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Abbott RealTime IDH1 - P170041

Packaging for Abbot RealTime IDH1

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 IDH1
PMA Applicant: Abbott Molecular Inc.
Address: 1300 E. Touhy Avenue, Des Plaines, IL 60018
Approval Date: July 20, 2018
Approval Letter: Approval Order

What is it? The Abbott RealTime IDH1 is a laboratory test intended to detect the presence of five (5) specific mutations in the isocitrate dehydrogenase-1 (IDH1) gene in blood or bone marrow from patients with acute myeloid leukemiadisclaimer icon (AML). If the test result is positive for an IDH1 mutation, the patient may be able to achieve remission and require fewer blood transfusions when treated with Tibsovo (ivosidenib), a drug that targets the mutant IDH1 protein.

How does it work? Patients with 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 five mutations that result in changes to the R132 codon (a sequence of 3 nucleotides that code for specific amino acids) of the IDH1 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 Tibsovo treatment.

When is it used? A physician may use the Abbott RealTime IDH1 test to help identify AML patients who have IDH1 mutations present in leukemia cells, which can help determine if those patients should be treated with Tibsovo.

What will it accomplish? The Abbott RealTime IDH1 test can help determine if a patient should be treated with Tibsovo.

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

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