A Diagnostics & Imaging Week

Cytyc (Marlborough, Massachusetts) said last week that it has placed the first ThinPrep Imaging System in the UK at The Doctors Laboratory (TDL; London). TDL is the largest clinical pathology service in the independent healthcare sector in the UK.

The TDL contract with Cytyc UK Ltd. is for a term of five years, and represents a potential of about 200,000 imaged ThinPrep Pap tests during that period.

The Doctors Laboratory's pathology service provides a wide range of diagnostic tests for general practitioners, consultants, clinics, hospitals, speciality and screening companies, occupational health departments, insurers, pharmaceutical product trials and laboratories, as well as esoteric test referrals from Central London and throughout the UK.

TDL introduced the ThinPrep Pap test to its clientele in June 2000 and provides a rapid cervical cytology service to its customers by consistently reporting test results within 48 hours.

"We are pleased to be Cytyc's first UK site to implement the ThinPrep Imaging System," said David Byrne, CEO of The Doctors Laboratory. "This enables TDL to further improve [our] commitment to quality and speed of service in this key area of diagnostics."

Colin Clelland, MD, consultant pathologist at TDL, said, "We have found the ThinPrep Imaging System to be a reliable and beneficial aid for rapid, accurate interpretation of ThinPrep cervical cytology. It has ... improved workflow significantly."

TDL became part of Sonic Healthcare, one of the world's largest clinical pathology companies, three years ago. Sonic has laboratories in Australia, Germany, New Zealand and the UK.

French firm to distribute Mesomark test

Fujirebio Diagnostics (FDI; Malvern, Pennsylvania), an oncology testing leader, and Cisbio international, a French biotechnology company, reported a distribution agreement for European distribution of FDI's new Mesomark blood test for mesothelioma.

This agreement, the second for FDI, continues the worldwide commercial rollout of Mesomark. FDI launched the test in Australia earlier this year.

Mesothelioma is a highly aggressive form of cancer in which fluid accumulates between the lining of the lungs and chest cavity. It is primarily caused by work-related asbestos exposure and has an average latency period of up to 75 years. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries, and recent epidemiological studies predict an increase in that number in the next few decades.

Until now, there have been no reliable serum tumor markers for mesothelioma, which means that diagnosis, screening and monitoring responses to treatment have been difficult. Mesothelioma also is notoriously resistant to chemotherapy and radiotherapy, and is rarely cured by radical surgery.

Mesomark, a manual enzyme-linked immunosorbent assay for managing mesothelioma, works by identifying a group of molecular markers called soluble mesothelin-related proteins, which are released into the bloodstream by mesothelioma cells.

Cisbio international, a subsidiary of Schering SA, manufactures assays for the quantification of tumor markers and other biomarkers in clinical biology.

Fujirebio Diagnostics specializes in the development of in vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

Skin test device approved in China

Greer (Lenoir, North Carolina) reported receiving approval from China's State Food and Drug Administration for the GreerPick Skin Testing System. The GreerPick system, which the company said is used by more allergists in the U.S. than any other single-site skin test device, becomes the first device of its kind registered in China.

Skin testing is a primary tool for the diagnosis of inhalant allergies. The company said use of the GreerPick test provides "a very reliable and efficient method of skin testing." It said the easy-to-use system is designed to protect skin test technicians from accidental needlesticks.

"We are very excited about the approval of the GreerPick in China because it gives Greer entry into one of the fastest-growing markets in the world," said William Mahoney, director of source materials. "Currently most skin testing in China is performed by the intradermal method and the use of the GreerPick will allow skin testing to be performed much more quickly and safely."

Greer is a provider of allergy immunotherapy products and services.

Oxford researchers cite MassArray QGE

Sequenom (San Diego) said researchers at the Wellcome Trust Center for Human Genetics at the University of Oxford (Oxford, UK) successfully completed testing of the MassArray Quantitative Gene Expression (QGE) application.

The findings were reported in Analytical Biochemistry. The article demonstrated the ability to measure nucleic acid abundance, a process that allows scientists to gain a better understanding of the expression level of genes and how various disease states, treatments and cell stimuli change those levels.

The MassArray QGE procedure is known as real competitive polymerase chain reaction and consists of competitive PCR in conjunction with MALDI-TOF mass spectrometry to determine nucleic acid levels within a sample.

The Oxford researchers also developed a statistical analysis tool, TITAN, designed for competitive PCR applications.

The study demonstrated that MassArray QGE delivers data with a high level of concordance to real-time PCR (RT-PCR), the current "gold standard" for gene expression analysis. The researchers also said that MassArray QGE provides greater sensitivity and needs less individual assay optimization compared to RT-PCR.

Second CTLM system for Polish center

Imaging Diagnostic Systems (Fort Lauderdale, Florida) said it would fulfill a request by the Maria Sklodowska-Curie Memorial Institute in Poland to install a second CT Laser Mammography (CTLM) system for clinical research.

The initial system was installed in January and patient volumes at the institute have continued to increase, the company said.

The CTLM system uses laser technology and proprietary algorithms to create 3-D cross-sectional images of the breast.