NEW YORK – MiRxes, a Singapore-based biotechnology company, is launching a study to identify biomarkers associated with pulmonary hypertension in Asian populations and validate a microRNA-based diagnostic test for early identification and diagnosis of the condition.
MiRxes, the National University Heart Centre, Singapore (NUHCS), and the National Heart Centre Singapore (NHCS) aim to enroll 200 patients in the study, dubbed SPHERE, by the end of 2023. The study will enroll newly diagnosed and existing pulmonary hypertension patients from NUHCS and NHCS, as well as healthy control patients. Participants will have blood collected and tested for miRNA biomarkers.
MiRxes, which develops blood-based miRNA tests for early disease detection, primarily in cancer, recently obtained CE marking for its miRNA biomarker assay for early detection of pulmonary hypertension. The test is the company's first miRNA biomarker assay outside of oncology and will be evaluated as part of the SPHERE study.
"The test, when commercialized, will complement MiRxes' cancer blood test portfolio to provide a comprehensive set of early detection solutions to alleviate the growing clinical and socio-economic burden of devastating diseases such as cancer and cardio-pulmonary diseases," Lihan Zhou, cofounder and CEO of MiRxes, said in a statement.
Researchers plan to present the initial findings of the study in 2024.
The SPHERE study builds on previous research to identify miRNA biomarkers for early detection of pulmonary hypertension but represents one of the first focused on Asian populations, according to MiRxes.
"Pulmonary hypertension studies in our region are sorely lacking compared to the wealth of data generated in the West," Ting Ting Low, an assistant professor and senior consultant in NUHCS's cardiology department and a principal investigator for the SPHERE study, said in a statement. "Singapore's native population is a unique mix of multiple ethnicities and genetic diversity. It is therefore imperative that we invest additional work in Singapore with the SPHERE study, to gain insights and discover biomarkers that are pertinent especially to the Southeast Asian population."
The study could potentially help to improve diagnosis and treatment for "both Singapore and the Asian population at large," said Jonathan Yap, a clinical associate professor and consultant in NHCS's cardiology department and co-principal investigator for the SPHERE study.
Pulmonary hypertension is a type of high blood pressure in arteries from the heart to the lungs. Symptoms in the early stages of the disease are nonspecific, such as fatigue and difficulty breathing, which makes it difficult to diagnose. Underlying causes can include some types of congenital heart disease, connective tissue disease, coronary artery disease, liver disease, blood clots to the lungs, and chronic lung diseases, as well as genetics, according to the US Centers for Disease Control and Prevention.
MiRxes was founded in 2014 as a spinoff from Singapore's Agency for Science, Technology, and Research. The company has raised $130 million in venture capital funding, including a recent $77 million Series C funding round that closed last year. The company's Series C round was led by CR-CP Life Science Fund and joined by Rock Springs Capital, EDBI, CCBI, and Keytone Ventures, among other financial institutions in the US, Singapore, China, and Hong Kong.