IUO definition

IUO means an Assay that is labeled for “investigational use only”.

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IUO means Products labeled “investigational use only.”

IUO or “Investigational Use Only” means an IVD for investigational use only that meets certain clinical and manufacturing standards and that is used in clinical studies (that are exempt from FDA’s Investigational Device Exemption or IDE regulations, 21 C.F.R. 812) to gather data for submission as required by the FDA or another Regulatory Authority to obtain Regulatory Approval of such IVD as an Approved IVD.

Examples of IUO in a sentence

• Title: Interim Director Title: VP, IP and Legal Affairs Date: February 22, 2007 Date: 2/28/2007 Fields of Use: Human clinical diagnostics field, including Research Use Only (RUO), Investigational Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (IVD) fields of use for anticoagulant dosing.

• The license granted under this Agreement for each Future Licensed Product for investigational use only ("IUO") shall terminate unless CDS begins active development of such Future Licensed Product within six (6) months of the date of the written notice by CDS to GEN-PROBE under Section 3.1 above and CDS accomplishes the first commercial sale of the IUO Future Licensed Product within eighteen (18) months of the date of the written notice by CDS to GEN-PROBE.

• The Ventana IUO will first be developed and optimized on the Benchmark ULTRA automated system.

• At the initiation of Stage 1, Blueprint and Ventana will agree to develop an IUO for BLU-554 in HCC.

• If the Ventana IUO is not ready to be transferred to commercial laboratories for the start of an BLU-554 pivotal study, Blueprint and Ventana will negotiate in good faith the terms of separate Project Schedules (i) for patient screening using the prototype Ventana Assay at Ventana’s CAP/CLIA laboratory and (ii) any resulting bridging studies that are required for the Ventana Assay to gain Regulatory Approval.

• The Ventana IUO will be developed under full design control as per Ventana’s Product Development Process (“PDP”), and will be developed through stage gates known as Early Concept (“EC”), Design Goals (“DG”), Design Input (“DI”), and Design Output (“DO”).

• A diagnostic clinical trial protocol will be written and a clinical site initiation visit (“SIV”) will be completed at the start of each Clinical Trial, to ensure proper data capture and operations to support the clinical development of the IUO.

• Ventana will use commercially reasonable efforts to have Ventana IUO ready for BLU-554 pivotal Clinical Trials.

• For clarity, while the Ventana CAP/CLIA laboratory is qualified to be a testing lab for pivotal studies, it is Ventana’s recommendation that the Ventana IUO be transferred to a commercial laboratory(ies) other than Ventana’s CAP/CLIA certified laboratory for use in registrational Clinical Trials.

• In the event the Ventana IUO will not be ready, a Joint Project Team will identify contingencies to select patients for such trials such as incorporating the Ventana CAP CLIA Lab.

More Definitions of IUO

IUO means an assay for investigational use only that meets certain clinical and manufacturing standards and which is used in clinical studies to gather data for submission to a Regulatory Agency in support of an Approved Assay.