On January 23, 2023 ALERCELL, INC. reported that it has introduced a new Research Use Only (RUO) LENA Q51 Leukemia diagnostic test for commercial sale. LENA Q51 was developed to detect up to 51 genes mutations associated with Leukemia (Press release, Alercell, JAN 23, 2023, View Source [SID1234626468]).
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LENA Q51 is available for early detection of any type of Leukemia and is a gigantic leap forward in Leukemia detection. The RUO LENA Q51 will be available while the company completes clinical trials and regulatory submissions to support U.S. Food and Drug Administration (FDA) approval for broader clinical use.
The innovative approach of LENA Q51 Leukemia Fusion Gene Kit is to target the gene mutations, the clonogenic gene rearrangements and abnormal gene expression. Fusion genes are one of the most common biomarkers in Leukemia and are caused by chromosome breakage and recombination. Test results are available in under three hours using a standard qPCR machine compared with traditional microbiology methods, which can take two to three days and longer to provide results.
The test has an easy-to-use protocol and can be run on standard qPCR equipment and is designed to handle the workflow in a clinical microbiology lab environment. The RUO LENA Q51employs industry standard PCR and DNA purification technology.
Frederic Scheer, chairman & CEO of Alercell, stated, "The new RUO LENA Q51 was designed to improve patient outcomes and help in selecting the appropriate therapeutics for Leukemia patients. Early detection enhances drastically the survival rates of patients and Alercell is focusing on making sure that we give every patient the best chances of survival".
Initial clinical verifications will start soon, we are pleased to introduce the test for commercial sale for Research Use Only to hospitals and various cancer centers for control purposes and for pharmaceutical surveillance studies."