A Medical Device Daily

The Center for Molecular Medicine (CMM; Grand Rapids, Michigan) said it has been selected by the Children’s Oncology Group (COG; Arcadia, California) to provide professional genotyping services and analysis as part of a study to evaluate the existence of genetic abnormalities and their association with response to therapy and specific toxicities to improve the diagnosis and treatment of childhood leukemia.

In Phase I of the study, the CMM has been asked to provide extensive testing and review of up to 2,200 matched samples of DNA from pediatric leukemia patients’ germline blood samples and their leukemic blasts. The CMM said it would identify and catalog potentially critical differences it finds across these DNA samples for analysis and subsequent use by COG.

Once these genetic differences are identified, COG researchers will have information that can be adapted to improve diagnostic testing and zero in on methods to evaluate personalized therapeutics. According to the COG, acute lymphoblastic leukemia is the most common form of cancer in children, with 3,000 new cases diagnosed in the U.S. each year.

CMS is a CLIA-certified clinical diagnostic laboratory, founded early last year.

Matt VanVranken, chairman of the CMM board of directors, said the project “demonstrates the critical role molecular diagnostics and biotechnology will play in our region.”

CMM testing of COG project samples will begin this month, the organization said, and Phase I may be completed as early as this spring. COG and CMM are working together to identify sources of funding to expand the study to six to eight thousand more specimens.

CMM Executive Director Daniel Farkas, PhD, said the sample testing and analysis would focus on tiny variations found within human genomes, including naturally, DNA from leukemic specimens. A genome is the complete DNA sequence present in every cell of an organism.

“The location of naturally occurring variations in human DNA, known as single nucleotide polymorphisms (SNPs), serve as signposts or markers in the genome. Associating these SNP markers with diseases in different individuals provides opportunity for highly specific diagnostic tests, and, even more exciting, provides insights into what genes may be involved in the disease process. This insight can lead to highly targeted and specific therapies,” Farkas said. “In the COG study, the CMM will identify and catalog about a million key SNPs in these DNAs from childhood leukemia patients so that the COG can move forward in its important work uncovering new approaches to identifying and combating this disease.”

According to the COG, progress in the treatment of acute lymphoblastic leukemia (ALL), the most common malignancy of children, is one of the leading success stories in all of cancer research and cancer care. The survival rate has risen from about 15% to 85% over the past four decades.

“As the national infrastructure for pediatric cancer clinical and translational research, the COG is uniquely positioned to leverage its unparalleled, highly annotated bio-specimen resources to identify and validate specific gene polymorphisms which can then be prospectively utilized to select specific anti-leukemia therapies with the highest likelihood of success and with the lowest potential for acute and long term toxicities associated with therapy,” said Gregory Reaman, MD, chair of COG and professor of pediatrics at George Washington University School of Medicine and Health Sciences (Washington). This will be the largest study of this kind according to Reaman and the subsequent phase of this study will hopefully be accomplished by this partnership between COG and CMM, with support from its joint venture partners, the Van Andel Institute and Spectrum Health, as well as Affymetrix. n

In other agreements:

* Home Diagnostics (Fort Lauderdale, Florida) reported that it has signed an agreement to be the exclusive supplier of a co-branded blood glucose monitoring system for Rite Aid (Harrisburg, Pennsylvania) drug stores. Home Diagnostics’ TRUEtrack will be available as the TRUEtrack for Rite Aid blood glucose monitoring system at 5,000 Rite Aid stores across the U.S. starting in March.

TRUEtrack uses biosensor and chip coding technology to generate accurate results in 10 seconds from a single microliter of blood. The TRUEtrack meter and test strips typically cost up to 30 percent1 less than other systems and are covered by Medicare and most insurance plans.

* Genomic Health (Redwood City, California) has partnered with Pfizer (New York) on the development of a genomic test to estimate the risk of recurrence following surgery for patients with Stage I-III renal carcinoma, clear cell type that has not spread to other parts of the body.

The clear cell type of renal carcinoma is the most common type of kidney cancer in adults, affecting an estimated 25,000 people each year in the U.S. As part of the collaboration, the companies will apply the same molecular technology and clinical strategy Genomic Health used to develop its Oncotype DX breast cancer test.