AIBioTech announces implementation of L-asparaginase activity assay for pediatric ALL

AIBioTech™ is pleased to announce implementation of a new laboratory derived test to measure L-asparaginase levels in patients being treated with any of the current asparaginase drugs including: Oncaspar®, Kidrolase®, Erwinaze™, and Elspar®.

About 5,500 new cases of pediatric acute lymphoblastic leukemia (ALL) are diagnosed in the United States each year. Unlike healthy cells, leukemia cells cannot make their own supply of asparagine, an essential amino acid nutrient, and are dependent on obtaining asparagine from a leukemia patient's blood serum.

In administering the L-asparaginase enzyme to patients, serum levels of asparagine are depleted, leaving the leukemia cells without asparagine, which results in leukemic cell death. Unfortunately, many patients treated with L-asparaginase form antibodies to the enzyme, and do not experience any clinical signs of hypersensitivity. Yet these antibodies can either inactivate the enzyme or enhance the metabolism of asparaginase such that the patient may not have adequate serum or plasma activity levels to achieve an anti-leukemic effect. This is often referred to as "silent inactivation" or "silent hypersensitivity."

The L-asparaginase activity assay developed at AIBioTech™ is intended to help physicians identify patients experiencing "silent inactivation" of asparaginase as well as to ensure that adequate asparaginase activity is present during treatment. The assay will measure asparaginase activity levels in the dosed patient, regardless of the form of the drug which is administered.

"Kudos goes to our biological chemistries group headed by Dr. Russ Wolz. They recognized this important clinical problem and rapidly instituted this innovative solution," said Dr. Robert B. Harris, AIBioTech™ President and Chief Scientific Officer.

"Our intended customers are pediatric and adult cancer centers which routinely administer L-asparaginase as a therapeutic drug. We have already seen considerable interest from attending physicians, governing groups, and the drug manufacturers themselves. We hope that this new assay will gain widespread acceptance and prove another useful tool for patient care," said Harris.

This L-asparaginase activity assay has been fully validated in the AIBioTech™ laboratories in accordance with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements and as defined in the U.S. Food and Drug Administration (FDA) Guidance for Industry on Bioanalytical Method Validation and according to the International Conference on Harmonization Guidelines on Validation of Analytical Procedures.

Source: AIBioTech