Business
CORRECTION BY SOURCE: Corporate Update on Clinical Evaluation of MedMira's Products
Correction: Extended clarification. HALIFAX, NS / ACCESSWIRE / February 1, 2024 / Today, Med...
About this update from Medmira Inc.
[{"type":"text","content":"CORRECTION BY SOURCE: Corporate Update on Clinical Evaluation of MedMira's ProductsCorrection: Extended clarification.HALIFAX, NS / ACCESSWIRE / February 1, 2024 / Today, MedMira Inc. (MedMira) (TSXV:MIR) is pleased to provide an update on the ongoing review process by Health Canada. The Company made the submission and since then has been working with the regulator on the additional clarifications and at the same time has been working towards extending its intended use highlighting the increasing need in maternity screening.MedMira is committed to provide the fastest and most accurate solution to the increasing infection rates for infectious and congenital syphilis. Whereas the infection rates over the past 10 years increased by 73% among males, the rate among females increased by 773%. As a result, congenital syphilis (syphilis transmitted during pregnancy to babies) led to a rise in severe and life-threatening illnesses with up to 40% of babies being stillborn.The Company's syphilis component showcased an overall performance of a PPA of 86.0% (95% CI 82.7-88.8%) and an NPA of 99.5% (98.8-99.8%). Notably, when the RPR titre was > 1:8 dilutions-indicative of an infectious case-the performance significantly improved to a PPA of 98.3% (95.7-99.3%) and an NPA of 99.5% (98.8-99.8%). This is particularly promising as it aligns with the marker for newly diagnosed infectious syphilis cases the study.Furthermore, in a subset analysis involving specimens from women at various pregnancy stages, the MedMira's test exhibited high quality results. Specifically, the test accurately identified all previously syphilis-infected cases, demonstrated reliability in confirming negatives, and presented potential for maternity screening. In order to demonstrate this, the Company expanded its overall data pool with additional specimens including those from various pregnancy stages among negative and positive syphilis cases. This is the final comprehensive data set to be submitted by the end of February 2024 for the additional claims approval.\"We are excited about the data achieved which underline the high quality of our products. It is my firm believe that the data will be a positive proof our capability and quality, not only for regulators but also for our future customers.\" said Hermes Chan, CEO of MedMira. \"We remain committed to advancing hea...