NEW YORK ─ Two years after the launch of its first microRNA-based cancer screening assay, MiRxes is looking to expand and diversify its product portfolio with additional PCR tests for cancers and the early detection of cardiovascular, metabolic, and infectious diseases.
On the back of a recent Series C financing round, MiRxes is developing assays for breast, colorectal, liver, ovarian, and pancreatic cancers that use disease biomarkers revealed during its own discovery process, said Lihan Zhou, the firm's cofounder and CEO.
Eventually, Zhou added, the company expects to launch an miRNA-based multi-cancer screening system that could be used by hospital laboratories primarily in the US, Japan, China, and Singapore with necessary regulatory clearances.
"Our multi-cancer screening strategy involves approaching each cancer individually because it is easier to plan clinical studies and obtain approval for one cancer at a time," he said. "But, from a laboratory testing and health screening perspective, it will be entirely possible to conduct testing for all of these cancers from a single draw."
The company’s blood-based miRNA assays require only 200 microliters of serum or plasma, he noted. Although its commercial test — a gastric cancer screening test called GastroClear — and those furthest along in its pipeline use patient blood samples, the company has also completed biomarker discovery on urine and tissue samples for cancer screening, and plans to use the most suitable sample type for each disease.
"In most cases, we are looking at a combination of eight to 12 microRNA markers to screen for a specific disease," Zhou said.
In 2019, the company launched GastroClear, which measures 12 microRNAs in serum to detect gastric cancer, also known as stomach cancer. The company validated its test on Thermo Fisher Scientific's QuantStudio Dx Real-Time Instrument, but the assay works on any RT-PCR system. Using one qPCR machine, a lab can run 13 gastric cancer tests in three hours, the firm said.
Laboratories in Singapore are running the gastric cancer screening test on the back of MiRxes' receipt of regulatory approval from Singapore's Health Sciences Authority in 2019 and CE marking in 2017.
The firm is focused on launching the test throughout Asia, Zhou said, where gastric cancers have a high prevalence. In early 2022, MiRxes intends to launch a 12,000-patient prospective clinical trial with the aim of seeking registration for GastroClear in China from China’s National Medical Products Administration, and Zhou said it will soon look to obtain regulatory approval for GastroClear as an IVD screening kit from Japan's Pharmaceuticals and Medical Devices Agency.
Prior to the launch of GastroClear in Singapore, clinical investigators there used it to screen 5,248 patients that were part of a high-risk symptomatic population and saw the assay demonstrate 87 percent sensitivity for detecting gastric cancer, including a sensitivity of 87.5 percent for stage I gastric cancer; a specificity of 68.4 percent; and a negative predictive value of 99.5 percent. The investigators published the results of the study in 2020 in the journal Gut.
Zhou said MiRxes expects its next commercial PCR test will detect microRNA biomarkers for lung cancer, and for that, it is conducting a 600-patient validation study. A laboratory-developed test for lung cancer screening is expected to reach the market in Japan next year, and the firm is exploring options for entering the US, he said.
To support the development of its cancer screening tests, the firm has closed a few rounds of financing since its inception, including a seed round of about $3 million in 2016, a $40 million Series A round in 2018, and the recent Series C round, which netted an additional $10 million above the originally expected $77 million, Zhou said.
MiRxes also plans to use the new funding to develop non-oncology miRNA tests, including for cardiovascular, metabolic, and infectious disease diagnostics.
On the back of demand for SARS-CoV-2 testing, the company has already entered the infectious disease testing space. In January, it announced it had received CE marking and provisional authorization from the Singapore Health Sciences Authority for a test kit that combines its real-time PCR Fortitude Kit SARS-CoV-2 test and syndromic panels for influenza A and B. MiRxes said the approved test is being sold in Singapore and it is seeking regulatory approval from Japan's PMDA to sell it there.
To date, the company has deployed about 8 million SARS-CoV-2 tests, Zhou said, adding that the firm expects to see the benefits of greater brand exposure as a result of the infectious disease test sales.
MiRxes intends to position its current and future cancer tests for sale to the same laboratories that are running its SARS-CoV-2 RT-PCR assays, he said, adding that as a result of the COVID-19 pandemic, he believes people are better educated about the benefits of screening and asymptomatic testing for early detection. That could make it easier in the future to place early-detection screening tests for oncology and other disease indications, he added.
MiRxes was spun out from Singapore's Agency for Science, Technology, and Research in 2014 to further develop and commercialize clinical tests for a PCR-based microRNA platform that the agency had developed for research applications.
MiRxes currently employs about 230 people. For marketing and business development, the company uses an internal sales team and distributors.
In Singapore, the company runs operations for R&D, manufacturing, global regulatory affairs, global medical affairs, and global sales and marketing. In the US, Japan, and Europe, the firm has established collaborations with biopharmaceutical and research organizations and has its own facilities to conduct business development. In China, the firm has R&D, manufacturing, clinical diagnostic laboratories, and sales and marketing operations.
Zhou said he and his colleagues published their first paper on the technology underpinning MiRxes’ platform in 2010.
"Overall, our microRNA-based technology and assays can be very good at early detection whether it is for cancer, cardiovascular, or infectious diseases," Zhou said. "But we are also looking across the patient journey and adding other types of biomarkers where appropriate."
For liver cancer screening, the firm is running a prospective clinical study in Singapore, partly funded by the Singapore Ministry of Health, which combines miRNA biomarkers with alpha-fetoprotein and ultrasound for detection. For its ovarian cancer test, the firm has "seen unique synergy by combining microRNA with CA125," Zhou said. Similarly, for its cardiovascular assays in development, the firm is seeing promising early results by combining microRNA biomarkers with anti-proBNP, and for its lung cancer screening test it is seeing the potential of combining microRNA with methylation markers.
For metabolic disease test development, the firm has been conducting studies to discover microRNA biomarkers associated with insulin resistance, which leads to type 2 diabetes, gestational diabetes, and prediabetes. It is currently engaged in biomarker optimization and verification for the insulin resistance test.
Zhou added that the firm believes "in the importance of providing a complete picture of the patient" and is therefore developing tests to aid in therapy selection, treatment response monitoring, and disease recurrence. MiRxes has launched a program related to minimal residual disease detection and therapy selection in Singapore that incorporates next-generation sequencing along with microRNA markers, he said.
The firm is also studying acquisition opportunities in the US and Europe, specifically evaluating companies with complementary technologies and with point-of-care and laboratory testing platforms. MiRxes is also evaluating the potential to purchase clinical laboratories that would run its future tests. Thus far, the firm has been developing its assays to run on Thermo Fisher's PCR platforms, but moving forward, "we want to integrate other laboratory PCR platforms and POCT devices that could be used in general practitioners' offices," Zhou said.