A Medical Device Daily

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.

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 rates 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%.

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."

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.