Diagnostics & Imaging Week Contributing Writers
Agendia (Amsterdam, the Netherlands) has closed a third funding round to advance development and marketing of its microarray-based cancer diagnostics. Total investment was not disclosed, but company CEO Bernhard Sixt said it was more than $10 million.
The company had raised a smaller, second round in October, but has taken on more financing now to exploit progress in clinical validation of its lead product, MammaPrint, a prognostic tool that predicts on the basis of an expression profile comprising 70 genes whether a woman newly diagnosed with breast cancer is likely to experience a recurrence. It stratifies patients more accurately than current criteria and spares about 20% from undergoing unnecessary chemotherapy.
"MammaPrint is significantly out-performing the Saint Gallen criteria, as well as other standards," Sixt said. Agendia's founders performed much of the underlying scientific work at the Netherlands Cancer Institute (Amsterdam).
A preliminary validation of the test, performed at five European cancer centers by an independent research consortium, has been accepted for publication in the Journal of the National Cancer Institute, Sixt said. The positive data also will enable a wider study, involving 6,000 patients, to begin in multiple centers. Some 250 were picked, he said, from around 800 applicants.
"There was a huge interest internationally, but the centers had to pass significant quality hurdles," Sixt said. The study is being conducted by the TransBIG consortium, which is partially funded by the European Commission's Sixth Framework Program. The trial sponsor is the Euro-pean Organization for the Treatment and Research of Cancer (Brussels, Belgium).
The product already has achieved registration under the CE marking program, which governs the sale of medical devices in the European Union, although sales remain modest at present. Five cancer centers in the U.S. also have access to the technology under an FDA investigational device exemption, which permits its use in clinical trials. "We are now talking about how to commercialize this on a broader basis," Sixt said.
Agendia currently performs all of the procedures required by the test. Its facility, Sixt said, is one of the few laboratories with ISO 17025 quality accreditation. "We have this overkill of quality because we want to concentrate on talking about clinical utility rather than test quality issues," he said. Eventually, the company aims to capture the test in a kit that can be used in clinical settings.
The company also is commercializing a second product, CupPrint, which identifies the primary tumor in cancers of unknown primary (CUP) – between 2% and 7% of all cancer cases, Sixt said, depending on the sophistication of the pathology employed. CUP has a poor prognosis, but about 15% of patients can have improved survival if the primary tumor is recognized sufficiently quickly.
"The distal metastases react to the same treatment as the primary tumor," he said. It can identify 39 clinically defined tumor types at present, based on a read-out of 800 genes.
Agendia will launch three more products over the next six months, Sixt said, two of which will provide further diagnostic information in breast cancer. The third will address a different form of cancer.
New Asian offices opened by Battelle
Battelle (Columbus, Ohio), a provider of contract R&D, technology commercialization and laboratory management services, has taken another step toward broadening its presence in the international marketplace by opening offices in Japan and South Korea.
The company said that although it has relationships in both countries that date back decades, the new offices mark its first full-time presence in the region.
"Battelle has had tremendously valuable relationships in Japan and South Korea in the past, but these new offices enhance our capabilities to meet customer needs and to use science and technology to solve important problems in Asia," said Rich Adams, president and CEO of both Battelle-Japan (Tokyo) and Battelle-Korea (Seoul, South Korea).
The opening of the two new offices is part of a growing international presence for the company and is a likely precursor to further entries into the Asian marketplace, Adams said.
Battelle-Japan marks a new chapter in the 35-year relationship between Battelle and Mitsubishi Corp. Battelle owns 60% of the joint venture; Mitsubishi the other 40%. The office is located in Tokyo.
Battelle-Korea is a wholly owned subsidiary of Battelle.
"These offices give us access to growing markets that could represent up to half of R&D spending worldwide within 25 years," said Carl Kohrt, president and CEO of Battelle.
BioMag finalizes Thailand agreement
BioMag (Orangeville, California) said it has finalized an agreement with Bangkok RIA Group, a laboratory, manufacturer and distributor of diagnostic services in Thailand. The companies last week reported signing a memorandum of understanding relative to the distribution accord.
BRIA will be responsible to apply to the Health Ministry of Thailand to acquire approval to initiate clinical trials in Thailand. BioMag's HTS-MTP Diagnostic System, including the proprietary HIV and hepatitis B assays, are to be tested during these trials.
Upon completion BRIA will have the exclusive distribution rights for the products in Thailand.
Clayton Hardman, president and CEO of BioMag, said, "Ninlawan Petchardaburanin, PhD, president and founder of BRIA, said that Biomag's revolutionary technology could ‘put BRIA out of business.' Joining and leading the company into clinical trials and having the exclusive distribution rights in Thailand ensures that BRIA will remain on the leading edge of diagnostic testing, while expanding sales."
BRIA was founded in 1989 to provide medical laboratory diagnostics services to hospitals, clinics and other medical care units. It later decided to transform itself into a holding company with a group of subsidiaries and has expanded geographic locations through its franchises throughout Thailand.
BioMag, through its wholly owned subsidiary, Biospectrum Technologies, is focused on identifying market "inadequacies" and filling those needs with new technologies and highly specific and sensitive assays.
TomTec unveils new imaging software
TomTec Imaging Systems (Munich, Germany) reported the introduction of its 4D RV-Function software for right ventricular function analysis. The company said the software is easy to use and enables fast and reliable measurements of RV functional parameters basing on 3-D echocardiographic datasets. The technology uses three-dimensional ultrasound data sets to combine the ease and speed of echocardiography with the accuracy of MRI. The software calculates a three-dimensional right ventricular surface model automatically from the endocardial contours in the 3-D data set. It uses this model to measure right ventricular end diastolic volume, end systolic volume and ejection fraction.