A Diagnostics & Imaging Week

Correlogic Systems (Bethesda, Maryland) reported a research collaboration with the Uniformed Services University of the Health Sciences (USU; also Bethesda) and the Henry M. Jackson Foundation for the Advancement of Military Medicine (Rockville, Maryland).

Under the agreement, USU's Center for Prostate Disease Research (CPDR) and the foundation will collaborate with Correlogic on a study of up to 2,000 men with specified prostate cancer conditions in order to expand research on the company's protein pattern recognition approach and technology in prostate cancer.

Correlogic said the agreement provides for two concurrent studies.

The first will expand the company's research on the use of its "hidden patterns" approach and ProteomeDx pattern recognition technology to the detection of prostate cancer. The goal is to develop a more effective blood test for the detection of prostate cancer.

The company said the current prostate-specific antigen (PSA) test is most accurate for men whose PSA levels are outside the 2.5-10 ng/ml range. It noted that men whose PSA levels are within the 2.5-10 ng/ml "gray zone" frequently undergo prostate biopsies, although some 75% are ultimately determined not to have prostate cancer. "For these men a blood test that is a more accurate indicator could reduce the need for painful, invasive and costly procedures," Correlogic said.

The second study will center on men undergoing radical prostatectomies to determine whether the company's approach and technology can be extended to distinguish between indolent and aggressive prostate cancer.

It said that because most cases of prostate cancer are slow-growing, and life quality effects of prostate cancer treatment can be a concern, "distinguishing whether a prostate cancer is aggressive is highly important in determining the extent or necessity of treatment." Currently there is no effective prospective test for determining the aggressiveness of prostate cancer in most men, the company said in a statement.

Dr. Shiv Srivastava, scientific director of the Center for Prostate Disease Research, said, "The goal of this combination of the technology and research capacity of Correlogic and the CPDR is improved diagnosis and treatment of prostate cancer. Because of the prevalence of prostate cancer, a prognostic blood test would be an important development to all men."

The American Cancer Society (Atlanta) estimates that more than 232,000 men in the U.S. will be diagnosed with prostate cancer this year and that about 30,350 men will die of the disease. It says that one in six men will be diagnosed with prostate cancer during their lifetimes.

Correlogic Systems is focused on the development and application of pattern recognition in disease detection. It has developed technology and processes with a variety of applications for biomarker discovery, disease detection and new drug discovery. The initial application has been in the field of proteomics, with concentration on the early detection of prostate, ovarian, breast and other cancers.

In other grants/contracts news:

Atom Sciences (Oak Ridge, Tennessee) was awarded a $100,000 Small Business Innovative Research grant from the National Institutes of Health's (Bethesda, Maryland) Institute of Allergy and Infectious Diseases to develop a diagnostic tool for tuberculosis.

Atom Sciences said the diagnostic method, called Limited Primer Extension, or LPE, can screen clinical samples for the bacterium that causes tuberculosis. It also can test, at the same time, for related infectious agents that cause tuberculosis-like symptoms.

Dr. Richard Hurt, inventor of the technology and staff research scientist at Atom Sciences, will head the project. He said, "Current molecular diagnostic kits for TB detection identify only whether the TB pathogen is present or absent. They don't provide any information about the cause of TB-like symptoms if the TB pathogen is absent. LPE provides this additional information and therefore reduces the overall cost of treatment."

Dr. Tom Whitaker, president and CEO of Atom Sciences, emphasized that there are many other applications of the LPE technology besides TB testing, some with ramifications for homeland security. "LPE technology can identify bacterial or viral sources of infection for many diseases," he said. "The capability to simultaneously test for a large number of pathogens makes it ideal for use by first responders in the case of a bioterrorist attack."

Molecular Pathology Laboratory Network (MPLN; Maryville, Tennessee), a clinical diagnostics reference laboratory, provided the needed clinical evaluation of the LPE technique and assisted in writing the proposal to NIH.

Dr. Neil Quigley, director of research and development at MPLN, noted that an important aspect of the LPE technology is cost savings. "One of the reasons MPLN is interested in LPE applications is their potential to reduce the costs of clinical diagnostic testing. This innovative process could yield a substantial cost savings in both clinical diagnostics and in overall healthcare costs paid by providers and patients."

Cardiology Associates (Mobile, Alabama), a 25-physician cardiology group, has installed the GE LightSpeed Volume CT (VCT) Scanner from GE Healthcare (Waukesha, Wisconsin).

The LightSpeed VCT is the world's first volume CT system. It is able to non-invasively capture the image of any organ in one second, perform a whole body scan in fewer than 10 seconds and capture images of the human heart in fewer than five heartbeats.

In a single rotation, the LightSpeed VCT system creates 64 images of the heart, totaling 40 mm of anatomical coverage. Those images are combined to form a 3-D view of the patient's anatomy for a physician to analyze. The LightSpeed VCT can attain 43 millisecond temporal resolution, which means doctors can effectively "freeze" the motion of the heart, helping to ensure a highly accurate representation of the human heart and arteries.

"Historically, heart motion has made cardiovascular CT scans challenging," said Dr. Gerry Phillips, president of Cardiology Associates. He said that the rapid action and multiple images inherent to LightSpeed VCT "could become the greatest revolution in cardiovascular care since the diagnostic heart catheter."

MicroFluidic Systems (MFSI; Pleasanton, California) has signed a cooperative research and development agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID; Fort Detrick, Maryland) to evaluate the company's pathogen sample processing technologies and products.

MFSI said it has been awarded several prime contracts from the U.S. government, including one from the Department of Homeland Security's Homeland Security Advanced Research Projects Agency to develop a Bioagent Autonomous Networked Detector system.

One of the components of this automated pathogen detection system is MFSI's cell lysis technology, which has been developed into a stand-alone commercial laboratory instrument called the BioLyser.

USAMRIID is one of several entities working with MFSI to provide initial user feedback on the product, the company said.

MFSI was founded in 2001 and is focused on the development of automated microfluidic systems for biological assays.

Genzyme (Cambridge, Massachusetts) said it has entered a license agreement with Massachusetts General Hospital (MGH; Boston) and the Dana-Farber Cancer Institute (also Boston) to obtain exclusive, worldwide diagnostic rights to their discovery of gene mutations recently found in some patients with non-small cell lung cancer.

The presence of these mutations, or markers, discovered in the epidermal growth factor receptor (EGFR) gene, has been shown to correlate with clinical response to certain drugs used in treating non-small cell lung cancer. Through this license, Genzyme will develop and market a diagnostic test for the EGFR markers that can be used to help identify patients who are most likely to respond to targeted lung cancer therapies, including Tarceva (erlotinib) and Iressa (gefitinib).

Responses to these drugs have been found to be positive in those patients identified as having specific EGFR gene mutations, Genzyme said. Its new test is designed to identify patients with those specific EGFR gene mutations, predict the responses to those drugs found to clinically correlate with such mutations and, ultimately, help extend the lives of patients undergoing therapy.

Genzyme said it expects to launch its EGFR mutation test later this year.

The discovery of the EGFR mutations was made by researchers at Dana-Farber and MGH who analyzed tumor samples from lung cancer patients who had responded to tyrosine kinase inhibitors of EGFR. According to their published studies, the majority of patients who had the mutations responded to the therapy, while those who did not have the EGFR mutations did not respond.

"We are eager for this technology to be widely available to physicians and their lung cancer patients, as it can help identify those who are likely to dramatically respond and survive for extended periods of time with a relatively benign treatment," said Bruce Johnson, MD, director of the Lowe Center for Thoracic Oncology at Dana-Farber, who was involved in the discovery of the EGFR mutation.

Berlex (Montville, New Jersey), a U.S. affiliate of Schering AG (Berlin), said the company has been awarded a new contract by Premier (San Diego), a group purchasing organization, to provide contrast media for MRI to members of the Premier network.

The new contract extends the nearly decade-long relationship between the two companies. Under the terms of the agreement, Berlex will provide Premier members access to Magnevist (gadopentetate dimeglumine) Injection, a contrast media for enhanced MRI.

The value of the contract is estimated to be in excess of $40 million annually.

SourceOne Healthcare Technologies (Mentor, Ohio) and Shimadzu Medical Systems (Torrance, California) have signed a contract giving SourceOne rights to market and distribute a mobile X-ray system specifically manufactured by Shimadzu for SourceOne in the U.S.

SourceOne is a distributor of medical-imaging systems, equipment, radiographic consumable supplies, and services to healthcare facilities in the U.S.

Shimadzu Medical Systems makes a range of diagnostic systems that are used in all areas of clinical applications, including CT, digital subtraction angiography, cardiovascular systems, digital radiography and fluoroscopy systems, ultrasound and general radiography.

Shimadzu will manufacture the mobile X-ray unit for SourceOne, which will distribute the system nationally as the Mobile Star II. The Mobile Star II is a cordless mobile X-ray system designed to perform radiography examinations in remote locations away from a traditional radiography department.