Diagnostic Products for Hospital and Clinical Laboratories
Since 2019, MiRXES has successfully launched two in vitro diagnostic (IVD) applications (GASTROClear and Fortitude Kit) to help medical professionals diagnose diseases early.
These game-changing clinical applications are powered by MiRXES’ patented RNA detection technology platform and our know-how and capabilities in R&D and manufacturing.
These diagnostic products make it possible to detect stomach cancer and COVID-19 early so that patients can receive timely, life-saving treatment.
SARS-CoV-2 RT-PCR test for COVID-19
The Fortitude Kit 2.0, which detects the SARS-CoV-2 virus with high accuracy using a 1-step real time RT-PCR process, was developed within 3 weeks in January 2020 by researchers at Singapore’s Agency for Science, Technology and Research (A*STAR) and Tan Tock Seng Hospital (TTSH). The Singapore Diagnostics Development (DxD) Hub carried out the initial production of 15,000 test kits, of which 5,000 were sent to local public hospitals while 10,000 were sent to China to help contain the outbreak.
The technology was licensed and transferred to MiRXES for mass production in early February 2020. MiRXES obtained Provisional Authorization for the Fortitude Kit from Singapore’s Health Sciences Authority (HSA) in March 2020 and is now a legal product owner. MiRXES initially produced 100,000 tests per week but has since ramped up production to more than 300,000 tests a week in response to local and global demand.
To date, the Fortitude Kit has been deployed in 13 Singapore hospitals and labs, public and private, and more than 20 countries internationally. It has been procured by agencies and healthcare institutions around the world, including those in Hong Kong, New Zealand, and the United States. Batches of Fortitude Kit were also part of the medical supplies donated by the Singapore Government to countries including Brunei, Indonesia, Myanmar and the Philippines.
microRNA blood test for stomach cancer
GASTROClear is the world’s first microRNA-based blood test for early detection of gastric cancer that is approved for commercial use. The test was developed in collaboration with the Singapore Diagnostics Development (DxD) Hub and Singapore Gastric Cancer Consortium, including clinicians and researchers from the National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH) in Singapore.
The test was approved by the Health Sciences Authority (HSA) of Singapore in May 2019 for clinical use as an adjunctive test in conjunction with gastroscopy for detection for gastric cancer. GASTROClear is manufactured in Singapore under the ISO13485 quality management system and received CE-Mark in 2017.
GASTROClear’s performance in detecting gastric cancer, included those in the early stage (stage 1-2), has been validated in a prospective clinical study of more than 5000 subjects in Singapore. Doctors and clinics in Singapore can order the test through Tan Tock Seng Hospital’s Molecular Diagnostic Laboratory (TTSH MDL) or through our appointed distributor Innovative Diagnostics Pte Ltd (IDPL).
The world's first
microRNA blood test for early detection of stomach cancer.
Detects early stomach cancer
(stage 0 – 2) with high accuracy.
CE-marked. Manufactured under ISO13485.