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FDA Okays First Genetic Test for Chronic Lymphocytic Leukemia Prognosis

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Originally published August 22.

The US Food and Drug Administration this week granted 510(k) clearance to Abbott's Vysis CLL FISH Probe Kit to gauge the progression of chronic lymphocytic leukemia.

CLL is a cancer that impairs patients' lymphocytes, a kind of white blood cells that are critical for the body's immune system. The Vysis CLL test gauges gene abnormalities in lymphocytes that are associated with the progression of CLL.

The Vysis CLL Kit gauges "a panel of five individual FISH probes intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell CLL," the company said in a statement. "The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology, and other clinical information."

More than 15,000 patients are diagnosed with CLL each year, making it the most common form of leukemia in the US. Around half of CLL patients are at risk for accelerated progression of the disease, while other patients experience slower disease progression, and some may not even require treatment. Abbott's new kit aims to help doctors gauge which early-stage patients may experience rapid disease progression and as such will require treatment.

According to Abbott, its kit is the first FDA-cleared test to aid in prognosis of CLL. The test, however, is not cleared by the FDA for use in therapy selection or for monitoring residual disease, the company noted.

Abbott estimates that genetic aberrations play a role in 80 percent of CLL cases. Guidelines from the National Comprehensive Cancer Network suggest that tools that gauge chromosomal anomalies may be valuable in CLL prognosis.

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