NEW YORK – Although most of the clinical testing and biopharma services Genetron Health currently provides are in the area of advanced cancer genotyping, the firm said this week that its eye is firmly on liquid biopsy testing, especially for early cancer detection and monitoring, as it maps out future technology and commercial development plans for both China and the US.
The Beijing-based precision oncology firm has clinical testing labs in several Chinese cities through which it currently markets a wide variety of genomic research and clinical genomic testing services, including whole-genome sequencing and targeted panels for tumor tissue genotyping, advanced cancer liquid biopsy, and germline genetic testing.
More recently, the company has branched out with the development and commercialization of new cancer screening and minimal residual disease test technologies. Genetron executives said this week that the firm plans to expand significantly in both areas in coming years.
"Our strategic focus going forward will be to accelerate the development of liquid biopsy-based solutions across the full cycle of cancer management, particularly in early screening and MRD … and we are committed to bringing these innovative products to patients fast," Genetron cofounder and CEO Sizhen Wang said during a call with investors this week to discuss the company's Q3 financial results.
The firm's first test in this area is a liver cancer screening assay called HCCscreen. Last month, it also licenced an MRD technology called Seq-MRD for the detection and monitoring of minimal residual disease in select hematologic cancers from ImmuQuad Biotechnologies.
Last year, Genetron published data from a prospective study of HCCscreen, a combined circulating cell-free DNA and protein liquid biopsy assay that identifies individuals with incipient virus-associated liver cancer. In the study, researchers from the Chinese Academy of Medical Sciences working with Genetron followed more than 300 individuals with hepatitis B who had normal liver ultrasonography and serum alpha fetoprotein (AFP) levels to see if the company's test could identify those who would go on to be diagnosed with hepatocellular carcinoma (HCC).
According to the authors, the test demonstrated 100 percent sensitivity and 94 percent specificity at the time of the study endpoint.
Genetron already offers the test as an LDT in China, where it is contributing on a small scale to the company's revenues.
According to Wang, the firm hopes to roll the test out further over the coming year, both to current users and through new government procurement contracts it has been working on. "We do believe these commercialization efforts will become bigger and bigger revenue drivers, especially heading into next year," he said.
The firm has five labs in China, including one in Beijing that is both CAP and CLIA certified, Wang said, and its first roll-out efforts have been with a leading local medical network.
"The COVID-19 pandemic has undoubtedly caused some delays in our collaboration and roll-out efforts, but we expect the partnership could become more productive over the next few quarters, and we are currently [also] rolling out HCCscreen through government procurement contracts," he added.
Such contracts "not only bring revenues [but] can also serve as a development model down the road to local government adoption and reimbursement," Wang said.
Genetron's prior prospective analysis of HCCscreen utilized data from a subset of patients in an ongoing study of 2,000 high-risk individuals, and the firm is expecting to release data from the full cohort by early next year, Wand said.
If the results hew closely to the sensitivity and specificity it saw in the smaller sub-cohort, the company plans to launch a registrational trial following an additional 2,500 individuals, which would support a bid for regulatory approval in China, and then potentially in the US.
The US Food and Drug Administration granted Genetron breakthrough device designation for HCCscreen at the end of September. "Our next step is to work out a detailed development plan with FDA, followed by further test validation and a potential filing of investigation device exemption for a US clinical trial," Wang said.
"In conjunction with this, we are currently building a lab in Gaithersburg, Maryland, [for] which we intend to pursue CLIA certification. This lab will be used to facilitate US trials for HCCscreen as well as to serve global pharmaceutical companies. We expect the lab should be ready in a few months," he added.
As genomic cancer early detection efforts have rapidly expanded in recent years, several other firms have also targeted HCC. These include the Laboratory of Advanced Medicine's IvyGene, Chinese firm SeekIn, and Exact Sciences. Others, like Grail and Thrive Earlier Detection, are taking a pan-cancer route with tests that would screen for multiple tumor types, potentially including HCC.
Several of these firms, including Grail, Exact Sciences, and Helio Health, have also garnered FDA breakthrough designation for their assays over the last year.
According to Wang, Genetron believes it will have the best success with a strategy that focuses first on early detection assays that offer optimal performance for individual cancer types before working to combine these into a multi-cancer screening product.
Beyond HCCscreen, the firm is also working on screening tests for lung and digestive cancers, most notably through a national research project for early screening of these cancer types led by China's Ministry of Science and Technology.
Wang said that this program is using Genetron's mutation capture technology and will eventually include a multicenter prospective cohort study in lung cancer that will target over 120,000 high-risk individuals across 20 Chinese provinces, and a digestive system cancer detection cohort of more than 100,000 patients in urban areas in China.
The firm has also been conducting internal research targeting colorectal cancer, with data expected in 2021. Like liver cancer, colorectal cancer is also a prime target for many potential competitors, including Exact Sciences, Freenome, Guardant Health, and Singlera.
Regarding minimal residual disease testing, Wang said that Genetron is now working to expand its capability beyond the current hematologic cancers that Seq-MRD is designed to address, beginning with the same solid tumors it has targeted for early detection: liver and colorectal cancer.
"MRD for solid tumor is a program that we are going to put a lot of resources into," he said. "And what I can tell you now is that … through our preliminary research projects we have had in the past year or so, we've got some good preliminary data for the liver cancer MRD, and we will be expanding that study to a bigger cohort partnering with several institutions in in China and potentially in the US, as well."
In addition, the firm will put efforts into developing a colorectal cancer MRD, which it plans to develop jointly with its CRC early screening test, he said.