NEW YORK – Australian biotech Genetic Technologies is in talks with private payors in the US and Australia to obtain reimbursement for its polygenic and clinical risk factor test, GeneType.
The test, consisting of a custom Illumina microarray and bioinformatics analysis pipeline, combines clinical risk factors such as imaging and medical history with cross-ancestry polygenic risk scores into personalized risk assessments for nine diseases. It is currently available as a consumer-initiated test in the US and Australia, but is not yet reimbursed.
"We're looking at getting coverage from employers and insurers," said Simon Morriss, CEO of the Melbourne-based firm. He added that the company is not currently seeking reimbursement from Medicare or Medicaid due to the lengthy process involved.
The plan is roughly equivalent in Australia, where the company is focusing on obtaining reimbursement through corporate health plans, large independent doctor networks, and private physicians.
Morriss described GeneType as a consumer-initiated test, meaning that although individual consumers can order it for themselves, the results are analyzed and delivered by a physician, who guides the patient through them via telehealth.
In order to access the US market, Genetic Technologies contracted with market access firm Alva10 to create a health and economic model to show payors the impact of using GeneType to stratify their patient populations and provide supplemental screening to those deemed high risk.
"It's important to carefully identify and focus on narrow intended populations where greater health benefits are observed through PRS testing," said Giordano Bottà, CEO of Allelica, a personal genomics company that also offers various PRS tests.
"Detailed health economics studies are also key in demonstrating to payors the impact of using PRS to change clinical management in individuals at high risk," he added.
Allelica, whose PRS tests target women's health, breast and prostate cancer, and cardiac disease, is also seeking private reimbursement, without ruling out the possibility of public payor reimbursement down the road.
"We are starting by collaborating with private companies who have already built internal teams to evaluate PRS-based tests for reimbursement," Bottà said.
Morriss said that Genetic Technologies is now in talks with 10 "very large payors" and anticipates two or three commercial pilots within the coming three months or so.
In advance of any commercial pilot studies, Genetic Technologies has been conducting validation studies of GeneType in the indications for which it is commercialized.
Last month, for instance, the company published a validation study in the journal Epidemiology of its breast cancer risk model, BRISK, which factors in polygenic risk, mammographic density, and clinical factors.
In that study, BRISK performed equivalently to the similar, simplified Rosner model and outperformed the commonly used Gail and IBIS clinical breast cancer risk models in estimating lifetime breast cancer risk for participants in the nested case-control Nurses' Health Study.
Importantly, the study's results suggested that had women with stage II and higher breast cancer been assessed via GeneType, they might have received their cancer diagnoses at earlier stages.
Based on data from this study and the budget impact model created by Alva10, Genetic Technologies estimates that it could save the US healthcare system approximately $1.4 billion in breast cancer treatment costs annually.
"We try to get everything peer-reviewed [and] published," Morriss said, adding that the company currently has studies for its prostate cancer, pancreatic cancer, and melanoma models under review.
The company has published validation studies of its testing platform for colorectal cancer and type 2 diabetes in PLOS One, and for ovarian cancer in the European Journal of Cancer Prevention.
Genetic Technologies envisions that US sales will account for between 70 and 80 percent of total sales, owing to the greater payor market size, relative to Australia.
For now, all samples are sent to the company's laboratory in Melbourne, which has both US CLIA and Australian National Association of Testing Authorities (NATA) certifications. As the firm builds scale, however, Morriss noted that it has a relationship with a Houston-based service laboratory that has 10 times the test processing capacity. Genetic Technologies expects to begin processing tests there within the next three months as commercial pilot studies become active.
Within Australia, Genetic Technologies has a supply agreement in place with Qiagen with which it plans to build a comprehensive breast and ovarian cancer test, which can be eligible for reimbursement due to the inclusion of BRCA variant testing. The agreement grants Genetic Technologies favorable terms on reagents and access to equipment and bioinformatics capabilities that facilitate combining the two tests into a single collection device.
"Qiagen's enabling us to be able to do that at a cost where we can put both of the tests together and make some money off the reimbursement," Morriss said.
As a single disease test, GeneType is currently paid out of pocket in Australia for approximately A$350 (approximately US$232).
The price is similar in the US but the company can offer it at a reduced rate to customers who pay upfront, resulting in costs of approximately $199 for a single disease and $299 for a complete panel.
"So there's an incentive for the consumer to pay right upfront," Morriss said.
The company is also looking to expand into Southeast Asia and China, the United Arab Emirates, Indonesia, and India. Morriss noted that the firm will have to establish another on-the-ground laboratory in China as that country currently prohibits sending samples outside its borders.
Genetic Technologies expects to soon add a mental health pharmacogenomics PRS test to the GeneType suite, raising the total number of tests on offer to 10.
In contrast to its other tests, which were developed in-house, this test is being licensed from Israeli personalized medicine company Taliaz. The firm expects to make that test available in Australia toward the end of the year. Genetic Technologies will not market the mental health test in the US, as Taliaz has already licensed it to another party there.
In February, Genetic Technologies entered into investor agreements to raise A$5 million (US$3.5 million) by a direct stock offering.