A Diagnostics & Imaging Week

TomTec Imaging Systems (Munich, Germany), a provider of medical imaging software solutions, and Advanced Medical Imaging Development (AMID; Sulmona, Italy), which is focused on innovations in medical image quantification techniques, have signed a long-term agreement to expand their previous partnership.

The new agreement, signed in late September, covers all fields of medical imaging and will combine the innovation and business capabilities of both companies. TomTec will be the exclusive channel for all AMID medical imaging technology to clinical end-users as well as to all business partners.

"We are excited about the partnership" said Bernhard Mumm, president/CTO of TomTec. "Combining AMID's strength and TomTec's technology will lead into new, exciting 2-D and 3-D quantification tools in echo and MRI. We will offer our clinical customers and our OEM partner's new and better software solutions to enhance diagnostic confidence and to streamline patient workflow."

Dr. Giovanni Tonti, CEO at AMID, said, "The long-term partnership with TomTec was a logical step for us. We can now focus our core activities and ... skills on the development of innovative solutions. With TomTec we have now the perfect partner to bring our combined 'High-Tec' products to the market."

Leukemia panel is CE-marked

Asuragen (Austin, Texas) said that the Signature LTx v2.0 Leukemia Translocation Panel has been released as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

The CE-marked Signature LTx v2.0 is a qualitative in vitro diagnostic device for use in a clinical laboratory to identify specific fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias. Clinical validation studies showed 100% diagnostic accuracy in comparison to standard cytogenetic methods. This represents the world's first Luminex-based molecular oncology IVD product.

The assay is a multiplex reverse transcription PCR (RT-PCR) amplification, followed by multiplex amplicon detection on the Luminex 100 IS or 200 system.

"Standard cytogenetic analysis by karyotyping or fluorescence in situ hybridization can be laborious or require multiple successive hybridizations to detect a given chromosomal translocation. [Our] expertise in multiplex RNA-based assays enables the rapid molecular diagnosis of leukemia fusion transcripts and therefore improves workflow and efficiency in the clinical laboratory while nicely complementing standard diagnostic hematopathology testing," said Asuragen President Rollie Carlson, PhD.

Quest's India unit gets accreditation

Quest Diagnostics (Madison, New Jersey) said its wholly-owned subsidiary, Quest Diagnostics India (Gurgaon, India), has received certificates of accreditation from the College of American Pathologists (CAP), a leading international laboratory accrediting organization, and the National Accreditation Board for Testing and Calibration Laboratories (NABL), the sole government-authorized laboratory accreditation body in India, for its diagnostic and clinical trials laboratory in Gurgaon.

In addition, the National Glycohemoglobin Standardization Program has awarded Level I Laboratory Certification to the laboratory. Level I Laboratory Certification, which is recommended by NGSP for laboratories conducting diabetes-related clinical trials, indicates that a facility's testing fulfills rigorous standards for delivering accurate hemoglobin A1c (HbA1c) testing for diabetes.

The Quest Diagnostics lab is one of only five laboratories in India to be certified by the program. The company said the prevalence of Type 2 diabetes in India is expected to grow more rapidly than in any developed or developing nation, growing from 28 million patients in 2007 to more than 60 million by 2017.

Distribution agreement for Luminex

Luminex (Austin, Texas) and Mingyuan Medicare Development (Hong Kong), a supplier of biomedical products in China, reported the signing of a distribution and supply agreement under which Mingyuan will serve as the exclusive distributor in China and Hong Kong of a series of newborn screening products being developed for the diagnosis of genetic disorders.

"Accurate and efficient newborn screening is essential to good pediatric care," said Chien Hoe Yong Henry, CEO/executive director of Mingyuan. "With Luminex's xMAP Technology, we can quickly and precisely screen infants for many genetic disorders at once. The technology and new tests being developed will help us advance the accuracy and speed of newborn screening across China and Hong Kong."

More than 20 million babies are born in China each year, and newborn screening of genetic disorders is mandated by the Chinese government.

The newborn screening tests to be distributed by Mingyuan will be developed by Luminex utilizing its xMAP Technology. Rather than detecting each genetic disorder one at a time, xMAP Technology can simultaneously analyze up to 100 unique assays within a single sample, making the large-scale screening more efficient, accurate and less costly.

1st patient treated using planning system

RaySearch Laboratories (Stockholm, Sweden) reported that the first patient has been treated at Uppsala University Hospital (Uppsala, Sweden) with a treatment plan prepared using a new treatment planning system supplied by the company.

An agreement was signed with the hospital in August for installation of the new system at the Svedberg Laboratory, which is integrated in the Oncentra MasterPlan treatment planning system from RaySearch's partner, Nucletron (Veenendaal, the Netherlands).

"The new treatment planning system saves substantial time with its user-friendly tools providing us with various optimization alternatives and the possibilities of making fine adjustments," said Christina Vallhagen Dahlgren, senior hospital physicist for proton therapy at University Hospital. "The dose calculations are exact and optimized to the clinical reality."

RaySearch was founded in 2000 as a spin-off from Karolinska Institute in Stockholm.

CE mark given Cobas hepatitis test

Roche Molecular Diagnostics (Pleasanton, California) reported receiving the CE mark for its Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0. The test offers the company's fully automated real-time polymerase chain reaction technology to achieve a broad dynamic range for the quantitative detection of hepatitis B virus (HBV) DNA in patient plasma and serum.

According to the World Health Organization (Geneva, Switzerland), some 2 billion people worldwide and about 350 million in Europe live with chronic HBV infection and are at risk of developing end stage liver disease and liver cancer.

"It is critical to monitor the levels of circulating hepatitis B virus as an indicator as to when hepatitis B therapies should be started, and to determine response to treatment," said Teresa Wright, MD, chief medical officer at Roche Molecular Diagnostics.