Genetic Technologies Provides Update on US Operations and Payer Engagement

Rhea-AI Summary

Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) reports significant progress in U.S. market operations. The company is engaging with 11 U.S. payer groups, targeting coverage for its geneType Breast Cancer Risk Assessment Test, which could save the U.S. healthcare system $1.4 billion annually. Other highlights include partnerships with 19 Concierge Medicine practices, re-engagement with 1,600 previous customers, and the establishment of a U.S. operations team for EasyDNA product sales. The Melbourne lab has received CLIA certification as a High Complexity Laboratory, facilitating U.S. sample testing.

Positive

• Active engagement with 11 U.S. payer groups, targeting coverage for geneType tests.
• Potential annual savings of $1.4 billion for U.S. payer system from geneType Breast Cancer Risk Assessment Test.
• Partnerships with 19 Concierge Medicine practices underway.
• Re-engaged with 1,600 previous geneType customers.
• Melbourne laboratory received CLIA certification as a High Complexity Laboratory.

Negative

• None.

MELBOURNE, Australia, Sept. 02, 2022 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”, “GENE”), a global leader in guideline driven genomics-based tests in health, wellness and serious disease, is pleased to report excellent commercial progress in the USA strategic operations with the following updates:

Strategic Highlights:

• Active engagement with 11 US payer groups with an initial target list of 30 with coverage in tens of millions of lives
• Engagement with 19 US Concierge Medicine Practices with large volume pricing discussions
• Commercial evaluations underway at 10 US medical/family practices
• Re-engagement with 1,600 previous geneType US customers
• Dr Erika Spaeth, a key presenter at the Precision Medicine Leaders Summit in Boston
• Online ordering of geneType Multi-Risk Test with Telehealth support established
• Melbourne laboratory receives US CLIA certification as a “High Complexity Laboratory”
• African American ethnicity validation and research collaboration with Washington State University well underway
• Establishment of a new US operations team dedicated to EasyDNA product sales
  

The completion of a Budget Impact Model (BIM) by our Boston based consultant, Alva10, has allowed us to identify a target list of some 30 payers. These range from commercial insurers covering millions of lives to smaller employer groups and with the support of the Market Access team at Alva10 we have active discussions with 11 payers. The goal is to establish initial coverage and reimbursement for the geneType Breast Cancer Risk Assessment Tests and the introduce the Multi-Risk test more broadly. The BIM demonstrated that the introduction of geneType for Breast cancer would save the US payer system US$1.4b annually and resulting in a significant improvement in health outcomes for women at elevated risk of developing breast cancer.

In addition, reimbursement and payer coverage will provide GTG with a substantial commercial success. Alva10 is continuing to assist GTG with a market access strategy focussing on engagement with payers. Gaining reimbursement for the breast cancer risk assessment test will also provide a template for the other risk assessment tests in the Multi-Risk portfolio starting with colorectal cancer.

Since the launch of the geneType Multi-Risk test, the US GTG team have reported great commercial progress. The appointment of John Haslet as VP Business Development is accelerating our commercial engagements with newly developed medical practices and Concierge Medicine networks. We are in advanced discussions with two Concierge Medicine networks representing 19 medical centres and the US Team has initiated a reengagement strategy targeting 1,600 previous geneType US customers.

A recent panel discussion at the Precision Medicine Leaders’ Summit in Boston, featuring Dr Erika Spaeth, GENE’s US based Director of Clinical Affairs & Medical Education, and Dr Hannah Mamuszka, CEO of Alva10, provided an excellent opportunity to showcase the importance of understanding the risk of breast cancer beyond BRCA. Importantly the presentation highlighted the need for geneType Breast Cancer Risk Assessment Test as an aid for predicting risk in non-hereditary sporadic breast cancer, which represents 85% of all breast cancers. A video of the panel discussion is available for viewing from the link below.

The acquisition and integration of EasyDNA has provided an ideal opportunity to broaden patient and clinician access to the geneType Multi-Risk Assessment Test. The test is now available with Telehealth support through the EasyDNA website.

GENE’s Melbourne, Australia based laboratory recently received a renewal of its Clinical Laboratory Improvement Act (CLIA) certification as a “High Complexity Laboratory”. GENE’s laboratory is the only CLIA certified “High Complexity Laboratory” in the Southern Hemisphere, enabling GENE to receive, test, report and bill samples from the USA.

GENE’s CEO Simon Morriss, noted “We are very pleased with the commercial progress in the US that has been made so far this year. We have built a strong foundation that the Company is leveraging towards exceptional growth over the near future.”

Outlook

Commenting on the forward outlook, Simon Morriss stated “We are very pleased with the progress made over this quarter in achieving TGA approvals for the Multi-Risk Test. We now have three brands, geneType, EasyDNA and AffinityDNA anchoring future revenues to seize a multi-Billion-dollar market opportunity with the most comprehensive portfolio of testing available for individuals and animals.

Our focus remains on the commercialization opportunities, establishing the centres of excellence with our geneType Hub strategy. Our US plans continue to be focussed on concierge medicine groups and gaining coverage from the US payer system.

Driving revenue growth by leveraging the EasyDNA and AffinityDNA brands with further investment in R&D to enhance our Multi-Risk Test offering continuing to remain at the cutting edge of genetic testing and preventative health.”

Enquiries

Investor Relations
Adrian Mulcahy
Market Eye – Automic Group
M: +61 438 630 422
E: adrian.mulcahy@automicgroup.com.au 

About Genetic Technologies Limited
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The company’s Polygenic Risk Scores (PRS) platform is a proprietary risk stratification platform developed over the past decade integrating clinical and genetic risk delivering actionable outcomes from physicians and individuals. Leading the world in risk prediction in Oncology, Cardiovascular and Metabolic diseases. Genetic Technologies continues to develop a pipeline of risk assessment products. For more information, please visit www.genetype.com

FAQ

What is the latest update on Genetic Technologies Limited's engagement with U.S. payers regarding GENE?

Genetic Technologies is actively engaging with 11 U.S. payer groups, aiming for coverage of its geneType tests, which could significantly impact its commercial success.

How much could the geneType Breast Cancer Risk Assessment Test save the U.S. healthcare system?

The introduction of the geneType Breast Cancer Risk Assessment Test could save the U.S. payer system approximately $1.4 billion annually.

What recent certifications has Genetic Technologies' Melbourne lab received?

GENE's Melbourne lab has received CLIA certification as a High Complexity Laboratory, allowing it to process U.S. samples.

What new developments have occurred in the U.S. operations of Genetic Technologies?

The company has formed a new U.S. operations team dedicated to EasyDNA product sales and has engaged with Concierge Medicine practices for large volume pricing discussions.

What are the future plans for Genetic Technologies Limited in the U.S. market?

The company plans to focus on establishing coverage from the U.S. payer system and continue commercializing its geneType tests, leveraging its partnerships.