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COMPANY:
Amoy Diagnostics

i
Other names: Amoy Diagnostics | Amoy Diagnostics Co., Ltd. | Amoy Diagnostics Co. Ltd. | AmoyDx
Related tests:
Evidence

News

4ms
AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as a companion diagnostic for LUMAKRAS® (Sotorasib) (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA')...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for Amgen’s LUMAKRAS® (sotorasib), for patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
7ms
Investigators present significant research during WCLC 2022 (AmoyDx Press Release)
"Several key researches supported by Amoy Diagnostics were presented at WCLC 2022...EP16.03-033...Structure-based classification of Chinese patients with non-canonical EGFR-mutant Non–Small Cell Lung Cancer..."
Clinical data
7ms
Amoy Diagnostics and Roche Pharma China jointly announce strategic partnership (AmoyDx Press Release)
"Amoy Diagnostics and Roche Pharma China reached a strategic cooperation to jointly promote the development of an open, cooperative and innovative medical and health ecosystem and provide patients with more accurate digital medical solutions. This coupled with the July 29th approval of Roche’s Rozlytrek (Entrectinib, a selective tyrosine kinase inhibitor to treat patients with NTRK-fusions positive solid tumours) in China will allow both companies to work jointly to establish a precise and treatment path and maximize the benefits for NTRK-fusion positive patients."
Licensing / partnership
7ms
AmoyDx® Master Panel--Study reveals clinically relevant intertumoral heterogeneity of NSCLCs driven by MET Exon 14 skipping mutation (AmoyDx Press Release)
"A study presented at the IASLC World Conference on Lung Cancer 2022 in Vienna disclosed the clinically relevant intertumoral heterogeneity of non-small cell lung cancer (NSCLC) driven by MET exon 14 skipping (METex14 skipping)...All the samples were subjected to targeted RNA sequencing using the AmoyDx® Master Panel consisting of 2660 onco-immunology genes."
Clinical data
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AmoyDx® Master Panel
8ms
MHLW approves AmoyDx® Pan Lung Cancer PCR Panel as companion diagnostic for Rozlytrek® (entrectinib) in Japan (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA')...announced that the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') had been approved by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC) for Rozlytrek®...The AmoyDx® PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for eleven associated targeted therapies in NSCLC."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
8ms
Alercell® to distribute Amoydx® ROS1 Gene Fusion Detection Kit (Alercell Press Release)
"Alercell® announced...that it has started the distribution of AmoyDx ROS1 Gene Fusion Detection Kit. Part of the master AmoyDx distribution agreement signed last month...The AmoyDx® ROS1 Gene Fusions Detection Kit is a real-time PCR assay for qualitative detection of 14 ROS1 gene fusions in human total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissues in NSCLC patients."
Licensing / partnership
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AmoyDx® ROS1 Gene Fusions Detection Kit
8ms
Alercell® to distribute Amoy Diagnostics’ molecular cancer tests (Alercell Press Release)
"Alercell® announced today that it has entered into a master distribution agreement with Amoy Diagnostics Co., Ltd (AmoyDx)...The master distribution agreement enables Alercell® to introduce to the United States market several innovative DNA sequencing cancer tests...The first tests to be introduced under the Agreement include: Pan Lung Cancer PCR Panel, EML4-ALK Fusion Gene Detection Kit, BRCA Pro Panel, and the Human Papillomavirus (HPV) Genotyping Detection Kit. These molecular diagnostic tests are all introduced as RUOs (Research Use Only) and are the most advanced next generation DNA sequencing tests in various fields to tackle, Lung Cancer, Breast Cancer , Ovarian Cancer and Cervical Cancer screening."
Licensing / partnership
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AmoyDx® BRCA Pro Panel • AmoyDx® EML4-ALK Fusion Gene Detection Kit • AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit • AmoyDx® Pan Lung Cancer PCR Panel
11ms
Filing notice for a manufacturing and marketing application for AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic for a drug targeting RET fusion-Positive non-small cell lung cancer (AmoyDx Press Release)
"Riken Genesis Co., Ltd...Amoy Diagnostics Co., Ltd...Precision Medicine Asia Co., Ltd...announced that in April 2022, AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was filed in Japan as a companion diagnostic for Retevmo (selpercatinib)...The aim of this application is to obtain approval as a companion diagnostic for RET fusion-positive non-small cell lung cancer (“NSCLC”), for Retevmo capsules 40 mg and 80 mg (common name: selpercatinib) marketed by Eli Lilly Japan K.K."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
11ms
AmoyDx Enters into Master Collaboration Agreement with AstraZeneca for Multiple Companion Diagnostics Programs in China, EU and Japan (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...announces that it has entered into a Master Collaboration Agreement (Agreement) with AstraZeneca...The master collaboration agreement enables the Parties to collaborate in the development and commercialization of AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines globally....The first projects to be initiated under the Agreement include the co-development of a CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the EU and Japan, and a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza® (olaparib) monotherapy."
Licensing / partnership
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Lynparza (olaparib)
12ms
AmoyDx signs strategic cooperation agreement with HUTCHMED in China (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...and HUTCHMED (China) Limited...announced the signing of a strategic cooperation agreement in the companion diagnostic field. The agreement will enable the two sides to jointly promote the development of molecular diagnostics in Osimertinib/Savolitinib Combo treatment for NSCLC in the Chinese market."
Licensing / partnership
1year
China's NMPA granted approval to AmoyDx® PD-L1 Expression Detection Kit (IHC) (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...announced that China’s National Medical Products Administration (NMPA) recently granted Approval to AmoyDx® PD-L1 Expression Detection Kit (IHC) for guiding the first-line treatment of Pembrolizumab in non-small cell lung cancer patients."
Non-US regulatory
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AmoyDx® PD-L1 Expression Detection Kit
1year
Notice concerning application for partial revision of manufacturing and marketing approval of companion diagnostic reagent for the AmoyDx® Pan Lung Cancer PCR Panel (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today announced that an application for partial revision of manufacturing and marketing approval for AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was submitted in February 2022...The aim of the Application for Partial Change is to obtain approval as a companion diagnostic for ROS1 fusion genes, for the anti-tumor agent/tyrosine kinase inhibitor Rozlytrek® capsules 100 mg and 200 mg (common name: Entrectinib), marketed by Chugai Pharmaceutical Co., Ltd."
Non-US regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
1year
AmoyDx collaborates with Pierre Fabre to develop companion diagnostics for China market (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...and the French pharmaceutical group Pierre Fabre announced that the companies have entered into a collaboration to develop Companion Diagnostic (CDx) kits in China, supporting encorafenib and binimetinib marketing authorization applications...AmoyDx will provide Pierre Fabre with kits to detect BRAF mutation in tumor samples. These Companion Diagnostics (CDx) candidate kits are currently being validated in two clinical studies in China, to demonstrate they are correctly selecting the right patients for optimized use of treatment with encorafenib +/- binimetinib."
Licensing / partnership
1year
AmoyDx announces its PLC panel adopted as companion diagnostic for brigatinib in Japan (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...today announced that the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') has been adopted by Takeda Pharmaceutical Company Limited in Japan as one of the companion diagnostics for Brigatinib, its tyrosine kinase inhibitor for identifying ALK+ patients with non-small cell lung cancer (NSCLC)."
Clinical
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AmoyDx® Pan Lung Cancer PCR Panel
1year
AmoyDx and PREMIA announce the commercial launch of the AmoyDx® Pan Lung Cancer PCR Panel in Japan (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd and PREMIA Holdings (HK) Limited...announced the commercial launch of the AmoyDx® Pan Lung Cancer PCR Panel (the 'PLC Panel') in Japan as a reimbursed companion diagnostic for multiple anti-cancer agents. AmoyDx is the inventor and manufacturer and PREMIA the developer of the PLC Panel in Japan."
Launch Japan
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
Amoy Diagnostics and Janssen China sign MoU on strategic collaboration (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd....recently signed a Memorandum of Understanding (MoU) on strategic collaboration with The Janssen Pharmaceutical Companies of Johnson & Johnson...AmoyDx will further empower patients to use management of the whole course of disease and, while improving the accessibility of concomitant diagnosis and accelerating patient reimbursement, it will further optimize the diagnosis of Janssen’s key target therapeutic areas including lung cancer and urothelial cancer."
Licensing / partnership
over1year
AmoyDx collaborates with Amgen to develop companion diagnostics for Japan market (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...and Amgen Inc...announced today that the companies have entered into a strategic collaboration to develop a Companion Diagnostic (CDx) kit in Japan, supporting sotorasib, a novel small molecule that specifically and irreversibly inhibits KRAS G12C in patients with Non-Small Cell Lung Cancer...Under the terms of the collaboration, AmoyDx will develop its CDx kit: AmoyDx® Pan Lung Cancer PCR Panel (AmoyDx® PLC Panel)...for a further extended use as a follow-on CDx for sotorasib."
Licensing / partnership
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AmoyDx® Pan Lung Cancer PCR Panel
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Lumakras (sotorasib)
over1year
AmoyDx Pan Lung Cancer PCR Panel Receives MHLW Approval as Companion Diagnostic for TEPMETKO (tepotinib) (GlobeNewswire)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd.,...and Precision Medicine Asia Co., Ltd...announced that the Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for TEPMETKO® (tepotinib) a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
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Tepmetko (tepotinib)
over1year
AmoyDx Pan Lung Cancer PCR Panel receives MHLW approval as companion diagnostic for 9 targeted therapies for use in patients with advanced non-small cell lung cancer (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics…and Precision Medicine Asia….announced that the AmoyDx® Pan Lung Cancer PCR Panel (the ‘AmoyDx PLC Panel’), an in vitro diagnostic reagent developed as a companion diagnostic for multiple anti-cancer agents, was approved by Ministry of Health, Labour and Welfare (MHLW) for production and marketing in Japan on June 25, 2021. The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology, and can simultaneously evaluate the presence of 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
2years
AmoyDx signs agreement with Haihe Biopharma to co-develop companion diagnostics for the United States market (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...and Haihe Biopharma announced that they signed an agreement to use the MET mutation detection kit of AmoyDx as Companion Diagnostic (CDx) assay supporting the registration of Haihe's MET kinase inhibitor Glumetinib (SCC244) in the United States of America...Under the terms of the agreement, AmoyDx will develop and register the AmoyDx® MET Mutation Detection Kit in the United States, to get the Premarket Approval (PMA) for an intended use as a c-MET exon14 skipping CDx for Haihe's Glumetinib (SCC244), a novel MET kinase inhibitor targeting c-MET exon14 skipping alterations, in subjects with Non-Small Cell Lung Cancer."
Licensing / partnership
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AmoyDx MET Mutation Detection Kit
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gumarontinib (SCC244)
2years
AmoyDx collaborates with AstraZeneca to co-develop HRD companion diagnostics for ovarian cancer (AmoyDx Press Release)
"Recently Amoy Diagnostics Co., Ltd...announced that it signed an agreement with AstraZeneca to develop a Homologous Recombination Deficiency (HRD) Companion Diagnostic (CDx) in ovarian cancer. The agreement was signed during the China HRD Testing Alliance Founding Conference with the aim to join efforts of HRD CDx kit development and its post-launch marketing in ovarian cancer."
Licensing / partnership
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AmoyDx® HRD Focus Panel
over2years
AmoyDx signs memorandum with AstraZeneca to cooperate in molecular diagnostics in gynecological oncology worldwide (AmoyDx Press Release)
"Recently Amoy Diagnostics Co., Ltd…signed a collaborative memorandum with AstraZeneca in the third China International Import Expo…Nowadays, AmoyDx and AstraZeneca would work together in the field of gynecological oncology and expand the cooperation beyond China to many countries in the world. This strategic collaboration will benefit gynecological cancer patients that often have homologous recombination repair (HRR)/homologous recombination defects (HRD) that play an important role in the development of cancer and where drugs such as PARP inhibitors may help."
Licensing / partnership
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AmoyDx® HRD Focus Panel
over2years
AmoyDx collaborates with Haihe Pharmaceutical to co-develop companion diagnostics for Japan market (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd…announced that it signed an agreement with Haihe Pharmaceutical to develop a Companion Diagnostic (CDx) test supporting the novel MET inhibitor Glumetinib (SCC244)….Under the terms of the agreement, AmoyDx will develop and register the AmoyDx® Pan Lung Cancer PCR Panel (9-in-1 Plus) in Japan, to get the PMDA approval for an intended use as a c-MET exon14 skipping companion diagnostic for Haihe's Glumetinib (SCC244), a novel MET kinase inhibitor targeting c-MET exon14 skipping, in subjects with Non-Small Cell Lung Cancer."
Licensing / partnership
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AmoyDx® Pan Lung Cancer PCR Panel
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gumarontinib (SCC244)