A Diagnostics & Imaging Week

Molecular diagnostics firm Epigenomics (Berlin), a developer of tests based on DNA methylation, confirmed that free-floating DNA gleaned from blood is a key to early detection of colorectal cancer.

Epigenomics showed that presence of the methylated form of DNA encoding the so-called Septin 9 gene is found in plasma of up to 57% of patients with all stages of colorectal cancer at high levels of specificity (95%). Data from the studies were presented at the American Association for Cancer Research (Philadelphia) meeting in Washington.

"The presence of methylated Septin 9 DNA in blood is a marker suited as an excellent population screening tool to identify a large number of asymptomatic cancers," said Catherine Lofton-Day, PhD, vice president of Molecular Biology at Epigenomics. "Our study is the first of this magnitude and with this level of clinical performance to describe a DNA methylation-based blood test for the early detection of colorectal cancer. A blood-based screening assay will be more patient-friendly than the conventional colorectal cancer screening tool, which requires patients to collect and submit fecal samples for fecal occult blood testing – a considerable obstacle to patient compliance."

The data presented come from two independent studies that determined Septin 9 levels in a total of 1,500 patients in three distinct categories. One group was known to be free from colon cancer after examination by colonoscopy. A second group included individuals with non-colorectal cancers and other non-cancerous conditions, and a third group consisted of patients with a confirmed diagnosis of colorectal cancer.

Positron positions for Canadian trials

Positron (Houston) reported that it has received approval from Health Canada to use its mPower PET scanner in oncology and cardiology clinical trials in that country. Positron said it is developing a broad range of applications and upgrades to its mPower line and "will be rapidly expanding the approved uses of its mPower product in Canada."

Positron said it is positioning itself to take advantage of the Health Canada approval by offering its mPower product to Canadian healthcare providers as a more cost-effective solution to the more traditionally expensive PET and PET/CT products now available in the marketplace.

Joe Oliverio, president of Positron, said: "We believed for a long time that the Canadian market would be ideal for widespread use of PET scanning since many studies have shown to reduce overall healthcare expenditures to the government payers while improving patient outcomes."

Chembio test recommended in Kenya

Chembio Diagnostics (Medford, New York) reported that its HIV 1/2 STAT-PAK and HIV 1/2 STAT-PAK Dipstick tests have been recommended for use in Kenya. Both tests were evaluated by the National AIDS/STD Control Programme of the Kenyan Ministry of Health and met their sensitivity and specificity requirements. The approval allows Chembio to begin selling its products in the country.

Under the U.S. administration's $15 billion Emergency Plan for AIDS Relief, the U.S. government plans to provide Kenya with $208 million in 2006 to support Kenya's fight against HIV/AIDS. This will include a significant scale-up of rapid testing programs.

Chembio has also appointed SAI Pharmaceuticals (Nairovi, Kenya) to distribute its rapid HIV tests in Kenya.

MedMira gets HIV test order from UAE

MedMira (Halifax, Nova Scotia), a provider of rapid diagnostic solutions, said it has received an order for 10,000 MiraWell Rapid HIV Tests from its Middle East distributor, Spree Trading (Dubai), a member of Shawwa Group International (Cairo, Egypt).

The tests are destined for the Dubai, United Arab Emirates (UAE), market, where they will be sold to immigration services, hospitals and other healthcare facilities providing rapid HIV testing. The company said MiraWell HIV is the fastest flow-through rapid HIV test in the world, providing results "instantly."

MedMira completed the registration process for the tests with the UAE Ministry of Health last year. It said Spree will pursue further product evaluations, tender opportunities and new sales channels for the company's products.

MedMira said new market opportunities for other MedMira products include an over-the-counter rapid HIV test and rapid test for HIV/hepatitis C co-infections.

Agendia, GeneCare in distribution pact

Agendia (Amsterdam, the Netherlands) and GeneCare of South Africa reported reaching an agreement for distribution of Agendia's MammaPrint and CupPrint products in South Africa.

MammaPrint uses a 70-gene profile to classify breast cancer patients as 'low' or 'high' risk of developing distant metastasis in a 10-year period. MammaPrint therefore offers additional information to oncologists and patients concerning the subsequent treatment plan.

CupPrint test is intended for cancer of unknown primary patients. For these cases finding the primary tumor and therefore providing most appropriate treatment is difficult by conventional techniques, according to AGendia. In contrast, CupPrint identifies the primary tumor which aids in finding the best treatment with the objective of increasing life expectancy and reducing chemotherapy's side effects.

Biosite, OGeS in blood test R&D accord

Biosite (San Diego) and privately-held Oxford Genome Sciences (OGeS; Oxford UK) have collaborated to evaluate protein-based disease markers for colorectal cancer for the development of blood-based tests. The tests would be aimed at providing, the companies said, "personalized" therapeutic options for colorectal cancer. In particular, the blood-based diagnostics would enable early identification of colorectal cancer patients that have relapsed, thus enabling selection of the most appropriate therapies.

OGeS has developed the Oxford Genome Anatomy Project, a database that integrates genomic, proteomic and clinical information derived from blood and tissue studies. In the collaboration, OGeS will identify at least 25 proteins discovered in blood and tissue samples from relapsing colorectal cancer patients, with Biosite having the rights to develop blood-based tests using one or more of those biomarkers. Financial terms of the agreement were not disclosed.

Patients with a primary diagnosis of colorectal cancer are followed up on average every three to six months for the first three years and every six months for the next two years to assess recurrence.