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8ms
Illumina to pay $325M under settlement with BGI affiliates, ending multifront US legal battle (Genomeweb)
"Illumina said on Thursday that it has reached a settlement and licensing agreement with China's BGI and its affiliates, including MGI Tech, that will end the multi-year legal battle between the two sequencing firms in the US...The settlement ends all outstanding litigation, including at least four lawsuits in US district courts and four pending appeals in the US Court of Appeals for the Federal Circuit, concerning patent infringement and antitrust allegations."
Corporate lawsuit • Patent
9ms
BGI’s Homologous Recombination Deficiency Detection Kit receives CE-IVDD certification (BGI Group Press Release)
"BGI announces that its Homologous Recombination Deficiency Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) has recently obtained CE-IVDD approval...This kit is developed for the qualitative detection of genomic homologous recombination deficiency (HRD) based on high-throughput sequencing technology, and adopts the combinatorial probe-anchor synthesis sequencing method."
European regulatory
1year
BGI’s DNA methylation detection kit gets Thailand’s TFDA Medical Device Import License (BGI Group Press Release)
"BGI’s DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-time PCR) obtains the Medical Device Import License of Thailand Food and Drug Administration...The detection kit will bring significant implications for CRC prevention in Thailand and reduce the occurrence of related diseases."
Non-US regulatory
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DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C
1year
BGI obtains SFDA approval for its gene annotation software and detection kit on non-small cell lung cancer (BGI Group Press Release)
"BGI Genomics announces that its Non-small Cell Lung Cancer Mutation Analysis Software and EGFR/KRAS/ALK Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) have been approved by the Saudi Food and Drug Authority (SFDA)...BGI’s mutation analysis software and detection kit offer a comprehensive solution for detecting NSCLC, allowing clinicians to diagnose timely and provide patients with effective treatment options."
Non-US regulatory
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EGFR/KRAS/ALK Gene Mutation Detection Kit
1year
BGI’s colorectal cancer detection kit gets SFDA approval (BGI Group Press Release)
"BGI Genomics announces that its DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C Genes (Real-Time PCR) has been certified by the Saudi Food and Drug Authority (SFDA)...The SFDA approval marks BGI’s commitment to the advocacy of cancer screening and early detection in Saudi Arabia and the entire Middle East."
Non-US regulatory
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DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C
1year
BGI has obtained CE Mark for its lung cancer and pan-cancer detection kits (BGI Group Press Release)
"BGI Genomics Co. LTD...announces that its Lung Cancer Library Reagent - Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method), and Pan-Cancer Library Reagent - Solid Tumor Multi-gene Combined Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) have got the CE mark in December 2021."
European regulatory
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Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit • Solid Tumor Multi-gene Combined Detection Kit
over1year
BGI’s three complementary kits of colorectal cancer testing have been CE Marked (BGI Group Press Release)
"BGI Genomics announces that its Stool Sample Collection Kit, DNA Isolation Kit together with Sample Pretreatment Kit for Methylation Detection have been CE marked. All three kits are used in conjunction with the previously CE marked Colorectal Cancer Testing Product which can detect the methylation of SDC2, ADHFE1 and PPP2R5C genes in human fecal samples."
European regulatory
over1year
Natera and BGI Genomics announce commercial launch of the BGI/Natera Signatera assay in China (Natera Press Release)
"Natera, Inc...and BGI Genomics Co., Ltd...today announced the launch of the BGI/Natera Signatera Assay which is now available to biopharmaceutical customers and clinicians across China...Natera’s Signatera® assay, now offered in partnership with BGI,1 has been utilized in numerous clinical studies across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease (MRD) up to two years earlier than standard imaging. The test is now available in China under the Chinese brand name "Tumor MRD Customized Detection (HuaJianWei® for short)."
Launch non-US
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Signatera™
almost2years
BGI gets CE mark for colorectal cancer testing kit (BGI Group Press Release)
"BGI Genomics today announces that the DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR) has been CE marked. The kit can detect the methylation of SDC2, ADHFE1 and PPP2R5C genes in human fecal samples."
European regulatory
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DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C