliest stage

Lung cancer: more than 80% of lung cancer patients will survive for at least a year if diagnosed at the earliest stage compared to around 15% for people diagnosed with the most advanced stage of disease

Liver Cancer: patients with early-stage tumors that can be removed surgically have the best chance of long-term survival. Unfortunately, most liver cancers are inoperable at the time it’s diagnosed, either because the cancer is too advanced or the liver is too diseased to permit surgery

Methylation is an epigenetic marker that acts both as an indicator and regulator of gene expression. In essence, by identifying which genes are turned on or turned off, we may identify when cancer is present. Methylation, as an epigenetic marker, is standard in both healthy patients and patients with cancer, therefore methylation serves as a highly reliable tool to confirm cancer presence, in stark contrast with identifying genetic mutations, which may be random.

The IvyGeneCORE test analyzes methylation ratios at specific gene targets to confirm the presence of cancer. Those gene targets were identified through AI and Next Generation Sequencing technology, which decoded the human genome to produce specific gene targets for analysis. The IvyGene technology analyzes only those specific gene targets.In a trial, the IvyGeneCORE test produced a sensitivity of 84% and specificity of 90% on both cancer and healthy patients.

Other biomarkers produced sensitivities ranging from 21-80% sensitivity and specificity ranging from 60-77%. Based on results of the CEA, CA-125, and PSA.

Result Interpretation

Consult with the ordering medical provider about the Ivygene results. Patients with an elevated result may be at an increased risk for cancer at the time of testing.