amoy diagnostics announced at noon that the company's independently developed human homologous recombinant repair defect detection kit has recently entered the special review procedure for innovative medical instruments at the Medical Device Technology Evaluation Center of the National Medical Products Administration. The HRD test kit is a companion diagnostic product for PARPi new drug treatment, covering multiple cancers such as ovarian cancer, prostate cancer, breast cancer, and pancreatic cancer. The company is the first HRD test kit to enter the "innovative medical instruments" program in China, using its patented ADx-GSS smart algorithm to improve accuracy, meet clinical needs at home and abroad. Products entering the special review procedure for innovative medical instruments can enjoy priority processing, effectively shorten the product registration period, accelerate the listing speed, and have a positive impact on the company's future development.
艾德生物:HRD试剂盒进入创新医疗器械特别审查程序
amoy diagnostics: HRD test kit enters the special review procedure for innovative medical instruments
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