PMA P160045S028

Device: Oncomine™ Dx Target Test
Applicant: Life Technologies Corporation
Product code: PQP
Decision date: 2021-08-25
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of single nucleotide variants in IDH1 in cholangiocarcinoma patients who may benefit from treatment with TIBSOVO (ivosidenib).

Current openFDA PMA Record#

Device: Oncomine™ Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S028
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2021-08-25
Decision code: APPR
Date received: 2021-03-02
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of single nucleotide variants in IDH1 in cholangiocarcinoma patients who may benefit from treatment with TIBSOVO (ivosidenib).