A Diagnostics & Imaging Week

Cepheid (Sunnyvale, California) reported the European release of the Smart CMV (cytomegalovirus) Assay for clinical diagnostic use on the SmartCycler System. The CMV assay was released under the European Directive on In Vitro Diagnostic Medical Devices.

Smart CMV is intended for rapid detection and quantitation of CMV viral load. CMV is a member of the herpes virus family, which includes the herpes simplex viruses and the viruses that cause chicken pox (varicella- zoster virus) and infectious mononucleosis (Epstein- Barr virus).

Most CMV infections are asymptomatic and often lead to undetected, latent infection and re-infection. Among immunocompromised patients such as organ transplant recipients, AIDS and cancer patients, CMV infection is a significant cause of disease and mortality.

Cepheid said periodic monitoring of CMV viral load in consecutive clinical samples is used to identify high-risk patients and to monitor their response to CMV therapy. "Because of their specificity and sensitivity, real-time polymerase chain reaction diagnostics like Smart CMV are an important tool in the effective clinical management of CMV patients," the company said.

"Cytomegalovirus is an important pathogen in immunosuppressed patients, including organ transplant recipients and AIDS patients. The clinical utility of quantitative CMV DNA tests in managing these patient groups has been well documented," said Mario Poljak, MD, PhD, head of the Laboratory for Molecular Microbiology and of the Slovenian AIDS Reference Center at the Medical Faculty of Ljubljana in Slovenia.

"Smart CMV is the sixth in a planned menu of CE IVD Mark products launching into the European market this year, and the third product in our expanding portfolio for use in the management of immunocompromised patients," said Cepheid CEO John Bishop. "[Our] scaleable SmartCycler and GeneXpert technologies are making it easier and cost effective for institutions of any size to reap the benefits of molecular diagnostics."

The SmartCycler System is a real-time PCR testing platform for hospitals, university research labs and government agencies. By automating the amplification and detection process, the system can deliver highly accurate and consistent test results from prepared biological samples in about 30 to 40 minutes, Cepheid said.

With up to 96 independently programmable reaction sites, the SmartCycler System can simultaneously run different tests with different protocols and at different times.

Blood sugar measurement breakthroughs

Two Israeli companies, OrSense (Nes Ziona) and Glucon (Petach Tikva), reported encouraging results of clinical trials at the American Diabetes Association's (ADA; Alexandria, Virginia) annual meeting in Washington last month.

No other companies had data from non-invasive blood sugar testing.

The OrSense device, the NBM-100G, uses a ring-like finger cuff that reads using occlusion spectroscopy, a method shown to generate continuous real-time optical signals across the finger, overcoming the key technological barrier to high sensivity needed to decipher the very low signal-to-noise ratio.

A study of 24 patients at the Sheba Hospital (Tel Hashomer) found that the optical readings were as sensitive and as accurate as needle pricks taken by Type 1 and Type 2 diabetic patients under home conditions.

Glucon's device for blood-sugar measurement reads blood glucose levels directly from a blood vessel, without puncturing the skin, using a novel photo-acoustic (optical and sound-based) technology, to give results that are as precise as invasive blood sugar measurement devices.

Both companies are preparing to mount FDA-guided clinical trials to prove that their devices are precise and sensitive enough to be approved as alternatives to glucometer readings, which need a drop of blood obtained by fingerstick.

'Next-generation' vision assessment

Nidek (Gamagori, Japan), a manufacturer of optical and eye care diagnostic instrumentation, reported the introduction of its OPD-Scan II ARK-10000, which it characterized as launching "the next generation in … quality of vision assessment."

The OPD-Scan II combines corneal topography, wavefront, autorefraction, keratometry and pupillometry into one system.

The system uses the principles of skiascopic phase difference to assess and determine refractive error map measurements. Nidek said the corneal topography function uses Placido disc technology to analyze thousands of data points to plot corneal contour, shape and refractive power.

The company said that by offering a variety of informative data maps, the OPD-Scan II provides detailed information on the total refractive error, wavefront, corneal shape, internal aberrations and overall visual quality of the eye, generating accurate and reliable information for optical diagnostics.

A new feature added to the OPD-Scan II ARK-10000 is the Corneal Navigator, which uses various corneal parameters from topography, to automatically determine corneal features and reveal possible corneal conditions on an instantaneous basis.

PreMD tops trial enrollment target

Predictive medicine company PreMD (Toronto) said that it has exceeded its enrollment target in the 600-subject PASA (Predictor of Advanced Subclinical Atherosclerosis) study with 650 patients. PASA is examining the relationship between skin tissue cholesterol (sterol) and carotid intima media thickness (CIMT), which refers to the thickness of the first two inner layers of the carotid artery wall. CIMT is an established predictor of heart attack and stroke.

The PASA study is aimed at supporting broader regulatory clearance for the PREVU(x) Point of Care Skin Sterol Test as well as PREVU(x) LT Skin Sterol Test as a tool to identify asymptomatic patients at risk of a primary event, such as heart attack or stroke.

Dr. Brent Norton, president and CEO, said, "We will be analyzing the data in the coming months and expect to be in a position to make various regulatory submissions to the FDA and in Canada and Europe before the end of the year."

PREVU(x) non-invasively measures the amount of cholesterol that has accumulated in the skin tissues, as opposed to blood. No fasting or other patient preparation is required for the test.

Clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels in the skin are correlated with higher incidence of coronary artery disease.

PREVU(x) POC is cleared for sale in Canada, the U.S. and Europe.

PreMD's cardiovascular products, which are branded as PREVU(x) Skin Sterol Test, are licensed worldwide to McNeil Consumer Healthcare. The company's cancer tests include ColorectAlert, LungAlert and a breast cancer test.

The company's research and product development facility is at McMaster University (Hamilton, Ontario).

CritiSense raises $1.2M

Israeli device start-up CritiSense has raised $1.2 million to take CritiView (CRV), its first generation product to clinical trials in 2007.

CRV is a patient monitoring system providing real-time continuous information via four physiological parameters, sensed at the tissue level that indicate a patient's systemic metabolic state, especially important in patients undergoing surgery or in intensive care units.

The round was led by U.S. venture capital firm Bridge Investment Fund (Cleveland), along with Clarion Group CEO Morton Cohen, Pontifax and Docor International.

CritiSense, founded in 2004 on the basis of intellectual property bought from Vital Medical, which closed operations, developed CRV by the company's co-founder and chief scientist, Avraham Mayevsky, former department head of life sciences and dean of the faculty of natural sciences at Bar Ilan University.

CRV uses an optical sensor for continuous, real-time multi-parametric physiological data at the tissue and cellular level, by monitoring mitochondrial function, microcirculatory blood flow and oxygen saturation, by way of tissue titration therapy.

Bridge Investment was founded to invest primarily in early stage Israeli medical device companies that are backed by venture capital, and are looking to establish a presence in Northeast Ohio. Symbionix is one of its portfolio companies.

It has $6 million for investment, but aims to raise another $15 million. It is managed in Ohio by former AOL business development manager Michael Goldberg, and in Israel by Avshalom Horan, former RadBiomed manager and Bank Leumi, chief technology investment officer; and Ariel Halperin, Tene Investments partner.

Horan said, "CritiSense didn't approach us because of our money. Rather, it was interested in taking advantage of Bridge's relationships with the Cleveland Clinic, University Hospitals of Cleveland and BioEnterprise Corp, a non-profit organization that assists Northern Ohio healthcare companies."

Nigerian order for HIV rapid tests

Chembio Diagnostics (Medford, New York) said it has received an order from the procurement agent on behalf of the U.S. Centers for Disease Control and Prevention office in Nigeria for 200,000 HIV 1/2 STAT-PAK rapid tests to be used for voluntary counseling and testing programs in that country.

The company said it plans to ship most of the order this quarter. The President's Emergency Plan for Aids Relief (PEPFAR) is funding the purchase. PEPFAR is a five-year, $15 billion global initiative to combat the HIV/AIDS epidemic.

The Nigerian Ministry of Health has designated Chembio's HIV 1/2 STAT-PAK as a screening test in four out of the eight testing protocols that comprise that country's Interim National Testing Algorithm. Nigeria is initially implementing a parallel testing algorithm, and as such uses two screening tests from different manufacturers on each patient tested.

Avi Pelossof, vice president of sales, marketing and business development at Chembio, said, "This is the first significant order from Nigeria since our tests were selected [there]. We believe Nigeria's demand for HIV rapid tests will increase significantly in order to meet treatment goals under PEPFAR."

About 3.6 million Nigerians are estimated to be HIV-infected. Only a small percentage of those estimated to be HIV-infected are aware of their status, and only 28,500 are currently receiving anti-retroviral treatment, according to a recent report to Congress by PEPFAR.