PCRM president Neal Barnard, M.D., announced today that PCRM has developed the world's first cruelty-free insulin assay, a test used to measure insulin levels in individuals with diabetes. The assay, which uses no animals, was developed as part of PCRM's ongoing clinical trials to test the effects of a low-fat, vegan diet on patients with type 2 diabetes.
"We only had two options available to us when we began our diabetes trials," said Dr. Barnard. "One, we could use test kits with insulin antibodies grown in vivo--literally from cells injected into the abdomens of live mice--or we could use kits containing antibodies produced from cells cultured with fetal calf serum. Neither was acceptable to us."
The answer? Develop an in-vitro, or test-tube, procedure using a synthetic replacement for the fetal calf serum used as a culturing medium in millions of medical tests every year.
After months of painstaking detective work, PCRM research analyst Megha Even, M.S., working with BiosPacific, an Emoryville, California, lab, succeeded in culturing cells using an animal component-free, peptide- and protein-free, media supplement as a replacement for calf serum--basically a synthetic formula with cofactors and trace elements that promote cell growth. Then, in collaboration with Linco Research of St. Charles, Missouri, Even successfully incorporated antibodies grown in the medium into a test kit for human insulin.
A report on the new methodology will be published soon in a peer-reviewed journal in conjunction with Linco. Even will present her findings at the "Experimental Biology 2005" scientific conference in San Diego, April 2-6. The new assay ki ts are available commercially from Linco.
"We hope that by making the test readily available and competitively priced, researchers and medical labs will use it," said Barnard. "We have proven that if researchers are willing to make the effort, there are effective, humane alternatives to animal-based assays and other testing procedures--alternatives that could help save the lives of millions of people and animals."
There are an estimated 194 million people worldwide with diabetes. More than 15 million Americans suffer from the disease and resulting complications.