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FDA Clears Abbott Test for CLL Prognosis

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Abbott's Vysis CLL FISH Probe Kit for determining the prognosis of patients with chronic lymphocytic leukemia.

The test detects genetic abnormalities in lymphocytes, and according to Abbott is the first FDA-cleared CLL test to aid in prognosis. It includes five 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 chronic lymphocytic leukemia.

Abbott noted that the test is not intended for use in selecting therapy or monitoring of residual disease.

More than 15,000 patients are diagnosed with CLL in the US each year.

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.