A Diagnostics & Imaging Week

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 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 will 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. COG says that 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, said the project “demonstrates the critical role molecular diagnostics and biotechnology will play in our region.”

CMM said that 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.”

In other agreements:

• Accelr8 Technology (Denver) reported it has started joint research programs with Washington University School of Medicine (St. Louis) and the Denver Health and Hospital Authority to conduct preclinical studies to identify antibiotic resistance mechanisms using Accelr8’s patented analytical methods.

The company said its BACcel system, in development, will speed the diagnosis of infections in critically ill patients, particularly for healthcare-associated infections. Organisms targeted by the system include MRSA, pseudomonas, Acinetobacter, klebsiella, E. coli and related microbes.

The first phase of the work will replicate studies on Accelr8’s rapid MRSA identification method. Accelr8 scientists have already presented data that demonstrated the ability to rapidly identify difficult MRSA strains in a challenge collection provided by the Centers for Disease Control and Prevention (Atlanta).

The studies will expand the number of isolates (pure bacterial strains) used to statistically characterize Accelr8’s test performance. These new isolates will include organisms obtained from recent cases and will thus include strain variations that reflect current bacterial populations.

After fulfillment of the current agreements, the company said it plans to extend studies to additional test types.

David Howson, Accelr8’s president, said, “These preclinical studies will use laboratory instruments that allow rapid adaptation and upgrading as we proceed with product development. This plan will give us direct feedback from actual field experience as we integrate each additional test or engineering advance into the system.”

In December, Accelr8 reported that BD (Franklin Lakes, New Jersey) purchased an exclusive right to negotiate for a relationship to develop Accelr8’s BACcel rapid diagnostic platform.

• Genomic Health (Redwood City, California) is partnering 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.

• Jan Insulet (Bedford, Massachusetts) and DexCom (San Diego) said they have signed a development agreement to integrate DexCom’s continuous glucose monitoring technology into the wireless, hand-held OmniPod System Personal Diabetes Manager (PDM).

In addition to programming the patient’s insulin delivery, the PDM with integrated DexCom technology will receive and display continuous glucose readings from DexCom’s wearable sensor transmitter. Patients using the integrated system will have access to real-time glucose values and trended glucose information, as well as alarms to warn patients if glucose levels are rising or falling.