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Insight Genetics Licenses Bone Marrow Transplant MDx from St. Jude Children's

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Insight Genetics this week announced an exclusive, worldwide licensing deal with St. Jude Children's Research Hospital for a genetic test to improve donor matching in bone marrow transplants.

Insight will license St. Jude's KIR/KIR-Ligand Assay, which has been shown to prevent the recurrence of cancer in transplant recipients and to reduce the risk of death following bone marrow transplantation by about 60 percent, the company said.

The KIR/KIR-Ligand assay is a qPCR-based SNP assay that is compatible with any commercial qPCR platform. It was developed by Wing Leung, Rafijul Bari, and others in St. Jude's Department of Bone Marrow Transplantation and Cellular Therapy as part of research into the impact of variations in the KIR2DL1 gene.

The group focused on forms of KIR2DL1 carried by natural killer 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 can destroy cancer cells more effectively than those with the less-active form.

Insight has obtained the licensing rights to the KIR2DL1 coding sequences and the KIR/KIR-Ligand Assay. In the immediate term, the Nashville, Tenn.-based firm will refine the assay for clinical use and plans to make it available to clinicians and researchers as a laboratory-developed test in early 2014.

Insight added that it will work to "deepen relationships with bone marrow donor registry programs and transplant centers to enhance typing and donor matching for each procedure."

Citing statistics from the US Health Resources and Services Administration, Insight said that more than 18,000 Americans are diagnosed each year with life-threatening illnesses for which bone marrow transplants are the best treatment option. The KIR/KIR-Ligand Assay may be able to assist in improving donor matches and increasing life expectancy for as many as 7,500 bone marrow transplant patients in the US each year, it said.

Insight previously licensed two other biomarkers from St. Jude's — anaplastic lymphoma kinase, and a series of mutations within the ALK gene that confer resistance to ALK inhibitor therapy (PCR Insider 12/23/2010).

Last October, the company won a contract from the National Cancer Institute worth nearly $1.5 million to begin clinical testing of its qPCR-based ALK mutation assay, ALK Screen, in lung cancer (PCR Insider, 10/11/2012).