A Diagnostics & Imaging Week

Zetiq Technologies (Ramat Gan, Israel), a subsidiary of Bio-Light Life Science Investments, has reported the successful completion of a clinical trial to validate feasibility of early identification of cervical cancer.

The trial was conducted on cervical smears collected from 74 subjects at Meir MC and Macabbi health services in Israel.

The collected samples were processed with the advanced liquid based cytology method, and examined using three methods: staining with the traditional widely used Pap method, testing to identify the presence of the HPV virus that causes the disease, and staining with Zetiq's CellDetect method.

The testing utilizing the CellDetect technology has an average sensitivity of 90% to track and identify pre cancerous cells, and a specificity of 74%. This sensitivity was found to be higher then the sensitivity of the traditional Pap test, routinely used today with more than 300 million tests conducted worldwide, and similar to that of the test for HPV, the virus that can under certain circumstances cause the disease.

The specificity of the company's test was similar to that of the Pap test and "significantly higher" than that of the HPV test, Zetiq said.

Dr. Adi Elkeles, CEO of Zetiq Technologies, said, "We have successfully completed this important milestone, which demonstrates the company's ability to develop a simple and effective diagnostic tool for early identification of cervical cancer."

He added, "The results of this trial complement the previous successful trial completed earlier this year for the identification of cervical cancer in biopsies. The combined results show that Zetiq has complementary products able to screen as well as diagnose cervical cancer, offering high detection accuracy with a cost-effective process. These clinical findings attest to the range of applications for the company's technology."

Cervical cancer is the second-leading cause of cancer in women worldwide, with early identification of the disease greatly increasing the survival rate.

The screening methods currently available for the disease have succeeded in reducing mortality rate in the Western world, where performed, but the company noted that their error rate is high and the cost of follow-up tests is substantial. It said the error rates of the Pap test in screening reach 30% to 50%.

Dr. Ami Eyal, CEO of Bio-Light, said, "The results of this trial confirm that Zetiq has the potential to develop novel and effective products for early diagnosis of cervical cancer and probably other indications. The company plans to complete the development of its product for screening to early identify cervical cancers, and to proceed towards international collaborations and product commercialization."

DxS to build companion test unit

DxS Ltd. (Manchester, UK) has agreed to develop a diagnostic test device for Boehringer Ingelheim (BI; Ingelheim, Germany) to identify mutations of the epidermal growth factor receptor (EGFR) for patients with lung cancer.

DxS EGFR companion diagnostic, a real-time polymerase chain reaction (PCR) assay that detects mutations in the EGFR gene, will be designed as a companion test kit for BI's companion BIBW 2992 compound, branded as Tovok.

The DxS diagnostic is expected to be available in 3Q09 in time for Boehringer Ingelheim's multi-center Phase III clinical trial for Tovok.

BIBW 2992 is a novel tyrosine kinase inhibitor that irreversibly blocks the EGFR /HER2 receptors that are believed to promote tumor growth.

Patients with mutations in the EGFR gene may be more likely to respond to a medication that targets these receptors, thereby allowing doctors to prescribe a more effective and individualized treatment.

Underscoring the theme of the annual meeting of the American Society of Clinical Oncology being held in Orlando, Florida, this week, Manfred Haehl, senior vice president for medicine at BI, said, "Personalized medicine will play an important role in selecting the most effective treatment for patients with cancer and the collaboration agreement with DxS can expedite our efforts for patient selection and to help to maximise treatment outcome with our medication."

For 2008, BI reported net sales of €11.6 billion ($16.35 billion) and spent 20% of net sales on research and development in its largest business segment, Prescription Medicines.

DxS in January expanded its sales and marketing support in North America to follow on an increasing demand for its tumour mutation detection tests.

New TB test launched in South Africa

Roche Diagnostics (Penzberg, Germany) reported the launch of a new tuberculosis test for South Africa, one of the countries with the highest prevalence of tuberculosis wordwide. The new kit detects different species of Mycobacterium from human sputum samples using the LightCycler 2.0 Instrument.

Roche said the diagnosis of tuberculosis in South Africa presently relies on smear microscopy and culture methods. Smear microscopy allows for direct detection of acid-fast bacilli (AFB) in the specimen and makes it possible to identify the most infectious patients.

Although it provides rapid results and is inexpensive, such testing, Roche said, is limited by its lack of sensitivity and specificity. Based on the advantages of the LightCycler system, Roche Applied Science South Africa has developed a LightCycler assay that overcomes these problems.

The LightCycler Mycobacterium Detection Kit was tested in extended analytical and clinical trials together with South Africa's National Health Laboratory Services and at University Hospital in Regensburg, Germany.

The company said the new test offers a number of advantages over current testing methods. "It enables differentiation between Mycobacterium tuberculosis, Mycobacterium avium, and Mycobacterium kansasii in a single polymerase chain reaction run, and provides laboratories with reliable, accurate and objective results within hours, significantly improving patient management. Replacing the AFB smear test will significantly reduce false negative results obtained by microscopy."

Roche said use of the new test will result in fewer cultures being performed, leading to significant improvements in turnaround times for the patient. The test sequence is convenient and easy to perform; the throughput of the system suits low, medium and high throughput sample sites.

"We are proud of our contribution in the battle against tuberculosis, which is really a plague in African countries," said Manfred Baier, head of Roche Applied Science. "Every patient should get exactly what he needs to be cured – this is Roche's basic idea of personalized healthcare. A fast, safe test result is the backbone of this concept."

Roche said it is evaluating which countries besides South Africa would also be suitable candidates for the test.

In other Roche Applied Science news, the organization reported the opening of a new Application Support Center (ASC) in Shanghai, China. Staffed with experts skilled in applying a broad range of technologies to a diverse range of life science research topics, the company said the center will serve researchers across the Asia-Pacific region in their daily work with technical advice.

In support of today's researcher needs, Roche said it is strengthening technical support, and bringing it both culturally and geographically closer to customers in the Asia-Pacific region. The objective is to accelerate projects of Roche customers.

Roche said in the near future, the ASC will expand by opening lab facilities, providing laboratory support for customers experiments and performing trainings and demos of Roche instruments.

MDS Nordion opens new plant in Belgium

MDS Nordion (Ottawa), a global provider of medical isotopes and radiopharmaceuticals used in molecular medicine, has reported the opening of a facility in Fleurus, Belgium, for the production of Glucotrace (fluorodeoxyglucose), a radiopharmaceutical used in positron emission tomography imaging.

PET imaging produces a 3-D image of functional processes in the body, such as brain activity, and is "a highly accurate and effective method of diagnosing disease and managing patient therapy," according to MDS Nordion.

The company said its new facility will provide timely supply of Glucotrace to hospitals throughout Belgium, France, the Netherlands, Luxembourg and Germany.

Company President Steve West said, "Our investment in this facility further demonstrates our commitment to address the growing demand for PET diagnostic imaging in targeted European regions, and provides the medical community greater service for their future patient care."

MDS Nordion said the PET imaging market "is the most rapidly growing area of nuclear medicine and procedures."

It said statistics from a recent Medical Options survey indicate PET examinations are on a rapid rise in Europe, and are expected to grow at a compound annual rate of about 20% through 2012.

"To help meet increasing demand, this Good Manufacturing Practices production facility will have three daily production runs and a customer service team available 24 hours a day, seven days a week," the company said.

"PET imaging is effective because it allows early detection of tumors, as well as assessment of therapeutic strategies," said Professor Roland Hustinx of the nuclear medicine department at CHU-Universite de Liege. "MDS Nordion's new facility will provide another source of supply of Glucotrace to existing and new medical facilities, thereby increasing the ability of healthcare practitioners to conduct this critical type of imaging."

Collaboration on cytology imaging

mtm laboratories (Heidelberg, Germany), a privately held diagnostics company developing in vitro diagnostics for cervical cancer early detection and diagnosis, and MetaSystems (also Heidelber), a maker of microscopic imaging systems worldwide, reported the signing of an agreement to co-develop a customized automated imaging system for use in conjunction with mtm's CINtec Cytology products.

The CINtec Cytology kit is a qualitative, immunocytochemical assay for the evaluation of p16, a biomarker indicative of the onset of cervical disease, and is available globally for the early detection and management of cervical cancer. CINtec Cytology visually stains cervical cells that are over-expressing the biomarker p16, which clinically correlates with the screened women who harbor underlying high-grade cervical disease.

The automated imaging solution that the two companies are now developing is targeted to achieve equal or better sensitivity and specificity compared to manual observation and evaluation of the cytology slides, but with a greater degree of efficiency. This will be done by adapting Metafer, a system developed by MetaSystems that offers a unique high performance slide scanning and imaging platform, to the specific needs for analyzing CINtec Cytology stained slides.

The agreement initially covers the co-development of the imaging system and will lead upon success to a co-promotion effort from both companies based on any successfully developed end product. The combined system that the two companies aim to develop should be a cost effective and highly efficient tool to assess large numbers of cytology slides to pinpoint those specimens showing over-expression of p16 in the context of cervical cancer early detection and diagnosis.

Bob Silverman, CEO of mtm laboratories, said, "MetaSystems offers very valuable tools for leveraging the well-established clinical utility of mtm's CINtec Cytology products in the early detection of cervical cancer. As a result we will together meet the market demand for automated solutions that have the potential to improve on current approaches to the early detection of cervical cancer"