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13d
Population-based screening for colorectal cancer in Wuhan, China. (PubMed)
In conclusion, preliminary real-world evidence suggested that fecal DNA tests had promising diagnostic yield in population-based CRC screening. https://www.chictr.org.cn/showproj.html?proj=192838, identifier ChiCTR2300070520.
Journal
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COLOTECT™ 1.0
7ms
BGI Genomics launches ISO 15189 certified lab in Brunei (BGI Group Press Release)
"Brunei Darussalam's healthcare landscape achieved another significant feat with the launch of the Borneo Genomics Innovation Sdn Bhd (BGIB) Molecular Testing Lab on August 16, 2023, a state-of-the-art laboratory offering invasive prenatal testing, screening for Down syndrome, detection of human papillomavirus (HPV) and COLOTECT, a non-invasive method of screening for colorectal cancer."
Launch • Regulatory
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COLOTECT™ 1.0
8ms
A large-scale real-world study for colorectal cancer screening (ESMO 2023)
Compared to a national CRC program implemented in Hubei Province between 2018 and 2019 using fecal immunochemical tests and CRC risk assessment questionnaires, current program showed a lower initial positive rate (4.4% vs. 17.4%), higher PPVs for CRC (1.3% vs. 0.08%) in the age-matched group, and a higher adherence rate for colonoscopy (71.3% vs. 18.2%). Conclusions Preliminary prospective evidence suggested that fecal DNA tests had promising diagnostic yield in population-based CRC screening, outperforming FIT/risk assessment questionnaire-based screening strategy.
Real-world evidence • Clinical • Real-world
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ADHFE1 (Alcohol Dehydrogenase Iron Containing 1) • PPP2R5C (Protein Phosphatase 2 Regulatory Subunit B'Gamma) • SDC2 (Syndecan 2)
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COLOTECT™ 1.0
10ms
COLOTECT DNA Methylation Detection Kit granted Australian Register of Therapeutic Goods Approval (BGI Group Press Release)
"BGI Genomics is pleased to announce that its proprietary COLOTECT DNA methylation-based test DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C GENES (Real-time PCR) has been listed on the Australian Register of Therapeutic Goods (ARTG) from Australia’s regulatory authority Therapeutic Goods Administration (TGA)."
Non-US regulatory
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COLOTECT™ 1.0
10ms
COLOTECT™ 1.0 awarded MDA certificate in Malaysia (BGI Group Press Release)
"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, Stool Sample Collection Kit have received market authorization from Malaysia's Medical Device Authority...With this certification, COLOTECT™ 1.0 is now available in over six countries/regions and markets that recognize these certificates."
Non-US regulatory
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COLOTECT™ 1.0
12ms
BGI Genomics partners with Zentya to launch fecal DNA test for colorectal cancer in Slovakia (BGI Group Press Release)
"BGI Genomics is pleased to announce the launch of COLOTECT 1.0 in Slovakia, in collaboration with its local partner, Zentya...COLOTECT 1.0 is one of the first-ever fecal DNA tests for colorectal cancer that is available in the country. It is a non-invasive fecal DNA test developed by BGI Genomics for detecting colorectal cancer and precancerous lesions. It uses multiplex methylation-specific PCR (MSP) technology to trace abnormal colorectal cancer DNA-methylation biomarkers from fecal samples."
Launch non-US
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COLOTECT™ 1.0