A Diagnostics & Imaging Week

Siemens Healthcare (Hoffman Estates, Illinois) reported the establishment of its first molecular imaging biomarker production facility in Chennai, India. The company said the new facility will enable healthcare providers in and around Chennai to access the positron emission tomography-computed tomography (PET-CT) technology to diagnose patients with life-threatening diseases, such as cancer and cardiac and neurological ailments.

PETNET Solutions, a subsidiary of Siemens Medical Solutions USA, operates the largest PET radiopharmacy network, with 49 radiopharmacies and distribution centers in the U.S., South Korea and the UK that produce and distribute PET radiopharmaceuticals to hospitals, clinics and research facilities for PET imaging.

The new facility in Chennai "will produce and supply the required radiopharmaceuticals to hospitals that have positron emission tomography-computed tomography facilities, which will help ease the burden of healthcare providers to produce their own radiopharmaceuticals," Siemens said.

The Indian facility will feature a Siemens Eclipse HP cyclotron and will be Siemens' first molecular imaging biomarker production facility in India.

LabCorp licenses MGMT testing tech

OncoMethylome Sciences (Liege, Belgium) and Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said that the Belgian company has granted LabCorp an exclusive license on certain IP technology to perform commercial MGMT methylation laboratory testing services in the U.S. and Canada, subject to limited exceptions.

LabCorp's Esoterix Clinical Trials Services Division also was selected by OncoMethylome as one of its preferred sub-contractors of MGMT methylation testing services for clinical trials.

OncoMethylome will receive an up-front fee, milestone payments and royalties from LabCorp. Other terms were not disclosed.

The companies said MGMT methylation has been shown to be a common event in many cancers and predictive of response to some cancer therapies. For example, they said, "MGMT methylation status has been shown to be a promising potential predictor of response to alkylating agent-based chemotherapies used to treat patients with malignant brain tumors, and therefore is of interest to oncologists who treat such patients."

LabCorp said it plans to determine MGMT methylation status using methylation-specific polymerase chain reaction (PCR) technology licensed from OncoMethylome Sciences.

Because of the potential for broader applications of the oncology marker, the evaluation of MGMT methylation is being integrated into numerous international clinical trials for patients with brain cancer and other cancers.

"This test is aligned with our focus on companion diagnostics and we are excited by the potential of the MGMT methylation test to help oncologists provide better patient care and guide therapy decisions," said Dr. Myla-Lai-Goldman, executive VP, medical director and chief scientific officer for LabCorp.

Biovator developing allergenicity test

In less than a year, animal allergenicity testing for the production of cosmetics in the European Union will be banned, leaving only a limited time to find alternative methods to avoid further exemptions. Biovator (Stockholm, Sweden) said it is developing a solution to part of the problem with its test tube-based technology the in vitro CPA test.

Government investment agency ALMI Företagspartner, in conjunction with Biovator owner LinkMed, has decided to provide funding to further develop the procedure, which uses human tissue to identify substances that cause allergic reactions.

Biovator said the technology, which could replace some of the animal testing currently done in the development of medicines, cosmetics, foods and in the chemical industry, will enable the identification of allergens.

Currently, animal testing is used to trace allergens.

Other investors include IBL Hamburg, a German immunobiological diagnostics company; Medicago, a Swedish biochemical firm, Linköping University and AstraZeneca.

Biovator said development work on the test is proceeding on schedule, and with the help of an industry partner, it plans to have the method ready for commercial use in the first half of 2009.

The company's test is based on work carried out by Professor Birger Andersson in the early 1990s at Stockholm's Karolinska Institute. Andersson was one of the first in the field and his method for in vitro testing became known as the Cytokine Profile Assay (CPA).

"Our test will be more reliable than current methods because tests on animals can only be used to identify Type 4 allergies skin conditions. At present, there is no test for Type 1 allergic reactions airborne allergies an area where there is a proven medical need," said Biovator CEO Stan Mikulowski.

In vitro testing also is quicker and less expensive than animal testing.