TEST:

AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit

There was an interaction between HPV type and NHIR on CIN3+. HPV integration can further assess a patient's risk based on HPV genotyping detection, which is conducive to reducing missed diagnoses. The NHIR might be a potential biomarker for early warning and precise identification of high-risk CIN lesions.

It also provides a scientific basis for stratifying the individual risk of developing CIN2 or higher lesions to guide subsequent management. Therefore, the HR-HPV genotyping testing can be considered as an effective method for cervical cancer screening.

In the age group >50 years, the HPV multiple-type infection rate detected via MPCE assay was significantly higher than that detected by the PCR-RDB assay, with a statistically significant difference (p = 0.002). To reduce the false-negative rate and improve screening efficiency, the MPCE assay, which targets the oncogenic gene E6/E7 segments, can be extended to the general female population for the early detection, diagnosis, and treatment of cervical cancer.

HPV genotyping results of the MPLC system and the MP96 system showed a high degree of concordance. Combined with the advantages of high-throughput and anti-contamination of MP96, the MP96 extraction system could more suitable for testing of samples in future studies.

"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."