https://www.prnewswire.com/news-releases/roche-to-develop-companion-diagnostic-test-to-help-identify-patients-eligible-for-anti-pd-1-therapy-based-on-biomarker-expression-not-location-of-solid-tumors-300762953.html
/PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it entered into a collaboration with Merck (known as MSD outside the United States...
companion diagnostictest helprochedevelopidentify
https://www.prnewswire.com/news-releases/ventana-seeks-fda-premarket-approval-for-alk-ihc-companion-diagnostic-to-benefit-lung-cancer-patients-300022063.html
/PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced its FDA submission for premarket approval (PMA) of the...
fda premarket approvalcompanion diagnosticventanaseeksalk
https://www.tga.gov.au/resources/guidance/understanding-regulatory-requirements-vitro-diagnostic-ivd-companion-diagnostics-cdx
Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
regulatory requirementscompanion diagnosticsunderstandingvitroivd