Collaborative study between MiRXES Pte Ltd and Actelion Pharmaceuticals Ltd reveals microRNA (miRNA) biomarker signatures have the potential to develop into early identification and diagnosis of early stage pulmonary hypertension (PH).
Currently, the diagnosis of PH is complex and involves the use of medical equipment that require the need for technical expertise. Some methods of diagnosis include, blood tests, chest X-ray, electrocardiogram, echocardiogram, or a more invasive method; right heart catheterization. PH is a serious condition which results from high blood pressure in the blood vessels carrying blood to the lungs.
A more progressive form of PH known as pulmonary arterial hypertension (PAH) takes, on average, two years to diagnose from the onset of symptoms. Many of such patients are diagnosed at an advanced stage of the disease while many others remain unidentified. Delay in diagnosis can prevent early treatment and result in poor patient prognosis, worsening clinical outcomes and survival.
In light of this present challenge, MiRXES Pte Ltd, a Singapore-based diagnostic company and Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson collaborated to examine miRNA biomarker signatures for the detection of PH. This study aimed to assess miRNA-based biomarker signatures in patients in the early stage of the disease, as well as those with established PH using MiRXES’ proprietary assay technology and biomarker discovery platform.
Results of the study were presented at the annual European Respiratory Society (ERS) International Congress in September 2020. In the study, a total of 245 plasma samples were collected from borderline PH, established PH, and non-PH symptomatic patients. All samples were then tested for 600 miRNAs and a routinely used biomarker for PH known as N-terminal pro-brain natriuretic peptide (NTproBNP).
The results also showed that combining miRNA with NTproBNP allows distinguishing of non-PH symptomatic patients from established PH patients.
“The positive results of this study show the potential of miRNA-based diagnostic signatures as a tool to help identify those in the early stages of PH,” said Aaron Waxman, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital, Boston, USA, and Associate Professor of Medicine at Harvard Medical School.
“Assessment of the biomarker N-terminal pro-brain natriuretic peptide (NTproBNP) is routinely used in PH centers today, but this measure is not specific for PH and can be elevated in patients with almost any type of heart disease, making its utility in detecting PH very limited, especially in the early stages.”
These results build upon previous data from an earlier phase of the global research collaboration conducted in the UK and were presented in August 2020 at the American Thoracic Society International Conference. This UK study demonstrated the feasibility of developing miRNA-based diagnostics for early detection of PH.
Building on the data from these studies, Janssen has initiated the CIPHER trial. The CIPHER trial is an ongoing, prospective, multi-centre study that aims to identify miRNA biomarker signatures for early detection of pulmonary hypertension.
“We are very excited with the promising early PH miRNA biomarker data generated from the current studies. Having launched our first regulatory-approved blood-based miRNA oncology test in 2019, MiRXES is committed to leveraging our end-to-end in-vitro diagnostic (IVD) test development and manufacturing capabilities to support the translation of the PH miRNA biomarker signatures from bench to bedside,” said Lihan Zhou, Ph.D., CEO of MiRXES Pte Ltd.
Additional clinical studies are being planned in Asia, starting with Singapore and Japan, to provide further evidence to support the development and validation of the miRNA-based diagnostic test for early identification and diagnosis of PH.