Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy

GenWorks Health launches IVD tests for dengue and malaria

Rapid card test kits for iScreen malaria card antigen (Pf/Pv) & iScreen dengue NS1

Takara Bio partners with BioeXsen for the distribution of CE-IVD solutions

The reliability of their products, evidenced by their inclusion in the WHO emergency use list, has further improved with the addition of Takara Bio's enzymes.

Indica Labs achieves CE-IVD certification for AI-based prostate cancer detection and Gleason grading tool

The HALO Prostate AI algorithm deployed in HALO AP from Indica Labs

Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer

Globally, cervical cancer is the fourth most common cancer among women, with approximately 30,447 new cases diagnosed in Europe in 2020

IVD system to assist assay developers and clinical labs for molecular diagnostics

Thermo Fisher Scientific expands diagnostics portfolio to support full qPCR assay development and testing workflow

DiaCarta receives CE/IVD for its Covid-19 screening test

This test can be run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-Generation Sequencing