TEST:

AmoyDx® Pan Lung Cancer PCR Panel

A bronchoscopy with transbronchial lung biopsy of the right S5 nodule confirmed the diagnosis of adenocarcinoma. The biopsy specimen was analyzed using the AmoyDx® Pan Lung Cancer PCR Panel, which detected ROS1 fusions.

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel...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."

"Amoy Diagnostics Co., Ltd...recently announced that the China National Medical Products Administration (NMPA) has approved its AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') for use in identifying EGFR, ALK, ROS1, and METex14 skipping mutations in non-small cell lung cancer (NSCLC) patients."

Conclusions The frequency of AGAs in early-stage NSCLC was similar to that previously being reported for advanced NSCLC. Genomic screening for early-stage NSCLC could help to detect AGAs particularly in non-Sq NSCLC.

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...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 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."

FCPs can be successfully used in the AmoyDx PLC panel, with higher success rate compared with the NGS assay. The AmoyDx PLC panel may be an option in cases when insufficient tissue sample is available for the NGS assay.

The ODxTT missed two uncovered EGFR rare variants, which was visually confirmed in the raw sequencing data. Our study provides insights into real-world performance of CDx tests for lung cancer and ensures reliability to advance precision medicine.

"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 TABRECTATM (capmatinib), a product of Novartis AG, Basel, Switzerland which was approved by the Japanese MHLW in June 2020."

"The detection rate of driver oncogene alterations for all histologies was 52.4% (111/212), and that for adenocarcinoma was 69.7% (106/152). A favorable submission rate and success rate of multi-gene panel tests were shown, along with a favorable detection rate in recent clinical settings."

CS exhibit an extremely high success rate for multi-gene analysis, with nucleic acid yield comparable to TS. Moreover, the concordance rate of gene alteration between CS and TS is also remarkably high. CS emerge as a viable alternative to TS for analyzing driver gene alteration in multi-gene PCR analysis.

Additionally, three of the patients, who had measurable tumors, showed partial responses to afatinib and osimertinib. The L858R mutation associated with L858R-K860I and L858R-L861F doublet mutations could be detected using Idylla but not cobas EGFR tests. Using next-generation sequencing analysis should be considered after initial negative reports from the cobas test, because patients with L858R doublet mutations may benefit from EGFR-TKIs.

The AmoyDx PLC panel, a PCR-based multiplex diagnostic test, exhibits a high success rate. The frequency of the nine genes targeted for treatment detected by the AmoyDx PLC panel was comparable to the frequency of mutations detected by ODxTT-M. Clinicians should understand and use the AmoyDx PLC panel and ODxTT-M with respect to their respective performances and limitations.

The overall concordance rate was 93.3%, with concordance rates for each group are 97.7% (2-3 years), 100% (4 years), and 80.0% (≥ 5 years), respectively. Conclusions PCR effectively detects mRNA in long-term preserved FFPE samples, providing valuable variant information for treatment guidance in NSCLC patients, even after extended storage periods.

These findings suggest that while both CDx tests are effective in detecting almost all actionable EGFR mutations, ODxTT provides slightly broader coverage. These results emphasize the importance of selecting appropriate CDx tests to inform treatment decisions for EGFR-positive NSCLC patients.

In the retrospective analysis, mPCR identified EGFR ex20ins in an estimated 79.0% (502/636) of pts. Conclusions The AmoyDx mPCR assay performed better than traditional PCR and effectively identified pts with EGFR ex20ins+ NSCLC who may benefit from mobocertinib therapy, providing a fast and effective diagnostic option to guide treatment.

Conclusions Multi-PCR panel showed a high success rate and a short TAT in genomic screening by preoperative biopsy tumor samples. Multi-PCR panel would help to better detect actionable oncogenic drivers in patients with early-stage NSCLC.

Most of interestingly, for EGFR exon 20 insertion (EGFR ex20ins), a good concordance rate of 99.6% (PPA: 100.0% and NPA: 99.6%) was achieved. Table: 1238P Comparison of AmoyDx 11-gene PCR and NGS for detecting known driver genes in NSCLC patients Conclusions AmoyDx 11-gene PCR displayed high concordance to NGS in detecting driver mutations of NSCLC, especially rare drivers (EGFR ex20ins), suggesting it is an excellent choice in clinical practice.

AMOY had a higher success rate, shorter turnaround time, and higher detection rate than NGS panels. Only a limited number of mutant variants were included; thus be careful not to miss promising targetable driver mutations.

No abstracts available

"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today 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 RET fusion-positive non-small cell lung cancer ('NSCLC'), for selpercatinib capsules 40 mg and 80 mg. The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 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."

"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."

In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201)... Detection of rare mutations require sensitive and specific diagnostic assays. AmoyDx HER2 Mutation Detection Kit demonstrated robust performance in detecting representa-tive HER2 indel and single nucleotide variant mutations at low frequencies. The AmoyDx Pan Lung Cancer PCR assay showed similarly robust and sensitive detection of the common HER2 A775_G776insYVMA indel in addition to detecting clinically relevant EGFR mutations.

"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."

"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."

"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."

"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."

"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)."

"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."

Both the 9-in-1 test and Genexus/OPA had short TATs (3−4 days), high success rates (96−98%) and good concordance (95−98%) compared with another NGS assay (OCA) . These rapid multi-gene assays highly contributed to enabling precision medicine and the development of targeted therapies for advanced NSCLC.

There was high concordance rate of the results between the assays. RNA quality in FFPE may show some limitations and performed better on the PCR panel. Both assays have their own advantages.