A Diagnostics & Imaging Week
Abbott Laboratories (Abbott Park, Illinois) and Celera Diagnostics (Alameda, California) reported that Abbott Molecular has received CE mark certification for a real-time polymerase chain reaction (PCR) test for monitoring hepatitis C (HCV) viral load in patients.
Celera Diagnostics is a joint venture between the Ap-plied Biosystems Group (Foster City, California) and Celera Genomics Group (Rockville, Maryland) of Applera (Norwalk, Connecticut).
The Abbott RealTime HCV assay has been developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology provided by Applied Biosystems.
The approval allows the test to be marketed in the member countries of the European Union. The test is not approved for use in the U.S.
Abbott noted in a statement that quantitative measurements of HCV levels in plasma or serum "have been shown to be an essential parameter in the prognosis and management of HCV-infected individuals." They said an initial measurement of HCV viral load can guide a decision to begin antiviral therapy, while monitoring HCV RNA levels during therapy can influence its duration.
"One of the key impediments of molecular testing we've addressed with the Abbott m2000 system is the complex and heavily manual procedures required, from the preparation of patient samples to the analysis of data," said Edward Michael, president, Abbott Molecular. "By taking automation to another level, we're helping molecular laboratories deliver patients' test results faster, easier and more accurately."
The Abbott m2000 system purifies the nucleic acid (RNA) from the specimen and automatically combines this with the assay reagents. The system's software is designed to be user-friendly; data are automatically calculated to provide reliable patient results for HCV viral load testing. In real-time PCR, the amplified DNA sequences are detected throughout the PCR process, instead of at the end of the amplification process.
Abbott said the instrument and reagents "allow laboratories to provide highly accurate test results more quickly, increase productivity and help reduce human error, resulting in consistent and reproducible results."
Carsten Tiemann, PhD, director of molecular diagnostics at Laboratory Dr. Krone & Partner in Germany, said, "Given the reproducibility and precision of this test to quantitate HCV RNA levels across a broad dynamic range, physicians can be confident about assessing viral levels in their patients and determining the most appropriate course of therapy."
In June, Abbott and Celera Diagnostics reported receiving CE mark certification of the Abbott RealTime HIV-1 assay for the Abbott m2000 system. Additional tests are in development for the system, including methods for detecting hepatitis B, chlamydia and gonorrhea.
"The CE certification of both our HIV-1 and HCV real-time assays represents an important step in our commitment to enhancing molecular testing through a growing portfolio of automated assays," said Kathy Ordonez, president of Celera Diagnostics. "Our exclusive partnership with Abbott in molecular diagnostics continues to deliver products that improve the capacity and sensitivity in clinical testing."
In 2002, Abbott and Celera Diagnostics entered into a long-term strategic alliance to develop a broad range of in vitro molecular diagnostic products for disease detection, disease progression monitoring and therapy selection.
SurePath use growing in UK
TriPath Imaging (Burlington, North Carolina) said its UK distributor, Medical Solutions plc, has been awarded an exclusive five-year contract to supply the SurePath liquid-based Pap test to the Greater Lincolnshire Primary Care Trusts, Path Links Cytology Service and the Northern Lincolnshire and Goole NHS Trust.
Paul Sohmer, MD, chairman, president and CEO of TriPath Imaging, said, "With this contract, we now have cumulative commitments that represent nearly 27% of the market in the UK, 29% in England and Wales. We expect to continue to grow our opportunity in the UK as other regions finalize their decisions."
TriPath manufactures solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. TriPath Oncology, a wholly owned subsidiary of TriPath Imaging, develops molecular diagnostic products for malignant melanoma and cancers of the cervix, breast, ovary and prostate.
MSI eyes growth in Ukraine, China
Another company seeing growth opportunities for its rapid test kits is Medical Services International (MSI; Edmonton, Alberta), which said it has received regulatory approval of its VScan Hepatitis C, Tuberculosis and Syphilis rapid test kits in the Ukraine. The company had previously announced approval of its HIV test kit in that country.
MSI said, "There is a serious tuberculosis problem in this part of the world and the fact that there is a rapid test kit for TB that is as accurate as the VScan TB test kit and gives no false positives will be extremely helpful to medical personnel in treating this disease."
The company said it is in the process of registering all four test kits in other countries in the region and is working with its distributor for the area to develop a comprehensive marketing program.
MSI also said that it has received a letter of commitment from the Shanghai Police Department that it would begin using the company's VScan HIV test kit. The test kits will be deployed as part of regular equipment for use in the field as well as in their rehabilitation centers.
The company said that in a recently published article, it was indicated by the National Institute of Infectious Diseases that HIV/AIDS appears to be spreading along drug trafficking routes extending from Yunnan Province to Southeast Asia. Researchers have discovered two strains of HIV and have said they believe the strains found in China have traveled from Laos, Myanmar, Thailand and India.
MSI said the VScan HIV rapid test kit is one of the few kits that detects both strains.
Sudan buys four Statscan systems
Lodox Systems North America (South Lyon, Mich-igan), maker of the Statscan Critical Imaging System, said it has signed a $1.2 million contract with the Sudan Freezone Company, a Sudanese government agency. Two Statscans already have been delivered to state hospitals in Khartoun and two other systems are expected to be delivered and installed in 1Q06.
The Statscan is a flexible-format digital radiography system used for quick diagnoses in hospital trauma units and emergency departments. Its low-dose digital X-ray technology is capable of quickly providing high-resolution, full-body X-rays.
Rodney Sandwith, Lodox product manager, noted that many African countries barely have the resources for medical technology that can only perform single, highly specialized tasks. The Statscan system provides value because it has multiple uses.
"Statscan is a digital radiography system ideal for trauma, military and pediatric medicine as well as general radiography," Sandwith said. "Its images can show soft tissue as well as bone simultaneously, which also makes it superb for screening for diseases such as tuberculosis, one of Africa's most prolific and destructive diseases."
Parsec documentation completed
IVAX Diagnostics (Miami) said that all documentation required by the European Community Directive 98/79/CE on in vitro diagnostic medical devices has been completed by its Delta Biologicals (Pomezia, Italy) subsidiary for the production of the Parsec System instrument.
By completing this process, IVAX Diagnostics said it is permitted to make declarations of CE conformity when the Parsec System instrument is marketed in countries where CE mark certification is sufficient for the release of in vitro diagnostic medical devices.
IVAX Diagnostics, 74% owned by IVAX Corp., said it anticipates U.S. commercial launch of the Parsec system later this year.