A Diagnostics & Imaging Week

Lifeline Biotechnologies (Reno, Nevada) said it has been granted regulatory clearance for its MastaScope Mammary Ductoscopy System in China.

Jim Holmes, company chairman, said, “We have been working diligently for almost a year now on obtaining approval and are delighted that we are now able to commence our marketing effort in [that] country in earnest.”

Holmes said it has been reported that the incidence of breast cancer among Chinese women has been rising at a rate of at least 27% over the past decade, with some 40% of those diagnosed with breast cancer dying within five years because the cancer is already advanced at the time of diagnosis.

“We believe as the MastaScope can help in the early detection and diagnosis of cancer and other abnormalities of the breast,” he said.

Distribution of the MastaScope in China is being handled by Shanghai Science Medical Equipment Ltd., a subsidiary of International Medical Consulting Group (Dallas).

Other Lifeline Biotechnologies products, including the First Warning System for assisting in the early detection of breast cancer and the OvaScope for assisting in the early detection of ovarian cancer, are continuing to be developed by the company.

CE mark sought for CeMines lung cancer test

CeMines (Golden, Colorado) said that CeMines Estonia OU (Tallinn, Estonia), the European Union subsidiary of its CeMines International unit, has filed for CE- mark registration through Trial Form Support (Helsingborg, Sweden), its primary contract research organization partner for European regulatory initiatives.

CeMines is seeking EU clearance for clinical use of the company’s minimally invasive lung cancer-detection test, CellCorrect Lab. The company said CellCorrect LAb test kits are “an inexpensive way to detect altered autoimmunity and associated patterns of disease-related autoantibodies in the bloodstream.”

CeMines said it has conducted international clinical studies which demonstrated that “unambiguous and consistent patterns of specific antibodies have regularly proven their utility as composite biomarkers to differentiate and characterize cancer.”

The company uses a bioinformatics-based statistical analysis and pattern recognition application known as CeMines Molecular FingerPrinting, which evaluates cancer-related antibody patterns and their relevant statistical profiles. These data are presented in a “score format” that does not require subjective interpretation by physicians.

Roger Attick, CEO and president of CeMines, said, “Our integration of CellCorrect LAb and CeMines Molecular FingerPrinting technologies may soon establish CellCorrect as the most innovative, minimally invasive in vitro diagnostic modality available.”

Test maker eyes expansion in Europe

Zonda (Moraga, California), a privately held company that specializes in test products that serve the medical diagnostic, bacterial food testing and environmental surfaces testing markets, is preparing to expand its product lines into markets around the world.

CLX Investment (Temecula, California), which holds a 20% interest in Zonda, said the first major element of the expansion initiative is to bring the company’s self-contained diagnostic device for infectious diseases to markets throughout Europe. The device, which has been given a CE mark for professional and self-testing use, is marketed under the HandiLab name.

CLX said the product is superior to its competition due to its cost-effectiveness, ease of use, compact design, long shelf life, rapid results and comparable accuracy.

Some limited distribution of the HandiLab product already has occurred in Eastern European countries, and CLX said it is assisting Zonda to secure distribution for all of Europe.

CLX said it also would provide help in gaining State Food and Drug Administration approval in China and FDA approval in the U.S. It said a U.S. patent is pending and added that Zonda is pursuing patent protection for international markets.

“We are preparing for broader distribution of the HandiLab-C test for chlamydia in Europe,” said Tammy Dunn, CEO of CLX Investment. “We believe that Zonda will finalize terms with distribution partners in Europe within days, and distribution deals in both China and the U.S. are planned once the proper regulatory approvals are finalized and suitable distribution partners are in place.”

Calypte HIV test gets nod in Malaysia

Calypte Biomedical (Lake Oswego, Oregon) said it has received notification that Aware BSP, its rapid blood test for HIV-1 and HIV-2 antibodies, has been successfully evaluated by government agencies in Malaysia and that it will work with Belantara Sains Teknologi, its Malaysian distributor, to commercially launch the product in that country.

Aware BSP is a 20-minute rapid test designed to detect HIV antibodies in whole blood, serum or plasma. It is one test in a line of three such assays, the other two being designed to detect HIV antibodies in oral fluid and urine. The company said health authorities in Malaysia have not evaluated non-blood HIV tests in the past, and are determining how such evaluations should be undertaken.

Malaysia, with a population of roughly 24 million, has an estimated 55,000 HIV infections.

MSI appoints distributor in Dubai

Medical Services International (MSI; Edmonton, Alberta) said it has appointed a distributor for Dubai and that an initial order of 50,000 VScan HIV test kits has been placed and payment terms agreed to.

Based on market studies, the company said it anticipates that it will ship more than 500,000 kits to the Middle East in the next 12 months. It said that in addition to the VScan HIV test kit, there has been significant interest in the VScan TB test kit.