A Diagnostics & Imaging Week Staff Report

CBI Services (Richmond, Virginia), a business unit within the Commonwealth Biotechnologies group of companies, has been notified that its patent “Detection and Quantification of Human Herpes Viruses” was issued by the U.S. Patent and Trademark Office on March 4 as U.S. Patent 7,338,761.

Robert Harris, CBI president, and Executive VP Thomas Reynolds are co-inventors of the patent which has been assigned to Vigen Laboratories (Wilmette, Illinois). Development work leading to the patent was done at CBI under contract to Vigen.

Under an exclusive royalty-bearing license agreement with Vigen, CBI has been performing the assays detailed in the patent for the past seven years for physicians and clinics across the country. Now that it is patent protected, the technology will be offered to third-party licensees. CBI and Vigen will share equally in any licensing and royalty stream from a third party licensee.

There are eight known human herpes viruses (HHVs). The alpha herpes viruses include the simplex viruses, HSV 1 and HSV 2, and varicellovirus, HHV 3. The beta herpes viruses include cytomegalovirus (HHV 5), HHV 6, and HHV 7 (Roseolovirus). The gamma herpes viruses include HHV 4 (Epstein Barr virus) and HHV 8 (Rhadinovirus).

It is estimated that more than 90% of the world’s population is infected with EBV, which is associated with infectious mononucleosis (glandular fever).

CBI’s assay platform provides rapid and specific assay of each of the various HHVs down to as few as 10 copies of viral DNA in patient samples. The assay has been successfully applied to peripheral blood serum, sputum, cerebrospinal fluid, and various laboratory preparations. The CBI assay platform for the different HHVs offers a significant advance for detecting, identifying, and monitoring the course of infection.

“This assay platform was developed at CBI to meet the research needs of our customer, Vigen Laboratories,” said Harris. “We rapidly moved the assay platform from the lab bench and offered this service to clinicians who use the assay to help assess ongoing treatment of their patients. With our intellectual property now protected, we will look to out-license this technology to a clinical laboratory service provider who can commercialize the assay on a large scale.”

In other patent news: Jivan Biologics (Berkeley, California) has been awarded U.S. Patent #7,340,349, “Method and System for Identifying Splice Variants of a Gene.” The issued claims cover mathematical algorithms for determining the expression levels of splice isoforms of a gene in a sample using microarrays with exon junction probes.

“The ‘349 Patent validates JIVAN’s position as a leader in the growing market for DNA microarrays to detect alternative splicing,” said Subha Srinivasan, PhD, CEO of Jivan. “Powerful data analysis is critical to the adoption of splicing arrays, the next generation of expression arrays.”

The company said the ‘349 Patent fits in with its broader strategy of providing a complete solution for splice isoform expression, ranging from array design to microarray services to data analysis to PCR validation.

Privately held Jivan said it provides a full catalogue of splice variant microarrays, analysis software and PCR primer designs to benefit all stages of the drug development pipeline: biomarkers in blood, diagnostics, target validation, toxicology and basic research.