AmoyDx^® HANDLE Breast Cancer Liquid NGS Panel Performance Evaluation

The AmoyDx^® HANDLE Breast Cancer Liquid NGS Panel demonstrates high sensitivity and specificity in detecting variants within the SeraSeq ESR1 and PI3KCA reference materials. Leveraging ultrasensitive HANDLE Liquid technology, the assay delivers superior detection performance while offering a streamlined NGS workflow as easy as PCR.

AmoyDx^® Super-ARMS ESR1 Performance Evaluation

The AmoyDx^® Super-ARMS ESR1 PCR Kit exhibits high sensitivity and specificity in detecting 11 clinically prevalent ESR1 mutations within the Seraseq ESR1 reference panel. Utilizing ultrasensitive Super-ARMS technology, this assay achieves a limit of detection (LOD) of 0.2% with a 30ng DNA input, offering superior detection sensitivity compared to conventional qPCR methods. It provides laboratories with a user-friendly solution compatible with standard molecular equipment. The platform surpasses next-generation sequencing (NGS) in operational simplicity, cost-effectiveness, and rapid turnaround time (TAT), making it an efficient and reliable choice for ESR1 mutation detection.

AmoyDx^® Essential NGS Panel Approved as Dual Specimen Companion Diagnostic for RYBREVANT^® in China

The plasma-based version of AmoyDx^® Essential NGS Panel (Reversible Terminator Sequencing Method) was approved by the National Medical Products Administration (NMPA) as the primary companion diagnostic (CDx) for RYBREVANT^® (amivantamab-injection), developed by Johnson & Johnson, for the detection of EGFR exon 20 insertion mutations (EGFR exon20ins) in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

AmoyDx^® Essential NGS Panel Approved as Companion Diagnostic for RYBREVANT^® (Amivantamab Injection) in China for EGFR Exon 20 Insertion Mutations in NSCLC

the AmoyDx^® Essential NGS Panel was approved as the companion diagnostic for RYBREVANT^®, supporting clinical treatment decisions through reliable detection of EGFR exon 20 insertion mutations.

AmoyDx^® Pan Lung Cancer PCR Panel submission for regulatory approval in Japan for the additional indication of Amivantamab plus Lazertinib combination therapy

Riken Genesis and AmoyDx today announced that they have submitted a partial change application to the MHLW for the AmoyDx^® Pan Lung Cancer PCR Panel for the additional indication of Amivantamab plus Lazertinib combination therapy in Japan.

AmoyDx^® Pan Lung Cancer PCR Panel Application for Approval in Japan as a Primary Companion Diagnostic for Taletrectinib

Riken, AmoyDx and PREMIA today announced that they have submitted a partial change application to the MHLW (Ministry of Health, Labour and Welfare) for the AmoyDx^® Pan Lung Cancer PCR Panel as a companion diagnostic (CDx) for Taletrectinib in Japan.

AmoyDx^® PD-L1 (E1L3N) Assay Expands Companion Diagnostic Indication to Gastroesophageal Adenocarcinoma in China

The AmoyDx^® PD-L1 (E1L3N) assay has obtained approval from China’s National Medical Products Administration (NMPA) as a companion diagnostic (CDx) for detecting PD-L1 expression in FFPE tissue sections of gastric adenocarcinoma / gastroesophageal adenocarcinoma (GA/GEA), aiding in the identification of patients eligible for treatment with sugemalimab in combination with chemotherapy.

AmoyDx^® Pan Lung Cancer PCR Panel application for approval in Japan as a Companion Diagnostic for LORBRENA^® (Lorlatinib)

Riken Genesis, AmoyDx, and PREMIA today announced that they have submitted a partial change application to the MHLW (Ministry of Health, Labour and Welfare) for the AmoyDx^® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) as a companion diagnostic (CDx) for LORBRENA^® (Lorlatinib tablets) in Japan. 

AmoyDx Holds Successful 2024 Distributors Annual Meeting in Düsseldorf, Germany

Amoy Diagnostics (“AmoyDx”) successfully hosted its 2024 Distributors Annual Meeting in the dynamic city of Düsseldorf, Germany, bringing together distribution partners from across the globe for a day of insightful discussions and collaborative knowledge sharing focused on advancing oncology diagnostics.

AmoyDx^® HRD Complete Panel Enters China NMPA’s Special Review Procedures for Innovative Medical Devices

AmoyDx^® HRD Complete Panel has been accepted into the Special Review Procedure for Innovative Medical Devices by the China National Medical Products Administration (NMPA).

AmoyDx^® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for AUGTYRO^® (repotrectinib)

The AmoyDx^® Pan Lung Cancer PCR Panel has received approval in Japan as a companion diagnostic (CDx) for AUGTYRO^® (repotrectinib) for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with ROS1 fusion gene.

AmoyDx^® Pan Lung Cancer PCR Panel Receives China NMPA Approval

China NMPA approved AmoyDx^® Pan Lung Cancer PCR Panel for use in identifying EGFR, ALK, ROS1, and METex14 skipping mutations in non-small cell lung cancer (NSCLC) patients.

AmoyDx^® FGFR2 Break-apart FISH Probe Kit Approved as Companion Diagnostic for Eisai’s Tasurgratinib in Japan

AmoyDx^® FGFR2 Break-apart FISH Probe Kit has received approval in Japan as a companion diagnostic (CDx) for Eisai’s groundbreaking targeted therapy, Tasurgratinib.

AmoyDx^® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for Haiyitan^® tablets (gumarontinib)

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 Haiyitan^® (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan^® in 50 mg tablet form, was approved by MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations.

AmoyDx and Servier Enter into a Collaboration to Develop an IDH1/2 Companion Diagnostic Test for Diffuse Glioma in China

AmoyDx and Servier entered into a strategic partnership to develop a companion diagnostic test (CDx) in China that detects Isocitrate Dehydrogenase (IDH) 1&2 gene mutations.

AmoyDx Wins National Manufacturing Single Champion Enterprise Title!

AmoyDx has proudly made the list of manufacturing champions by the Ministry of Industry and Information Technology.

AmoyDx Collaborates with Boehringer Ingelheim to Develop Companion Diagnostics for Lung Cancer Patients in China

AmoyDx announced a collaboration with Boehringer Ingelheim to develop a Companion Diagnostic (CDx) kit for non-small cell lung cancer (NSCLC) patients in China.

AmoyDx^® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for TABRECTA (Capmatinib)

AmoyDx^® Pan Lung Cancer PCR Panel has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic for TABRECTA™ (capmatinib)