NEW YORK – Beijing-based precision oncology firm Genetron Health expects to see significant progress this year in the commercial rollout of its blood-based liver cancer screening test, HCCScreen, as well as in various research efforts intended to support new regulatory submissions.
The company also expects it will expand its core early detection technology across additional cancer types.
The company announced new results this week from a prospective study, begun in 2019 in collaboration with China's National Cancer Center, analyzing the performance of HCCScreen in carriers of the hepatitis B virus. According to the company, the test has now achieved 88 percent sensitivity and 93 percent specificity across 1,615 HBsAg+ individuals that completed the follow-up phase by February 2021.
Like many other approaches being developed for blood-based cancer early detection, HCCscreen involves the measurement of epigenetic signals, in this case, detection of DNA methylation, which the company couples with mutation detection and other analyses in a technology it calls MutationCapsule.
Prior to the update this week, the most recent data from the firm's prospective study was in a smaller cohort of the earliest enrolled patients, in which test performance was higher — a sensitivity of 100 percent and a specificity of 94 percent in the company's 2019 publication in PNAS — but with much larger confidence intervals than achievable in the new analysis.
Although the test performance has dropped a bit as these confidence intervals have tightened, it is still an improvement over current standard for care, which includes ultrasound and measurement of alpha fetoprotein, or AFP. In the Genetron study, these tools yielded only 71 percent sensitivity and 95 percent specificity.
For the new updated trial data, the company calculated a 40.9 percent positive predictive value and 99.3 percent negative predictive value for HCCscreen. Investigators also broke a subset of the cohort down by tumor size, reporting sensitivity of 85 percent for tumors less than 3 cm and 96 percent for tumors from 3 cm to 5 cm. Performance dropped to 88 percent for tumors larger than 5 cm, but this was most likely a result of there being few such cases in the set used.
Buoyed by the updated results, Genetron is continuing with its plans to initiate a National Medical Products Administration registrational trial, which it now intends to begin within the second quarter of 2021, and which would, if successful, support the agency's IVD approval of HCCscreen.
The firm already offers HCCscreen as an LDT, and during its Q4 and full year 2020 earnings call this week, Genetron CFO Evan Ce Xu predicted that the test could grow to contribute between 10 percent and 15 percent of the company's 2021 revenue.
"Our commercialization efforts started last year when we [outlined] essentially three different channels to educate the market and to commercialize our product," Genetron Cofounder and CEO Sizhen Wang said on the earnings call this Thursday.
These include nabbing government testing contracts, such as its joint venture with the Wuxi government, expanding test provision under its deal with iKang Healthcare Group, and building out a recently announced biopharma co-marketing arrangement with Chia Tai Tianqing Pharmaceutical Group.
"This is now very encouraging results we're getting from our prospective study that we've been working on for almost two years [and] I believe that the data, as well as our upcoming efforts to get into the registrational trial, will allow us to work more closely with our partners to essentially dig deeper into these three different [arms] of commercialization," Wang said.
"We've been very busy training [the iKang] staff in the last year … so with the validation from the prospective study we will be accelerating our commercialization efforts through that channel as well," he added.
The company is also working on establishing a local lab in Wuxi to support its government-sponsored pilot, with the goal of being ready for testing operations there by the end of 2021.
"This pilot model sets a good course for possible future commercialization and reimbursement roadmaps. More importantly, we are generating large scale, real world data from this collaboration, which offers tremendous strategic value as we continue to progress on expanding our early screening pipeline beyond liver cancer," Wang said.
As it tackles this commercial push, Genetron also expects to be able to make significant progress on the research side this year, aiming to eventually translate the technology behind HCCscreen, Wang said, into a platform for simultaneous screening for multiple types of cancer.
According to Wang the company will present data later this year from a case-control colorectal cancer early detection study. Lung cancer is also another accelerating target.
Genetron faces a number of potential competitors, both for HCCscreen specifically, and if the firm is successful in expanding its technology to a multi-cancer application. Although few other firms have shared prospective data for their assays thus far, many have begun their own registrational trials.
For its part, Genetron said that it expects to be able to achieve NMPA approval for HCCscreen by 2023 with its current trial timeline.
The firm has also received a breakthrough device designation for the assay from the US Food and Drug Administration. According to Yun-fu Hu, Genetron's chief medical officer, although things have moved a bit slower for the firm in the US due to the coronavirus pandemic, the company is preparing for its next steps there as well, which will begin with a prospective study in a high-risk local cohort.
"Our lab in Maryland is now CLIA certified, it will be used to facilitate this, as well as to serve global pharmaceutical companies," he said.