COLOTECT 1.0 has obtained the MDA certificate in Malaysia

Colorectal cancer progression

image: Colorectal cancer progression
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Credit: BGI Genomics

Recently, BGI Genomics’ COLOTECT™ 1.0 DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-time PCR), Sample Pretreatment Kit for Methylation Detection, DNA Isolation Kit , the stool sample collection kit has received marketing authorization from the Malaysian medical device authority (hereafter MDA).

With this certification, COLOTECT™ 1.0 is now available in over six countries/regions and markets that recognize these certificates. COLOTECT™ 1.0 is eligible for EU market entry and has obtained MDMA in Saudi Arabia, MHRA Registration in UK, TFDA Certification in Thailand, ANVISA Certification in Brazil, Listing Certificate in Hong Kong and ARTG Certificate in Australia. This flagship oncology product will help accelerate the growth of the company’s international business.

COLOTECT™ 1.0 is a non-invasive and highly sensitive test for colorectal cancer (CRC) and precancerous lesions. Users could perform this test at home to provide fecal samples for specific multi-methylation PCR to detect abnormal CRC gene markers. Detecting the methylation status of exfoliated cell genes in the intestine helps detect colorectal cancer and the risk of precancerous lesions and the risk of colorectal cancer, even without active bleeding lesions.

Colorectal cancer is the third most common cancer and the second deadliest cancer globally. It is estimated that. In 2020, there were approximately 1.9 million colorectal cancer diagnoses worldwide. Older age, a history of intestinal disease, a family history of related conditions, type 2 diabetes, being overweight or obese, certain types of diet, smoking and alcohol consumption are all risk factors that can lead to colorectal cancer. The incidence rate of colorectal cancer among young people has also increased significantly in recent years.

However, colorectal cancer usually does not show any symptoms in the early stages, resulting in nearly 50% of patients not being detected until they reach stage 3 or 4 and miss the best time for treatment. treatment. If colorectal cancer is diagnosed at an early stage, the 5-year relative survival rate of patients can reach 90%. Conversely, if it is stage IV at the time of discovery, the 5-year survival rate will be reduced to only about 10%.

According to the National Colorectal Cancer (Opportunistic) Screening Program in Malaysia. From 2014 to 2018, 127,957 people in Malaysia underwent immunoassay screening for fecal occult blood or iFOBT, of which 9.3% were positive for iFOBT and recommended colorectal surgery. 6,548 people in Malaysia eventually underwent colonoscopy, 13.9% found polyps in the colon, with only 266 (4.1%) diagnosed with colorectal cancer.

iFOBT screening problems include lack of awareness regarding CRC screening, the embarrassment of collecting stool samples, and people who have tested positive but missed the diagnosis. There are also problems related to poor colonoscopy access and lack of monitoring and follow-up.

The advantages of the COLOTECT™ 1.0 product are:

  1. Convenient: Autosampling at home. No special preparation or downtime required.
  2. Effective – Highly sensitive. Accuracy of 87% of CRC and 42.1% of advanced adenoma.
  3. Accurate: specificity reaches 93%.
  4. Total Solution: Provides a complete set of sampling, processing and testing kits.
  5. Simple workflow: Only a small one-time sample is required.
  6. High Quality – Strict quality control measures; ISO 13485 certified manufacturer.

Over the years, BGI Genomics has invested in oncology research and clinical transformation. In the future, the company will expand its research in this area, launch more personalized services, and develop related test reagents to contribute to precision medicine and safeguard public health.

About BGI Genomics

BGI Genomics, headquartered in Shenzhen, China, is the world’s leading provider of integrated solutions for precision medicine. Our services cover more than 100 countries and regions, involving more than 2,300 medical institutions. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.


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