A Medical Device Daily

OrSense (Nes Ziona, Israel) reported receiving CE-mark approval for its NBM-200G non-invasive continuous blood glucose monitor.

The NBM-200G is based on OrSense's proprietary technology that allows non-invasive measurement of analytes, including glucose, hemoglobin, and oxygen saturation with very high sensitivity.

The device is operated by placing a ring-shaped probe around the patient's finger, which applies a gentle pressure to the finger, similar to that applied during blood-pressure measurement. Optical elements in the sensor perform a sensitive measurement of the light transmitted through the finger.

Called Occlusion Spectroscopy, this method provides a quick, accurate and painless measurement of the patient's blood glucose. OrSense said the method was tested on more than 400 patients and exhibited "comparable accuracy to invasive solutions, while providing superior ease of use and safety."

The NBM-200G also enables the identification of glucose trends and the detection of hypo- and hyperglycemic events and according to the company, "may also optimally answer the growing need for tight glycemic control in acute-care settings, thereby reducing morbidity and mortality."

Professor Avraham Karasik, director of the Institute of Endocrinology at Chaim Sheba Medical Center (Tel Hashomer, Israel), said, "We have been studying OrSense's non-invasive continuous monitoring device on a significant number of patients in a home-like environment and in acute-care settings. The device's performance is extremely robust and reliable, user compliance is very good with no adverse effects, and the results are promising."

"This is an important milestone for OrSense in the path for developing the first fully non-invasive glucose monitoring device," said Chairman Shimon Eckhouse, PhD. "This … will play a very significant role in improving the quality of life of millions of diabetic patients around the world."

OrSense said its non-invasive device is "poised to provide a dramatic improvement in the quality of care and quality of life of people with diabetes," allowing them to avoid the discomfort of traditional fingerstick-based methods.

An abstract containing data from clinical trails demonstrating the reliability of NBM-200G was accepted for a poster presentation titled "A Non-Invasive Prospective Continuous Glucose Monitoring System" during the 67^th scientific session of the American Diabetes Association (ADA) in Chicago, which begins today.

Abbott gets CE mark for HBV test

Abbott Molecular (Des Plaines, Illinois) and Celera (Rockville, Maryland) said that Abbott has received CE-marking for a real-time polymerase chain reaction (PCR) test for monitoring hepatitis B (HBV) viral load in patients, allowing the test to be marketed in the European Union.

Abbott is marketing the test under its alliance with Celera.

The Abbott RealTime HBV test, developed for use on the Abbott m2000 automated instrument system, is designed for the measurement of HBV in human plasma or serum from patients known to be infected with the virus. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing a patient's response to antiviral treatment.

With the addition of the HBV test, Abbott said the m2000 offers "the broadest menu of molecular tests available on a single instrument platform." The m2000 menu includes real-time PCR tests for HIV-1, hepatitis C, Chlamydia, and a combination test for chlamydia and gonorrhea.

Abbott said quantitative measurements of HBV levels in plasma or serum have been shown to be "an essential parameter" in the prognosis and management of patients with HBV. An initial measurement of HBV viral load can guide a decision to begin antiviral therapy, while monitoring HBV DNA levels during therapy can influence its duration and also signal the development of drug resistance.

The higher the baseline viral level, the more likely a patient is to develop hepatocellular carcinoma, a primary cancer of the liver.

"The Abbott RealTime HBV assay is the only test currently available that targets an essential, highly conserved segment of the HBV genome, which makes it a very reliable test for detecting and measuring all known HBV genotypes," said John Robinson, PhD, senior director, research and development, Abbott Molecular. "It gives physicians one of the most precise tests available to guide treatment decisions."

Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera. In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.

Celera is an Applera (Norwalk, Connecticut) business. Its molecular diagnostics business uses proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and the company is developing diagnostic products based on these markers as well as other known markers.

Genesis gets added Mammastatin patent

Genesis Bioventures (Los Angeles) said that Mammastatin, the breast cancer marker exclusively licensed to the company by the University of Michigan (Ann Arbor), has been granted an additional patent from the European Patent Office for diagnostic and therapeutic uses.

The Mammastatin technology is developed for use as the Mammastatin Serum Assay (MSA), a breast cancer risk assessment test developed by Genesis Bioventures' Biomedical Diagnostics subsidiary.

Douglas Lane, president and CEO of Genesis Bioventures, said, "This patent grant further validates the global patentability of the Mammastatin technology and extends our proprietary MSA test to 16 European nations. The issuance of this patent will be very important as we gain further regulatory approval and market presence for the Mammastatin technology internationally."

The MSA was initially developed at the University of Michigan Cancer Center and is licensed exclusively to Genesis Bioventures for scientific and commercial development as a blood test to assess women's health. The company also has the exclusive worldwide option to develop Mammastatin for breast cancer therapeutic purposes.