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  1. Device Approvals, Denials and Clearances

Abbott RealTime IDH2 - P170005

Abbott RealTime IDH2 - P170005

Picture of the device packaging.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Abbott RealTime IDH2
PMA Applicant: Abbott Molecular Inc.
Address: 1300 E. Touhy Avenue, Des Plaines, IL 60018
Approval Date: August 1, 2017
Approval Letter: Approval letter

What is it? The Abbott RealTime IDH2 is a laboratory test intended to detect the presence of nine (9) specific mutations in the isocitrate dehydrogenase-2 (IDH2) gene in blood or bone marrow from patients with relapsed or refractory (residual leukemic cells in the marrow even after intensive treatment) acute myeloid leukemia (AML). If the test result is positive for IDH2 mutation, the patient may be able to achieve remission and require fewer blood transfusions when treated with IDHIFA (enasidenib), a drug that targets the mutant IDH2 protein. 

How does it work?

Patients with relapsed or refractory AML have cancer cells within their blood and bone marrow. A doctor collects either a blood or bone marrow sample from the patient, and sends the sample to a lab, where DNA is purified from the collected specimen. The DNA is then mixed with reagents that specifically detect the nine mutations that result in changes to the R140 and R172 codons (sequence of 3 nucleotides that code for specific amino acids) of the IDH2 gene.

If a mutation is detected, the test results, which indicate which specific mutation is present, are sent to the doctor who then makes the decision of whether to use IDHIFA treatment.

When is it used? A physician may use the Abbott RealTime IDH2 test to help identify AML patients who have IDH2 mutations present in leukemia cells, which can help determine if those patients should be treated with IDHIFA.

What will it accomplish? The Abbott RealTime IDH2 test can help determine if a patient should be treated with IDHIFA.

When should it not be used? There are no known contraindications.

Additional information (including warnings, precautions, and adverse events):