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Dx Focus: Trovagene, Strand HPV MOU; Med Fusion, Roche Alliance; IMDx Gets Canadian Dx Licensure


Trovagene said this week that it has entered into a memorandum of understanding with Strand Life Sciences to offer Trovagene's urine-based human papillomavirus screening test in India and South Asia.

Under the terms of the agreement, Bangalore-based Strand will license and validate Trovagene's HPV urine test and high-risk HPV DNA assays for clinical diagnostic and carrier screening use in India and countries in the South Asian Association for Regional Cooperation.

Strand intends to establish Trovagene's HPV assay technology in its molecular diagnostic laboratory operations and to perform extended analytical and clinical validation studies in its target markets. The initial validation will assess the diagnostic accuracy using urine as a specimen for HPV testing in various stages of disease progression, ranging from low-grade erosions to established cervical cancer.

Strand will then compare the test to standard cytology and Pap staining as well as a commercially available standard molecular test for detecting HPV DNA from cervical smears.

The companies said that Strand also intends to explore and validate the clinical utility of HPV DNA testing as a risk indicator and pathological cause of oral cancer in buccal swabs, biopsies, and saliva/sputum specimens.

"The potential to use urine, an easily obtained and stable testing sample, for high-risk HPV carrier screening across medically underserved areas is very promising," Vijay Chandru, chairman and CEO of Strand, said in a statement. "We are pleased to be working with Trovagene, a leader in this field, on this important project that has the potential to make HPV screening broadly available in the region and to become a new standard of care."

Roche said this week that it has established a strategic alliance with Lewisville, Texas-based Med Fusion that establishes the company as a Roche Molecular Center of Excellence for the next five years.

As a Roche MCOE, Med Fusion's molecular diagnostics laboratory will offer physicians and patients molecular technologies such as Roche's Cobas 4800 BRAF V600 Mutation Test, a companion diagnostic approved by the US Food and Drug Administration in 2011 to identify patients who are eligible for treatment with the drug Zelboraf for inoperable or metastatic melanoma.

Established in 2002, Roche's MCOE program is designed to create a network that enables non-competing regional laboratories across the US to collaborate and capitalize on scientific knowledge in molecular testing and help accelerate the advancement of new test methods and technology, Roche said.

Med Fusion, an integrated laboratory and clinical trials service organization that supports healthcare providers and biotech and pharmaceutical companies, is one of 35 labs in the US and three in Texas that have joined the Roche MCOE program.

IntelligentMDx said this week that it has received ISO certification to design, develop, and manufacture in vitro diagnostic devices for infectious disease testing in Canada.

IMDx, based in Cambridge, Mass., said that it underwent an audit for conformation to ISO 13485:2003 and implementation of requirements from the Canadian Medical Devices Regulations. The company will now obtain licenses to commercialize its tests in Canada.

IMDx's infectious disease diagnostic portfolio includes CE-marked tests for toxigenic Clostridium difficile, vancomycin-resistant Enterocci, and Group B Streptococcus. The company is also developing tests for herpes simplex virus I and II, influenza A/B, respiratory syncytial virus, Epstein-Barr virus, and BK virus, among others.