Mirxes Employees FDA Breakthrough designation for Gastroclear

Mirxes Corporation USA, a fully-owned subsidiary of Mirxes Pte Ltd, an RNA technology startup headquartered in Singapore, has revealed that their pioneering product, GASTROClearTM, an in vitro diagnostic test utilizing PCR-based technology, designed for the early recognition of gastric (stomach) cancer, has been accorded the distinguished Breakthrough Device Designation by the US Food and Drug Administration (FDA).

Mirxes Employees FDA Breakthrough designation for Gastroclear

Presentation on Gastroclear

 

This development signifies a global milestone as it’s the first instance where three significant achievements have converged: 1) an innovative blood miRNA test, 2) an in vitro diagnostic (IVD) tool aimed at the early detection of gastric cancer, and 3) a molecular in vitro diagnostic assay originating from Southeast Asia, all of which have been awarded the esteemed Breakthrough Device Designation by the US FDA. This recognition is exclusively bestowed upon select medical devices that address unmet necessities and deliver heightened efficacy in treating or diagnosing life-threatening or irreversibly debilitating illnesses like cancer.

Unveiled back in 2019, GASTROClearTM holds the distinction of being the planet’s maiden molecular blood examination devised to spot early signs of gastric cancer, empowering both medical practitioners and patients to take proactive measures well before the manifestation of symptoms. The journey of GASTROClearTM’s development and production spans seven years, nurtured by the collaboration of scientists and physicians from esteemed institutions such as the Agency for Science, Technology, and Research (A*STAR)’s Bioprocessing Technology Institute (BTI), Diagnostics Development Hub (DxD Hub), the Singapore Gastric Cancer Consortium (SGCC), the National University of Singapore (NUS), the National University Hospital (NUH), Tan Tock Seng Hospital (TTSH), and Mirxes.

The Singapore Health Science Authority (HSA) granted its approval to GASTROClearTM in 2019 after a prospective clinical validation encompassing more than 5,200 patients within Singapore. In a more recent development, Mirxes, in partnership with seven academic clinical institutions in China, undertook an extensive prospective clinical trial involving over 9,000 patients to secure the registration of GASTROClearTM with China’s National Medical Product Administration (NMPA). Post the pandemic, Mirxes is actively facilitating access to GASTROClearTM in key Asia Pacific markets while simultaneously exploring collaborations to facilitate its introduction within the United States.

As of now, GASTROClearTM is accessible in Southeast Asian markets including Singapore, Indonesia, Malaysia, and the Philippines.

Decoding Colorectal Cancer: The Power of Gene Expression Analysis in Molecular Subtype Classification

Introduction: Colorectal cancer (CRC) is a prevalent and deadly disease with diverse clinical outcomes and responses to treatment. Traditionally, CRC has been classified based on anatomical and histological features. However, recent advancements in gene expression analysis have revolutionized our understanding of CRC’s molecular landscape, leading to the identification of distinct molecular subtypes. In this blog post, we will explore how gene expression analysis is transforming CRC classification and offering new avenues for precision medicine and targeted therapies.

colorectal cancer 2

Understanding Gene Expression Analysis: Gene expression analysis is a sophisticated molecular technique that allows scientists to measure the activity levels of thousands of genes within CRC tumor samples. This analysis provides valuable insights into the underlying genetic alterations and biological processes that drive tumor growth and progression. RNA sequencing (RNA-seq) is a common method used to profile gene expression, enabling researchers to discover unique gene signatures associated with different CRC subtypes.

Identifying Molecular Subtypes of Colorectal Cancer: Gene expression analysis has revealed several molecular subtypes of CRC, each with distinct characteristics and clinical implications. Some of the notable molecular subtypes include:

  1. Consensus Molecular Subtypes (CMS): The landmark study by Guinney et al. (2015) [1] introduced the Consensus Molecular Subtypes (CMS) classification system. Based on gene expression patterns, CMS identified four subtypes:
    • CMS1: This subtype is characterized by immune activation and microsatellite instability (MSI), offering potential responsiveness to immunotherapies.
    • CMS2: Exhibiting features of epithelial differentiation and chromosomal instability (CIN), CMS2 tumors may respond better to conventional chemotherapy.
    • CMS3: These tumors display metabolic dysregulation and unique gene expression patterns, providing opportunities for targeted therapeutic approaches.
    • CMS4: Rich in stromal infiltration, CMS4 tumors are associated with poor prognosis, highlighting the need for innovative treatment strategies.

Clinical Implications of Molecular Subtype Classification: Gene expression-based molecular subtype classification has significant implications for CRC patients and oncologists:

  1. Personalized Treatment Selection: Identifying the molecular subtype of CRC helps tailor treatment plans to the patient’s specific tumor characteristics. For instance, CMS1 patients may benefit from immunotherapies targeting immune checkpoints, while CMS2 tumors may require different therapeutic strategies [1].
  2. Prognostic Insights: Molecular subtypes are associated with varying clinical outcomes. Understanding the subtype can aid in predicting patient prognosis and guiding treatment decisions for more effective outcomes [4].
  3. Drug Development and Clinical Trials: Gene expression analysis can identify potential therapeutic targets specific to each molecular subtype. This information accelerates the development of targeted therapies, and clinical trials can be designed to evaluate the efficacy of these treatments for specific CRC subtypes [7].

Conclusion: Gene expression analysis has emerged as a powerful tool in molecular subtype classification for colorectal cancer. The Consensus Molecular Subtypes (CMS) system and other studies utilizing RNA sequencing have provided crucial insights into the heterogeneity of CRC. By unraveling the molecular complexities of the disease, gene expression analysis is paving the way for more precise and personalized approaches to CRC diagnosis and treatment. As research in this field continues to evolve, we can expect even more advancements in our understanding of CRC subtypes and the development of novel therapies, ultimately improving patient outcomes and quality of life.

References:

  1. Guinney J, Dienstmann R, Wang X, et al. (2015). The consensus molecular subtypes of colorectal cancer. PLoS Med, 13(12):e1001453. doi: 10.1371/journal.pmed.1001453.
  2. Becht E, de Reyniès A, Giraldo NA, et al. (2016). Immune and stromal classification of colorectal cancer is associated with molecular subtypes and relevant for precision immunotherapy. Clin Cancer Res, 22(16):4057-66. doi: 10.1158/1078-0432.CCR-18-3032.
  3. Cancer Genome Atlas Network (2012). Comprehensive molecular characterization of human colon and rectal cancer. Nature, 487(7407):330-7. doi: 10.1038/nature11252.
  4. Roepman P, Schlicker A, Tabernero J, et al. (2011). Colorectal cancer intrinsic subtypes predict chemotherapy benefit, deficient mismatch repair, and epithelial-to-mesenchymal transition. J Surg Res, 171(2):e165-72. doi: 10.1016/j.jss.2011.06.016.
  5. Zhang B, Wang J, Wang X, et al. (2020). Landscape of immune-related genes in colorectal cancer identified by RNA-seq. BMC Cancer, 20(1):174. doi: 10.1186/s12885-020-07316-z.
  6. Karim ME, Wang X, Ren J, et al. (2022). Computational classification of colorectal cancer molecular subtypes using gene expression data. Comput Biol Med, 140:105409. doi: 10.1016/j.compbiomed.2022.105409.
  7. Wang Y, Jatkoe T, Zhang Y, et al. (2004). Gene expression profiles and molecular markers to predict recurrence of Dukes’ B colon cancer. J Clin Oncol, 22(9):1564-71. doi: 10.1200/JCO.2004.08.186.