Unicancer will provide patients with centralized laboratory testing performed by Agendia, and also adopt the company's NGS kits for decentralized testing.
The change will be felt most immediately in Europe, where the Dutch molecular diagnostics company recently secured a CE-IVD mark for its MammaPrint BluePrint kit.
The company hopes that meeting the needs of a more decentralized testing model will increase access to its products for European women with breast cancer.
Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other adjustments.
The institute will run the company's new NGS test kit in its lab, comparing results with Agendia's existing centralized microarray version of the two assays.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
