NEW YORK – Genetron Health is preparing for a major expansion to its test menu this year with the awaited launch of a personalized minimal residual disease (MRD) assay for solid tumors.
Meanwhile, the firm is readying a pivotal trial intended to support regulatory approval for an IVD kit version of its liver cancer screening test, and eyeing new opportunities that would extend its development runway into even more markets.
During a call discussing the firm's 2021 financial results, Genetron Chairman and CEO Sizhen Wang said that the company has two new products in development: a liquid biopsy genomic profiling panel for which the firm provided few details and a PCR-based molecular classification test for thyroid cancer called Thyroid Basic.
At last year's annual European Society of Medical Oncology congress, Genetron shared data from a small cohort that suggests its test could help predict the cytopathology rating results from repeated fine-needle aspirate (FNA) biopsies, assisting with clinical pathology classification and potentially enabling patients to receive better clinical treatment at an earlier stage.
Researchers reported that 10 of 11 patients with positive molecular test results after an initial FNA biopsy had an elevated BSRTC rating when subsequent FNAs were later performed. Such patients could potentially undergo surgical treatment immediately after molecular detection, instead of suffering repeated FNA biopsies.
According to Wang, China sees more than 220,000 new thyroid cancer incidences per year. "We're currently conducting a registrational trial ... at four clinical sites, and we anticipate completing the trial in 2022 with potential IVD approval next year," he said.
Genetron CFO Evan Xu added that the test should be "easily distributed" across the broad PCR infrastructure in China that has emerged in "lower-tier cities."
In the meantime, Genetron is on the cusp of another major launch — of its tumor-informed MRD assay. The current plan is for an initial pilot launch in the second quarter and an expanded launch before the end of the year, Wang said.
The tests are akin to other personalized MRD strategies taken by US companies like Natera, and by Genetron's competitor in China, Burning Rock. Wang said that Genetron's mutation capsule technology has yielded strong analytical validation results when applied to MRD.
In a gastric cancer study published last year in the Journal of Hematology and Oncology, the firm's personalized assays were able to detect tumor DNA at a .001 percent allele frequency in cell pellets extracted from peritoneal lavage fluid samples.
"In a prospective cohort of 104 gastric cancer patients, the MRD assay detected all the cases that developed peritoneal dissemination with 100 percent sensitivity and 85 percent specificity. MRD-positive patients [also had] decreased recurrence-free survival and overall survival," Wang said.
More recently, the company published data in the Lancet-associated journal EBioMedicine from a study of locally advanced rectal cancer patients after neoadjuvant chemotherapy. Another similar study focused on hepatocellular carcinoma has been accepted by a high-impact journal, Wang said, and should publish within the next few months.
He added that the next step will be to validate its tumor-informed MRD approach in a larger sample set, and start a prospective study, potentially sometime this year.
Genetron is engaged in a multi-year codevelopment agreement with AstraZeneca for its MRD testing in China, which was announced late last year. "Both the AZ and Genetron teams have been working together very diligently since the partnership started," Wang said. "Assay optimization is currently ongoing and expected to finish by years end."
Under the partnership, AstraZeneca plans to use the codeveloped MRD test for China-specific solid tumor clinical trials designed to incorporate the use of personalized MRD tests. The companies may also expand the partnership in the future to include IVD registration and commercialization activities.
MRD aside, Genetron is also approaching a major milestone for its early cancer detection technology as this year progresses. The company initiated a planned 5,000-patient registrational trial last November, intended to support approval by China's National Medical Products Administration for its multi-marker, PCR-based methylation assay for hepatocellular carcinoma early detection, HCCscan.
Wang said this week that Genetron has begun patient accrual in five of nine planned sites, some of which will also participate in a similar trial for the firm's broader multiomics version of the test, called HCCscreen.
"The HCCscreen [study] has been slightly delayed based on COVID-related disruptions. But we do plan to enroll subjects around the end of the second quarter," Wang said.
"We continue to believe that this structure of both PCR and NGS tests is a sound strategy. PCR has a more established presence and readily available workflows in many hospitals and clinics in China. And that trend continues to accelerate," he added. "Adding a high-performing PCR based asset would be commercially viable, while also providing self-pay patients … with a cost-optimal solution."
According to Xu, Genetron is actively working with provincial government bodies to try to inform the development of future reimbursement policies for NGS-based cancer assays like the broader HCCscreen test. "Right now, there are very few price points to refer to given this is kind of a new type of molecular testing," he said.
"With [these] efforts and also with the increasing clinical adoption of our assay, we do feel that we have a good chance in the next 12 to 24 months, in some regions … to be eventually reimbursed."
Xu added that it's premature to project the future market split between HCCscan and HCCscreen, but he said the "overall idea" is that "combining these two products, we will be able to actually penetrate the market quicker, given that the two assays will be positioned differently and priced differently."
For the US market, Genetron has begun a complementary study with what it said are two leading medical institutions, with early data possibly being presented at upcoming scientific meetings.
Beyond liver cancer, the firm is also cementing plans to eventually develop a multi-cancer product in the future. "We have already shared some early retrospective colorectal cancer results … showing over 91 percent sensitivity and 95 percent specificity, [and] we continue to expect the CRC data to be published sometime in 2022," Wang said.