A Diagnostics & Imaging Week

BioCurex (Richmond, British Columbia) said it has completed a study in which its Recaf blood test detected 92% of cervical cancers using a drop of blood. The specificity of the test was 95.7%.

The study included 25 cervical cancer blood samples and 69 normal blood samples, BioCurex said.

BioCurex's technology identifies a cancer marker known as Recaf, which is found on malignant cells from a variety of cancer types but is absent in most normal or benign cells.

The company said the National Cancer Institute (Bethesda, Maryland) reports a sensitivity of 55% to 88% for detecting high-grade lesions using a traditional Pap test.

The 2005 estimated market size for Pap smears is $1 billion for 2005. Currently, there is no commercial blood test available for the detection of cervical cancer.

BioCurex CEO Dr. Ricardo Moro said the findings "are in line with our previous results for detecting other types of cancers. The accumulation of positive results strongly suggests that Recaf is expressed by all types of cancer, thus lending additional support to the idea of using this cancer marker for routine cancer screening."

He added that a Recaf test performed on blood collected for other routine clinical analysis "would likely prove much cheaper than the traditional Pap test, which currently involves a gynecologist to extract the sample as well as a pathologist (or a sophisticated artificial intelligence system) to read the results."

Moro said another important application for BioCurex's blood test is "to improve the follow-up screening of patients who have been operated on for cervical cancer; recurrence of the cancer or its metastases could be detected early by periodically monitoring the blood levels of Recaf, thereby significantly enhancing the chances of patient survival."

Worldwide, cervical cancer claims around 190,000 lives annually, the company said, and is the third-most-common cause of cancer-related deaths.

Cancer study uses Agilent technology

Agilent Technologies' (Palo Alto, California) Human Genome CGH Microarray technology will be used by researchers at Peter MacCallum Cancer Center (Melbourne, Australia) in a three-year study designed to better understand mesothelioma, the company said.

Mesothelioma is a cancer found in the lining of the chest, the abdominal cavity and around the heart, usually caused by exposure to asbestos. Agilent noted that due to its active mining and manufacturing of asbestos in the mid-1900s, Australia has the highest incidence of mesothelioma in the world. Rates of the disease have tripled in the past 20 years and are expected to peak about 2010.

The company noted that diagnosis of this type of cancer is difficult, and patients often are not identified until the condition is "quite advanced."

Agilent said its new microarray techniques in comparative genomic hybridization (CGH) would allow researchers to "rapidly and reliably identify genetic changes in tumorous cells." The company said it is believed that specific genetic changes may accompany the onset and progression of the disease.

Dr. Andrew Holloway of the Peter MacCallum Cancer Center said his team will work in conjunction with colle-agues at the University of Western Australia (Perth), using Agilent's CGH microarray to provide a more thorough understanding of the genetic makeup of mesothelioma cells, which may ultimately lead to increased knowledge of the origins and development of this and other cancers.

"CGH technology will allow us to study the entire genome in a manner that hasn't been possible in previous genomics research," said Holloway. "Upon completion, this project will produce the largest data set of its kind on mesothelioma in the world. We are very optimistic that it will give us a much clearer understanding and interpretation of this devastating disease."

He added: "We hope the outcome of this work will have a major effect on mesothelioma research. The Australian economy will need $5 billion to fund the compensation, treatment and management of mesothelioma in the community, so this research is critical in working toward minimizing these costs, with the eventual hope of developing tools for earlier diagnosis and treatment."

David Tunks, product manager for integrated biology solutions at Agilent, said: "[Our] new CGH microarray platform provides very high sensitivity, enabling researchers to detect small changes in chromosomes, including single copy deletions, which have previously been the most difficult to find."

India lab firm works with Biomoda

Biomoda (Albuquerque, New Mexico) and Metropolis Health Systems (Mumbai, India) have entered into an agreement for Metropolis to provide clinical samples for Biomoda's diagnostic test development program.

Validation studies for Biomoda's products for the early detection and targeted treatment of specific cancers will be supported by the services of Metropolis Health Services, the largest independent pathology laboratory system in India.

"This represents a critical step as we accelerate development," said Biomoda President John Cousins, "initially as a major source of clinical sampling and as an ongoing international strategic alliance with our targeted customer base in a significant part of the world."

Metropolis Health Services has eight central laboratories, catering to the needs of more than 3,000 small laboratories, nursing homes, hospitals and more than 10,000 consultants, and processing more than 5 million samples per year.

Biomoda, a development stage in vitro diagnostics company, is focused on research, development and commercialization of cancer diagnostics. Its laboratory operations are situated at Kirtland Air Force Base in Albuquerque.

Nanogen, deCode in genomics agreement

Nanogen (San Diego), a developer of advanced diagnostic products, reported that it has entered into a supply and license agreement with deCode Genetics (Reykjavic, Iceland) to provide a new genomics assay for single nucleotide polymorphism (SNP) discovery, validation and screening.

"The products and assay that we will provide deCode represent our comprehensive product menu available from the recent merger of Nanogen and Epoch Biosciences," said Howard Birndorf, Nanogen's chairman and CEO.

The assay incorporates a range of Nanogen's products, including the Eclipse Dark Quencher, new DNA linker technology, modified bases and fluorescent dyes, and allows rapid SNP analysis on a large number of patient samples.

Nigerian contract for MSI test kits

Medical Services International (MSI; Edmonton, Alberta) said it has been awarded a $25 million contract from the government of Nigeria for the company's VScan HIV 1 & 2 test kits.

Nigeria recently issued a tender notice for eligible companies to submit proposals to supply its health sector with HIV test kits. That procurement contract was an up-shot of the $120 million loan recently awarded to Nigeria from the World Bank for improvement of the country's health, educational and agricultural sectors. Of the $120 million, $25 million was allocated for the supply of HIV/AIDS test kits.

The VScan HIV test kit had recently been awarded registration and approval in Nigeria.

MSI also reported that its VScan HIV and TB rapid test kits have been accepted for registration by regulatory authorities in Russia.

The company noted that the Doctors Without Borders organization had reported last month that development of simple and rapid diagnostic tools is the key to fighting tuberculosis. The organization said that TB would kill more than 8 million people this year, more than all other infectious diseases combined.

MSI said that it is receiving "increasing interest" in its VScan TB test kit, and that it expects to generate more than $12 million in TB sales kit sales per year.

The company's VScan rapid test kit is a single-use test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, Dengue fever, West Nile virus, syphilis and prostate cancer.