geneType multi-test approved for commercial release - TechInvest Magazine Online

Genomics-based tests in health, wellness and serious disease Genetic Technologies Limited’s (ASX: GTG) has reached a major milestone in the commercialisation of its geneType system.

The company’s laboratory in Fitzroy, Melbourne has received simultaneous NATA accreditation and US Centres for Medicare and Medicaid Services (CMS) CLIA-certification enabling the commercial launch of the geneType MultiTest in Australia and the USA, respectively.

Highlights:

• Received simultaneous NATA accreditation & CMS certification for Multi-Test in Australia and USA respectively.
•  Official first phase availability of Multi-Test to Health Care Professionals (HCPs) will occur week commencing 21st February 2022.
• First phase launch to cover risk assessment for six serious diseases including Breast, Colorectal, Prostate, and Ovarian Cancers, Coronary Artery Disease and Type-2 Diabetes covering more than 50% of all serious diseases, all in one test sample.
• Currently over 212,4001 individuals in Australia and 2.9 million individuals in the United States receive a diagnosis related to one of these six diseases annually.
• Protected by a robust family of patents.

This is a major milestone achievement for GTG and reflects the significant dedication and contribution from our team across both Australia and the USA,” CEO Simon Morriss said.

“Gaining accreditation from NATA and CLIA-certification from CMS enables the Company to commercialise a product that has been years in the making and marks a significant turning point for the company.

“There is a substantial market opportunity for this Multi-Test, and we are excited to leverage our expanded sales and marketing platform to bring this product to market. This test will provide a proactive assessment test for patients and clinicians with the aim to improve patient outcomes in the long-term.”

Mr Morriss said receiving NATA accreditation and CLIA-certification for the MultiTest was a critical step in making the Multi-Test available to HCPs.

Multi-Test is a Predictive Panel Risk Assessment Test that covers six common diseases which account for ~50%2 of annual morbidities in the US.

Phase one of the launch will include Breast Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Coronary Artery Disease and Type-2 Diabetes with additional disease candidates to follow.

GTG has engaged contract sales teams in Australia and the USA to promote the Multi-Test directly to HCPs.

The Multi-Test represents an important step towards the development of personalised, preventative healthcare, enabling patients and their healthcare professional to develop a long-term health plan.

Mr Morriss said GTG’s commitment to providing integrated risk tests such as the Multi-Test builds on the foundation of the rapidly expanding area of Precision Medicine, which in 2021 was worth US$264 billion in North America annually.

This segment of medicine provides a precise pathway to medical care with a potentially significant improvement in health outcomes for patients.

https://www.gtglabs.com/