Diagnostics & Imaging Week
and D&IWs

Flush with funding and protected by a portfolio of patents for a novel technology that promises to break open a market for point-of-care (POC) diagnostics estimated at $11 billion, Ian Campbell is confident about the future of Molecular Vision (London).

After seven years developing a lab-on-chip platform that lends itself to a broad range of bedside diagnostics for cardiac, renal, diabetes and infectious diseases, the chief executive said the only blip on the radar is that he has just 18 months-worth of development time.

“In the short term, we have a unique platform,” he told Diagnostics & Imaging Week with his rolling Scottish brogue. “But the window of opportunity to prove the concept and get to market is less than two years. There are a number of diagnostic players moving on this.”

Since 2004 Molecular Vision, a spin off from the Imperial College incubator Imperial Innovations (also London), attracted investments totaling $4.6 million from the Geneva-based group Acrongenomics for developing a combination of microfluidics and light-responsive polymers on a disposable diagnostic device.

In May 2006, Acrongenomics signed a follow-on $6.5 million joint development agreement with Molecular Vision.

Acrongenomics formally acquired 10.9% of the shares in the company the first week in February and one week later announced a full acquisition of Molecular Vision will be completed before the end of 1Q08.

“Having seen all the applications open to the device it is now appropriate for us to protect our initial investment and take total control over the rapid commercialization of this exceptional and versatile technology,” said Dr. Dimitris Goundis, CEO of Acrongenomics.

Molecular Vision’s unique platform promises to break the barrier that has so far stymied widespread use of POC diagnostics at the bedside or hospitals or a general practitioner’s office: the imposing cost of the instrument needed to read the low-cost, disposable plastic test slides.

While the chemistry, biological processes and electronics for lab-on-chip applications have been miniaturized in recent years to the micron, and even nano-scale, the machines analyzing the results from the test are often as large and just as expensive as the instruments used in traditional pathology labs.

In March 2007 at Imperial College, Molecular Vision demonstrated its BioLED (light-emitting diode) technology using microfluidics channels to pass a sample through embedded emitters and photo detectors for optical characterization of known biomarkers for kidney and cardiac disease using fluorescence, absorption, and chemiluminesence.

Pearson Matthews (Kingston Upon Thames, UK) signed on in June 2007 to design a commercial prototype and Molecular Vision in August received 500,000 ($983,000) from Imperial Innovations.

One year later, Campbell told D&IW that Molecular Vision is ready to demonstrate a five-channel prototype of the device with two parallel urine-based assays for creatine and vitamin C to diagnose kidney function.

He said a third channel will be demonstrated in parallel later this year for microalbuminurea, a marker for diabetes patients who may have a failing kidney.

Clinical trials for the platform are scheduled for 3Q08/4Q08, he said, anticipating a milestone product approval before the end of 2009.

The end point for the clinical trial is demonstrating the analytical capabilities of a number of standard pieces of laboratory equipment can be duplicated in a simple to use compact hand held device.

The results of a comparative trial measuring creatinine in urine will put the software loaded on a personal digital assistant (PDA) against the results from Siemens DCA 2000 analyzer for diabetes management where a microalbuminuria cartridge provides results for both albumin and creatinine markers.

Campbell said Molecular Vision is targeting “a very wide range of diagnostic tests based on the same procedures used in the laboratory and making them available in a physician’s office.”

“There is the potential of completely revolutionizing the POC diagnostics market,” he said.

Goundis of Acrongenomics goes further with his predictions setting the market potential at $11 billion and saying “the true versatility of this device is such that the unit can be taken into the field, not only to support community based health initiatives, but also in homeland security and in the veterinary field for in situ testing of infectious disease.”

Campbell said product development has accelerated steeply since the 2007 demonstration with a 100-fold increase to detection sensitivity through a combination of optimized light sources, light detectors and filters, “all of which are assembled at low cost and ideal for the point-of-care diagnostic market.”

Power3 introduces breast cancer test

Saying that the test is better suited to the local culture than is mammography, Power3 Medical Products (The Woodlands, Texas) has introduced its BC-SeraPro blood test for breast cancer to a dozen Middle Eastern countries, including Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, United Arab Emirates and Yemen.

While millions of American women receive mammography screenings each year as a means of early detection of breast cancer, many women in the Middle East avoid the procedure, often because of strong underlying cultural bias.

“Fully 70% of worldwide breast cancer cases occur in developing countries,” said Dr. Essam Sheta, a researcher at Power3, a company focused on the development of diagnostic tests for the early detection of breast cancer and neurodegenerative diseases. “Lack of early detection and diagnosis is the basis for this high incidence rate.”

Sheta said that while doctors in the U.S. use mammography, ultrasound and MRI to diagnosis women with breast cancer, “these procedures are available, but scarce in developing countries.”

The most prevalent cancer among women, breast cancer affects about 1.2 million women worldwide.

Power3’s BC-SeraPro test analyzes biomarkers — specific proteins, in a woman’s blood serum — to detect breast cancer.

In addition to providing these Middle East with a diagnostic test it said is “more suitable for their culture,” Power3 said the test will be a supplement to traditional mammography and MRI.

The company said that over the past 10 years, half the number of American women who had annual mammograms received false positive results, “often leading to painful and unnecessary breast tissue biopsies.”

Power3 said a sensitive blood serum diagnostic test such as BC-SeraPro “can help curtail the anxiety generated from false positive results that lead to unnecessary breast biopsy.”

Breast cancer specialists envision the test as a supplement to be performed in conjunction with the mammography. If the mammogram is positive and the test indicates a positive result, then the patient will proceed to MRI or biopsy.

Cepheid’s Xpert FII/FV assay gets CE mark

Cepheid (Sunnyvale, California) and Instrumentation Laboratory (IL; Lexington, Massachusetts) reported the release of the Xpert HemosIL FII & FV assay as a European CE-mark product under the European Directive on In Vitro Diagnostic Medical Devices.

The assay, which delivers results in just over 30 minutes with a single GeneXpert cartridge, detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots.

Developed and manufactured by Cepheid, the test is expected to be available for sale beginning March 4 through IL, which is the exclusive worldwide distributor for the Xpert HemosIL FII & FV assay.

Xpert HemosIL FII & FV is the first test to be commercialized under the exclusive development and distribution agreement for hemostasis molecular diagnostic tests entered into by Instrumentation Laboratory and Cepheid in April 2007.

“Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping,” said Cepheid CEO John Bishop. “The Xpert HemosIL FII & FV assay will allow laboratories to perform the test as needed — and integrate the results with other tests — providing physicians a comprehensive thrombophilia profile of their patients.”

The companies said FII and FV are the most common hereditary risk factors for venous thrombosis and “are key in the determination of genetic predisposition to the condition and the need for prophylactic treatment in high risk patients.”

They said the investigation of genetic and acquired defects leading to thrombosis is performed with the aid of both classic coagulation assays and molecular tests, but in the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Now, they said, Cepheid’s GeneXpert System enables FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory without the need for batch processing.

First shipment for CytoCor to Spanish market

CytoCore (Chicago), which is focused on the early detection and treatment of reproductive-tract cancers, reported its first order and shipment of SoftPAP cervical cell collectors to Palex Medical (Sant Cugat del Vall s, Spain), the second company in Europe to launch the CytoCore product.

SoftPAP is designed to collect a full 360-degree specimen from both the cervical canal and the outer surface of the cervix simultaneously resulting in a more complete and comprehensive specimen for Pap testing. Clinical studies have shown that SoftPAP collects a better quality specimen while reducing adverse events, primarily bleeding and spotting, by 95%.

Palex Medical is a medical equipment/solutions distributor to the Spanish hospital market based in the Barcelona area and will be the second company in Europe to launch CytoCore’s SoftPAP cervical cell collector, a device designed to enhance patient comfort and safety while improving the quality of cervical cell specimens for Pap testing.