Genzyme introduces the first identity assay ensuring chondrocytes are implanted when using Carticel

Genzyme Corporation announced in a press release that the FDA has approved a chondrocyte identity assay for Carticel (autologous cultured chondrocytes). This is a unique and proprietary genetic assay that distinguishes chondrocyte cells, found in articular cartilage, from other cell types. The approval of this assay marks the fulfillment of the final post-approval commitment to the FDA for Carticel by Genzyme. This is the first and only assay of its kind to be developed by a commercial laboratory.

“Genzyme is committed to applying the latest scientific advancements to continuously improve our products,” stated David W. Levine, MD, MPH, vice president, clinical research, Genzyme Biosurgery, the business unit of Genzyme Corp. “Over the past decade there has been great progress in understanding the human genome and developing micro-array technology. The scientific team that supports Carticel manufacturing has applied these advances to accurately and efficiently confirm on a patient specific basis that the cells cultured for Carticel implantation are chondrocytes.”

When a biopsy is taken from a patient it is possible that other cells, such as synovial cells, are included. This novel assay will provide treating surgeons and patients additional assurance that their Carticel implant is comprised of positively identified chondrocyte cells, the only type of cell that is genetically pre-disposed to form hyaline-like cartilage which has properties similar to native articular cartilage. By the end of the year, all Carticel implants will be tested with this assay, the company claims in the release.

“Genzyme has demonstrated a continued commitment to the field of cartilage repair,” stated Tom Minas, MD, associate professor at Harvard Medical School and director of the Cartilage Repair Center at the Brigham and Women’s Hospital in Boston, Mass. “This recent development provides me with an additional layer of confidence that the cells I implant in my patients are end-differentiated cartilage cells only, allowing for the best chance of an excellent clinical outcome."