NASHVILLE, TN -- (Marketwired) -- 09/30/13 -- Insight Genetics today announced it has entered into an exclusive, worldwide licensing agreement with St. Jude Children's Research Hospital for a genetic test known as the KIR/KIR-Ligand Assay. The test helps to predict the success of bone marrow transplants by identifying the optimal bone marrow donor subtype. Use of the KIR/KIR-Ligand Assay has been shown to prevent the return of cancer in transplant recipients and reduce risk of death following bone marrow transplantation by about 60 percent. As part of the agreement, Insight Genetics will optimize the KIR/KIR-Ligand Assay for rapid, high-capacity use and make it broadly available to physicians and their patients as well as donor registries.
"When successful, bone marrow transplants can transform patients' lives," said Wing Leung, MD, PhD, Chair of St. Jude's Department of Bone Marrow Transplantation and Cellular Therapy. "This is why it's critical we do everything we can to ensure the best match between donor and recipient. The KIR/KIR-Ligand Assay has great potential in helping to identify the best transplant donors and improve outcomes for patients worldwide."
The U.S. Health Resources and Services Administration estimates that each year more than 18,000 Americans are diagnosed with life-threatening illnesses for which bone marrow transplants are the best treatment option. There are millions of individuals registered as potential bone marrow donors, but effectively matching a patient in need of a transplant with the right donors is a difficult process.
According to the World Health Organization, when donors and recipients are optimally matched, bone marrow transplants can cure more than 90 percent of patients with blood and lymph cancers. The KIR/KIR-Ligand Assay has the potential to make the screening process more efficient and effective, greatly increasing the volume and quality of the donor-patient match. In fact, it is estimated that the test could assist in improving donor matches and increasing life expectancy for as many as 7,500 bone marrow transplant patients in the U.S. annually.
The KIR/KIR-Ligand test was developed by Dr. Leung, Dr. Rafijul Bari and colleagues at St. Jude as part of their research to determine the impact of variations in the KIR2DL1 gene. The group focused on forms of KIR2DL1 carried by natural killer (NK) cells, special immune cells that kill abnormal cells such as cancer cells. Their research found that some forms of KIR2DL1 in NK cells are more active than others, and NK cells carrying the stronger form of KIR2DL1 can destroy cancer cells more effectively than the NK cells with the less active form.
A study conducted by Bari, Leung and colleagues that was featured in the September 16 online version of the Journal of Clinical Oncology (JCO) showed that patients were much more likely to survive a transplant and significantly less likely to experience disease progression when bone marrow transplants came from donors whose NK cells included the stronger form of KIR2DL1.
"The KIR/KIR-Ligand technology developed at St. Jude offers enormous potential to improve the lives of patients who receive bone marrow transplants, and we're looking forward to putting our assay development expertise to work to make it available for widespread clinical use around the world," said David Hout, PhD, Vice President of Research and Development at Insight Genetics. "With this assay, we have the ability to type multiple donor samples simultaneously and generate results rapidly, all at a reduced cost compared to existing screening methods. This test will not only increase the efficiency with which transplants are performed but it also promises to help dramatically improve cure rates by optimally matching each donor and recipient."
Under the terms of the agreement with St. Jude, Insight Genetics obtained the licensing rights to KIR2DL1 coding (cDNA) sequences and the KIR/KIR-Ligand Assay. Using its expertise in assay development, Insight Genetics initially will focus on refining the assay for clinical use, with plans to make it available to clinicians and researchers as a lab-developed test in early 2014. The company will be working to deepen relationships with bone marrow donor registry programs and transplant centers to enhance typing and donor matching for each procedure.
Insight Genetics' work on the KIR/KIR-Ligand Assay aligns with the company's expanding portfolio of advanced diagnostic tools to improve the lives of cancer patients. St. Jude previously licensed to Insight Genetics two other biomarkers, anaplastic lymphoma kinase (ALK) and a series of mutations within the ALK gene that confer resistance to ALK inhibitor therapy. The company is researching and developing additional tests to help physicians diagnose and monitor cancer patients and select the most effective treatments.
About Insight Genetics
Insight Genetics is a molecular diagnostics company with a mission of enabling precision medicine in the care of patients with cancer and other serious illnesses. The company's companion diagnostics detect specific biomarkers related to therapeutics that are currently in development or on the market for cancer or other diseases. Insight Genetics partners with leading academic researchers, pharmaceutical and biotechnology companies, clinical reference laboratories, and IVD kit manufacturers to provide new standards of care for patients with cancer and other life-threatening illnesses worldwide. www.insightgenetics.com.