Molecular diagnostics company Genetic Technologies (ASX: GTG) is piloting its risk assessment test geneType in breast screening centres across the US. The Company is establishing a clinical implementation study with breast imaging centres in New York, Miami and Houston. 

In the US, screening is currently between the ages of 40 and 74. So, the current addressable market for geneType in this scenario is 68 million women. Recruiting these leading breast imaging centres as partners in the study provides a significant opportunity to showcase the efficacy of applying risk assessment to the general population.

This research initiative originates from input provided by influential employer and payer organisations in the US, acknowledging the potential health and economic advantages of prioritising women’s healthcare, particularly in the realm of breast cancer.

It aims to change the currently fragmented care process. By fitting into these imaging centre workflows, this study wants to validate the efficacy of geneType in identifying women at elevated risk of breast cancer. This data will be important in driving broader adoption of risk assessment tests such as geneType to modify breast cancer screening and risk-reduction strategies.

Plus, the pilot initiative integrates software from geneType’s partner, Nest Genomics, to enhance communication between patient’s primary care providers and imaging facilities.

Two leading clinicians involved in the study are Sheldon M. Feldman, MD, FACS, Director of breast cancer services at Montefiore Medical Center and Elizabeth Etkin-Kramer, M.D., FACOG, OB-GYN and assistant professor at Florida International University, founder of Yodeah.org and affiliated with Mount Sinai Medical Center in Miami.

Breast density is a crucial risk factor that can mask early cancer detection. It is also associated with an increased risk of developing cancer. Risk assessment for women at the point of imaging ensures that all women receive appropriate follow-up and surveillance beyond standard screening intervals in accordance with their risk.

In H1 FY24, the Company recorded cash receipts of $3.9 million and launched a digital transformation strategy. A record number of geneType tests were processed, with six times more commercial samples received compared to the prior period. Genetic Tech launched the Hereditary Breast & Ovarian Cancer Risk Assessment Test (HBOC) via an exclusive Santa Monica event for select clinicians.

One of the primary outcomes of this study is to evaluate the impact of geneType on imaging compliance among at-risk populations. By exposing individualised breast cancer risks through the geneType Risk Assessment Test, patients are more likely to adhere to recommended screening protocols. The provision of personalised risk assessments should provide increased awareness among patients, motivating them to prioritise their breast health and adhere to scheduled appointments.

Ultimately, this research aims to bring in a new era of precision medicine in the battle against breast cancer, offering screening and risk mitigation opportunities by identifying more individuals at heightened risk.