A Diagnostics & Imaging Week

Diagnostics firm BMD (Biomedical Diagnostics; Marne-la-Vall e, France) reported raising EUR 5 million ($6.25 million) in a new funding round — its third — following rounds of EUR 4.6 million ($5.75 million) in 2000 and EUR 9.3 million ($11.6 million) in 2003.

BMD said that this latest round will enable it to further develop its Fidis-Caris products and technology, as well as boost international sales, particularly in the U.S.

BMD recently obtained a first FDA approval for its Fidis diagnostics products. Fidis (for Fast and Innovative Diagnostic Instrument Solution), the firm's flagship technology, combines the measurement platform of BMD's U.S. licensing partner Luminex (Austin, Texas) and its own immunoanalysis technology.

BMD bills this combination as a "multiplex" system that enables multiple, high-throughput autoimmune diagnostics to be carried out simultaneously and on a single patient blood sample, and calling it "a breakthrough in autoimmune diagnostics, compared to the labor-intensive methods involving separate and successive tests and samples."

The Caris (for Carrier for Assay Reagents and Immuno Samples) platform is a biological automated sample preparation module for use with Fidis or other diagnostics systems. The current version of Fidis diagnostic kits focuses on autoimmune pathologies, and BMD said it will soon be available for infectious and genetic diseases.

Truffle Venture and CDC Enterprises Innovation led the round, followed by AGF Private Equity, Siparex, Auriga Partners, Ventech and 123 Multinova.

The investors said that the key factor in supporting the financing was the "disruptive" technology used in Fidis. BMD says that it holds a key position "in international markets, particularly through Fidis," and that it is pursuing a strategy of developing niche markets "where the major players in this sector are absent."

"This new investment is a strong vote of confidence in BMD from our investors and will allow us to consolidate our international position in this extremely competitive part of the market," said Dr. Patrick Poty, CEO of BMD. "This is particularly true of the U.S., where we are competing with the market leaders and where this new funding will allow us to gain market share."

Founded in 1986, BMD offers solutions in the fields of autoimmune diseases, infectious diseases and allergies. The company also offers immunochemical tests for diagnosing heart failure and other coronary problems. BMD reported 2004 sales of EUR 20 million.

German lab joins diagnostics working group

Bioscientia (Ingelheim, Germany), an international reference laboratory, said it will participate as a European site for a joint working group on molecular diagnostics initiated by Sequenom (San Diego) and Siemens Medical Solutions (Malvern, Pennsylvania).

Sequenom's MassArray Compact System, a genetics analysis platform, will be installed at Bioscientia's clinical reference laboratory facility in Germany to benchmark the MassArray System in a molecular diagnostic testing environment.

Siemens Medical Solutions, a leader in medical instrumentation and medical information technology, will contribute project funding and engineering expertise and Bioscientia, a molecular genetic analysis provider, will perform the study. Sequenom will provide its MassArray Compact, consumables, technical support and analytically validated assays for specific tests, including deep vein thrombosis and HIV.

Siemens and Sequenom formed a partnership late last year to work in concert with participating reference laboratories to execute a comprehensive functional requirement analysis for a molecular diagnostics platform. Bioscientia joins Specialty Laboratories (Santa Monica, California) as a part of the joint working group.

The first phase of the joint program is a benchmarking study evaluating the analytical data quality and current workflow of the MassArray System in clinical reference laboratories. Sequenom said it expects the benchmarking study to be completed by 4Q05.

"One of the goals of the joint working group is to evaluate the utility of mass spectrometry through benchmarking studies," said Mohammad Naraghi, MD, PhD, senior vice president of business development at Siemens. "Bioscientia has a state-of-the-art molecular genetics analysis laboratory and brings more than 25 years of clinical diagnostic experience to the team. Their global client base and breadth of their experience will be a major asset."

Finnish university to get FLEX system

The University of Kuopio (Kuopio, Finland) said that it has ordered a FLEX Pre-Clinical Imaging System from Gamma Medica (Northridge, California), with the system to be delivered this summer.

The dual modality FLEX SPECT/CT system will be housed in the university's Department of Biomedical Nuclear Magnetic Resonance, part of the A.I. Virtanen Institute for Molecular Sciences, one of six biocenters in Finland.

Juhana Hakumaki, MD, PhD, head of the Department of Biomedical NMR, said that projects targeted for the FLEX system include "imaging of tumor-targeted and CNS-targeted peptides and gene therapy in vivo. The FLEX system with its SPECT and CT modalities will perfectly complement our existing preclinical MRI systems, creating the first multimodal preclinical imaging facility in Scandinavia."

David Wilk, Gamma Medica's senior vice president of sales, termed the University of Kuopio "one of the leading research institutions in molecular medicine and gene therapy in Europe. We're pleased to bring Dr. Hakumaki and his colleagues an imaging system that will help keep the University and the A.I. Virtanen Institute for Molecular Sciences at the forefront of medical research."

Gamma Medica manufactures imaging systems for both clinical and preclinical applications. For preclinical imaging Gamma created MicroSPECT, calling its X-SPECT system "the market leader in the preclinical SPECT category." It bills its X-PET system as having "the highest sensitivity and largest axial field of view among preclinical PET systems." Its X-O system is a standalone Micro CT device that can perform full body scans on a wide range of subjects in less than one minute, making it one of the fastest in the industry.