NMPA Reviewer’s Opinion on Colorectal Cancer Detection Kit Revealed

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NMPA granted Innovation Approval to the Colorectal Cancer Detection Kit, Combination Detection Kit for KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and FOBT (PCR fluorescent probe method – colloidal gold method), produced by New Horizon Health, on November 11, 2020.

For the NMPA Innovation Device Review Report on the detection kit released on November 2, please email us at ChinaMedDevice.com.

Pre-clinical, Clinical and Risk-benefit Analysis

As NMPA standardize and streamline the review process for fast-track approvals, it is vital for manufacturers to comply with requirements of following items if you have similar detection kit entering China market.

Pre-clinical

  1. main raw material
  2. production technology and reaction system
  3. analytical performance evaluation
  4. Positive predictive value
  5. stability

Clinical

Three parts of clinical studies were conducted:

  1. screen high-risk populations for colorectal cancer, use colonoscopy and/or pathological examination results as the gold standard to evaluate the sensitivity, specificity, and negative predictive value
  2. retrospectively included 419 patients with confirmed colorectal cancer of different stages, 94 patients with other gastrointestinal diseases and other cancer patients and tested them with IVD. Evaluate the sensitivity and specificity with all prospective and retrospective data.
  3. verify the accuracy for detecting KRAS, BMP3/NDRG4 methylation and fecal occult blood.

Risk-benefit Analysis

… …

This year has published 29 innovation & priority review reports. If you are interested in any device with pre-clinical, clinical and risk-benefit assessment information, please email us at ChinaMedDevice.com.

Significance of Colorectal Cancer Detection Kit

Early stage of colorectal cancer has no obvious symptoms. At present, according to the consensus of experts in early diagnosis and screening of colorectal cancer, colonoscopy is recommended for people at high risk of colorectal cancer. Currently, colonoscopy biopsy and pathological examination is the gold standard for the diagnosis of colorectal cancer. However, this examination is an invasive examination with poor patient compliance.

This product is suitable for people aged 40-74 years who are at high risk of colorectal cancer to detect the nucleic acid substances that may be contained in the shedding of intestinal cancerous cells and the hemoglobin that may be latent in the stool samples. However, this is not a replacement for colonoscopy and cannot be used for screening tumors in the general population.

China Med Device provides turnkey solutions for China RA/QA/CRO and commercialization in IVD/CDX Products. If you would like to get more information about China IVD/CDx market approval, please do not hesitate to contact us.

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