A Diagnostics & Imaging Week

Molecular diagnostics firm Xenomics (New York), a developer of next-generation medical DNA technologies, has filed a provisional patent in Italy for its technology enabling the detection of Transrenal-DNA of HIV and tuberculosis through the safe and non-invasive process of urine sampling.

"The filing of the provisional patent on our breakthrough detection of TB and HIV-DNA in the urine of AIDS patients marks a continued step in our strategy to aggressively expand the company's intellectual property portfolio and to protect that property with broad and well-enforced U.S. and international patents," said Dr. Randy White, CEO of Xenomics. "To manage this critical area, we recently established our Department of Licensing and Intellectual Property, and appointed veteran patent agent Dr. David Ladner to lead the department. Through filings such as this, Dr. Ladner is spearheading the expansion of our intellectual property portfolio."

The company said it believes the application of its patented technology platform may enable the creation of more accurate testing using urine specimens. The technology also provides the ability to simultaneously detect both HIV and tuberculosis, a common co-infection in AIDS patients, with a single urine sample, and has implications for the detection and treatment of residual HIV infections.

The discovery was made at the Company's joint venture with the National Institute for Infectious Diseases (Rome).

Because the technology was developed in Italy, international patent regulations require that the patent be initially filed in that country where the discovery was made. The initial filing will lead to the filing of the broader European patent, and then to the U.S. patent.

Xenomics is developing and commercializing proprietary gateway DNA testing technology that has the potential to significantly expand the field of molecular diagnostics, currently a $1.5 billion segment of the healthcare and biotechnology industry.

Lifeline gets Greek MataScope order

Lifeline Biotechnologies (Reno, Nevada) reported that an initial order of its early breast detection microendoscope system, the MastaScope, has been shipped to Greece.

This initial shipment is expected to lead to future sales in Greece, the company said.

There are now MastaScope systems used in Egypt, Croatia, China and Puerto Rico as well as the U.S., according to Lifeline.

The MastaScope is used in the early detection of cancer and other abnormalities of the breast. The MastaScope has completed development and has entered the marketplace in the U.S. and internationally. The First Warning System, for assisting in the early detection of breast cancer, and the OvaScope, for assisting in the early detection of ovarian cancer, are continuing to be developed by the company.

The company also said it continues to carry out R&D of its premiere technology, the First Warning System, an early warning breast cancer detection system.

Lifeline develops technologies focused on prevention, early detection and diagnosis of disease conditions.

Affymetrix, BioMerieux in GeneChip accord

Affymetrix (Santa Clara, California) and BioM rieux (Marcy l'Etoile, France) signed a new agreement granting the French company comprehensive, long-term access to the GeneChip technology of Affymetrix for the development and marketing of in vitro diagnostic tests for breast cancer, plus an option for extending the agreement to other cancers.

The deal gives BioM rieux nonexclusive rights to DNA chips patented by Affymetrix, and to Affymetrix's instrumentation systems. Financial terms were not disclosed.

Chemicon in Amplifluor licensing

Serologicals (Atlanta) reported that its wholly owned subsidiary, Chemicon International, and OctoMethylome Sciences (OMS; Liege, Belgium), entered an agreement in which OMS licensed Chemicon's patented fluorescent detection technology, Amplifluor, for the development of diagnostic assays detecting DNA methylation patterns.

The Amplifluor system can be used for a variety of nucleic acid-amplification techniques, and can be incorporated in drug discovery, with other applications in genomics, clinical diagnostics, forensics, biothreat and food testing. Financial terms were not disclosed.

Sigma-Aldrich completes Proligo buy

Sigma-Aldrich (St. Louis) completed its acquisition of the Proligo Group from Degussa (Dusseldorf, Germany). Terms of the purchase were not disclosed.

Proligo, a global supplier of key genomics research tools including custom DNA, custom RNA and phosphoramidite raw materials used for DNA and RNA synthesis, had 2004 sales of about $40 million. Nine months of Proligo's operating results will be added to Sigma-Aldrich's performance in 2005, increasing overall sales growth by about 2%.