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MDx/CDx Focus: NeoGenomics Launches NeoType for CLL; Results for Interleukin's PST Test; and More


NeoGenomics Launches Test to Gauge SF3B1 Mutations, Track Chronic Lymphocytic Leukemia Progression

NeoGenomics has launched a molecular test, called the NeoType Prognostic Panel for Chronic Lymphocytic Leukemia, which gauges mutations in the SF3B1 gene associated with disease progression.

The company will market the prognostic panel as a single test, as well as in conjunction with a new comprehensive prognostic profiling panel for patients with CLL. In addition to the SF3B1 mutation assay, the CLL Profile panel includes assays for IgVH mutation analysis, ZAP-70 expression measured by flow cytometry, and FISH tests targeting abnormalities of genes associated with the disease.

Studies have shown SF3B1 mutations to be linked to an aggressive form of CLL as well as to progression of myelodysplastic syndrome.

CLL, a disease that comprises around 30 percent of the 47,000 new leukemia cases diagnosed in the US annually, "can have significantly different severity depending on the genomic makeup of the leukemic cells," Maher Albitar, NeoGenomics' chief medical officer, said in a statement. "Many patients with the disease may go on with their life without needing any therapy, but in some patients the disease may progress rapidly."

With the NeoType panel for CLL, NeoGenomics is hoping to provide doctors with additional prognostic information so they can discern which patients need to be treated more aggressively.

NeoGenomics already markets five other NeoType tests as tools for characterizing breast, gastric, colorectal, lung and other solid tumors. These indications were launched in mid-July. "The NeoType CLL Profile is the company's first hematology profiling test panel," the firm highlighted.

NeoGenomics will market the test out of its CLIA-certified labs. In addition to operating a lab in Fort Myers, Fla., where the company is headquartered, NeoGenomics also has labs in Nashville, Tenn.; Irvine, Calif.; and Tampa, Fla.

According to the company's website, the NeoType platform uses Sanger sequencing to analyze exons in oncogenes, tumor suppressors, kinases, and other cell-signaling genes. The test platform can assess fresh tissue samples as well as formalin-fixed paraffin-embedded tissue.

Interleukin Announces Preliminary Results from Large Study for PST Genetic Panel

Interleukin Genetics earlier this month announced top-line results from the Periodontal Disease Prevention Study, data from which will further establish the clinical validity of its PST genetic risk panel to discern whether patients are at low or high risk of severe gum disease and significant tooth loss.

Preliminary results from the 5,400-patient study being conducted by the University of Michigan School of Dentistry show that for patients the PST panel identified as at low risk for gum disease, researchers found a statistically non-significant difference in their need for preventative care if they had two dental checkups per year or one. During a 16-year monitoring period, nearly 14 percent of patients who got two annual checkups had tooth extractions, compared to around 16 percent for those who visited the dentist once a year.

For patients whom the test deemed at high risk for gum disease, "two preventive visits per year significantly reduced the percentage of patients who had extractions … compared to one preventive visit per year" during the monitoring period, Interleukin said in a statement announcing the study results. Among high-risk patients who visited the dentist twice annually, nearly 17 percent had tooth extractions compared to 22 percent who had only one checkup.

"There was also a positive relationship between number of risk factors and the percentage of patients with extractions," the company reported. The low-risk subset, comprising 47 percent of study subjects, were non-smokers, had a molecular profile that placed them at low risk for gum disease as determined by the PST panel, and had no history of diabetes. High-risk patients, on the other hand, in addition to having positive test results by PST, were smokers or had diabetes.

Currently, it is standard practice to recommend that people visit their dentist every six months for an examination and cleaning. "However, the data from this study appears to question the every six months, one-size-fits-all model for preventive dental visits for adults in a low-risk population," said Interleukin CEO Lewis Bender in a statement. "These results support movement towards more personalized preventive measures for the management of periodontal disease in low-risk individuals, while encouraging more preventive care in high-risk patients."

The Periodontal Disease Prevention Study was led by William Giannobile, director of the Michigan Center for Oral Health Research at U-M. Researchers identified patients for the study through a large dental claims database. Interleukin has been marketing PST as a lab-developed test since 2003. Quest's Oral DNA group holds a non-exclusive license to market the test.

Interleukin has been working closely with several dental insurance firms to finance the development and commercialization of PST. These insurers are interested in the test's potential to reduce healthcare costs by identifying which patients can forgo two dental visits since they are at low risk for gum disease.

Nationwide dental insurance firm Renaissance Health Service is funding the validation study. Additionally, Delta Dental Plan of Michigan purchased 500,000 shares of Interleukin's preferred stock earlier this summer and Interleukin plans to use the $2.7 million net proceeds from this transaction to further commercialize PST (PGx Reporter 7/3/2012).

Quintiles Deepens Personalized Medicine Footprint with Expression Analysis Acquisition

Quintiles last week announced its acquisition of genomic testing and analysis firm Expression Analysis.

With the acquisition, Quintiles is hoping to help its customers apply genomic technologies to improve their understanding of diseases, develop diagnostic tools, and advance molecularly targeted personalized drugs. Quintiles, a contract research organization, said in a statement that the Expression Analysis acquisition was "the latest in a series of acquisitions and alliances" in the genomics applications realm.

Quintiles didn't reveal the financial terms of its acquisition of Expression Analysis.

Expression Analysis, which employs around 77 people, provides genomics testing and analysis services to biopharmaceutical firms, academic organizations, and government and non-profit entities. The company, based near Research Triangle Park, NC, last year began marketing its genomics and bioinformatics services through an offering called "Genomic Know-How."

Expression Analysis' genomic testing capabilities include gene expression profiling, genotyping, sequencing, nucleic acid isolation, data analysis for gene expression, next-generation sequencing, and proficiency testing for microarray assays. The firm performs its testing services in a CLIA-registered laboratory that is compliant with Good Laboratory Practices.

"The addition of Expression Analysis' Genomic Know-How to Quintiles is another step forward in our efforts to bring personalized medicine into mainstream drug development," Thomas Wollman, senior VP of Quintiles Global Laboratories, said in a statement. "Its expertise in genetic sequencing and advanced bioinformatics is essential to understanding diseases and drugs at the molecular level."

As part of Quintiles, Expression Analysis can hope to expand its customer base and begin marketing its genomics services globally. Quintiles supports clinical trials conducted in the US, Europe, South Africa, India, China, Singapore and Japan, as well as in a coordinated network of affiliate labs in Argentina and Brazil.

In acquiring Expression Analysis, Quintiles is delving deeper into the personalized medicine space. Two years ago, Quintiles partnered with molecular diagnostics firm Dako to develop personalized medicine products together. The companies' first project under the non-exclusive alliance is to support AstraZeneca's development program of an undisclosed cancer compound (PGx Reporter 11/3/2010). Dako was acquired by Agilent Technologies in June.

The same year, Quintiles and London Genetics said they would work together to provide personalized medicine services to drug developers. The company also has a partnership with Biomoda, an Albuquerque, NM-based cancer diagnostics firm, to refine the use of Biomoda's cytology-based screening technology to detect early-stage lung cancer (PGx Reporter 11/30/2011).