Abbott Molecular expects to launch six FISH tests in Europe in coming months for use by diagnostic laboratories in identifying chromosomal abnormalities associated with certain forms of leukemia, the company announced this week.
The following six probes, which are already available in the US, have received CE mark certification, allowing them to be commercially marketed in the European Union. They include the Vysis LSI p53/LSI ATM and LSI D13S319/LSI 13q34/CEP 12 Multi-Color Probe Sets; Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set (20 assays and 50 assays); Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set; Vysis LSI BCR/ABL Dual Color, Single Fusion Translocation Probe Set; Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe; and Vysis LSI 21 SpectrumOrange Probe.
The FISH tests employ DNA probes used to detect genetic abnormalities common in patients with acute lymphocytic leukemia, chronic myeloid leukemia, and chronic lymphocytic leukemia. These “are intended to supplement conventional cytogenetics and provide additional information not detected by other test methods,” Abbott said in a statement.
According to the company, combining conventional cytogenetics – which may reveal changes in large chromosomes – with the specifically targeted FISH method may help physicians make more accurate treatment decisions. "Certain genetic aberrations can be important indicators of whether a patient has a particularly aggressive form of leukemia or whether they will respond to certain therapies," Abbott Molecular Medical Director Timothy Stenzel said in a statement.
These products represent the first in a series of CE-marked DNA probes that Abbott Molecular expects to launch in Europe in the coming months. Future probes will be for variety of applications in cancer and genetic testing.
Genzyme launched a new laboratory test to identify non-small cell lung cancer patients who are non-responsive to targeted therapies. Genzyme's KRAS Mutation Analysis will help identify NSCLC patients who test positive for specific KRAS mutations, which have been associated with resistance to OSI’s Tarceva and AstraZeneca’s Iressa tyrosine kinase inhibitors.
The company claims it is the only US national commercial laboratory to offer this new test.
"Between 15 and 30 percent of tumors from NSCLC patients have mutations in the KRAS gene and clinical studies show that this information plays an important role in making treatment decisions," said Genzyme Genetics President Mara Aspinall.
Genzyme Genetics is the diagnostics testing unit of Genzyme Corporation. Aspinall identified the convergence of Genzyme’s diagnostics and therapeutics components as a “priority for the company.”
In addition to the new KRAS Mutation Analysis, Genzyme Genetics offers two other tests in its portfolio that help identify NSCLC patients likely to respond to TKI therapies. The company launched an EGFR FISH test earlier this year to detect amplification of the EGFR gene and has an EGFR Mutation Analysis Assay, which detects the presence of EGFR mutations in NSCLC patients.