TAmiRNA’s microRNA-based hepatomiR® kit is worldwide the first approved CE-IVD test to measure microRNA liver biomarkers in human plasma. The new microRNA-based hepatomiR® technology represents a milestone previously restricted to research use only (RUO) testing.
hepatomiR® CE-IVD testing applications
The hepatomiR® CE-IVD kit satisfies urgent clinical need for an easily assessable preoperative test to predict liver function recovery after partial liver resection for the treatment of primary or metastatic liver cancer. This is critical to identify liver tumor patients with high risk of postoperative liver dysfunction, and to plan according risk reduction measures.
The qPCR test enables laboratories to quantify the levels of two liver-enriched miRNAs, hsa-miR-122-5p and hsa-miR-192-5p, as well as hsa-miR-151a-5p in human platelet-poor plasma samples. Based on the qPCR data, the hepatomiR® software application calculates and returns a score (“P-score”), that can be used as a surrogate of liver function. The hepatomiR® P-score ranges between 0 and 1, with higher values associated with poor liver function and increased risk of post-hepatectomy liver failure (PHLF). Together with other clinical information, the hepatomiR® P-score can be useful to assess a patients’ eligibility for surgical removal of liver tumors.
During the performance evaluation, plasma samples from a cohort of 146 patients diagnosed with hepatocellular carcinoma (HCC), cholangiocellular carcinoma, or liver metastases from colorectal carcinoma, who were selected for hepatectomy, were analyzed. Nineteen (19%) percent experienced PHLF. The hepatomiR® P-score achieved a positive predictive value (PPV) of 83% and negative predictive value (NPV) of 85%, exceeding the performance of currently available tests (Starlinger et al. 2019).
Test kit features
The hepatomiR® CE-IVD testing kit enables high throughput, allowing analysis of up to six samples per 96-well or 24 samples per 384-well plate. Efficiency is built into the design, with primer-coated 96- or 384-well plates to reduce hands-on time and technical variability.
The kit will return consistent and accurate results from a sample volume of 200 µL of platelet-poor plasma. Samples can be freshly centrifuged plasma that is analyzed within two hours of blood collection or deep-frozen samples (-70oC or lower).
The included hepatomiR® software application ensures reproducible, fast and simple data analysis, allowing progress from raw data to final results within five minutes.
Starlinger, P., Hackl, H., Pereyra, D., Skalicky, S., Geiger, E., Finsterbusch, M., Tamandl, D., Brostjan, C., Grünberger, T., Hackl, M. and Assinger, A. (2019). Predicting Postoperative Liver Dysfunction Based on Blood‐Derived MicroRNA Signatures. Hepatology, 69(6), pp.2636–2651. doi:10.1002/hep.30572.
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