A Diagnostics & Imaging Week

OraSure Technologies (Bethlehem, Pennsylvania) said it has reached an agreement on the principal terms to settle its pending patent infringement lawsuit against Schering-Plough Healthcare Products (Kenilworth, New Jersey).

Schering-Plough will receive a license to OraSure's patents in the U.S. over-the-counter market and OraSure will receive payments of past and future royalties.

OraSure filed the lawsuit in 2004 alleging that Schering-Plough's manufacture and sale of its Dr. Scholls Freeze Away cryosurgical wart removal product in the U.S. OTC market infringed several OraSure patents.

In January the companies reported collaboration for the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus using OraSure's OraQuick technology platform.

OraSure makes oral fluid specimen collection devices using oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.

In other patent news:

  • Xenomics (New York), a developer of next-generation medical DNA diagnostic technologies, reported issuance of a U.S. patent, "Methods for detection of nucleic acid sequences in urine," that covers use of its transrenal nucleic acid technology in the area of infectious disease diagnostics and monitoring.
    Transrenal nucleic acids (Tr-DNA and Tr-RNA) are fragments of DNA and RNA from cells dying throughout the body that cross the kidney barrier from blood to urine and can be used for genetic analysis, the company noted. Xenomics' previous patents covered applications of the Tr-NA technology for prenatal genetic testing, tumor diagnostics and monitoring, and detection of rejection episodes after organ transplantation. The new patent covers diagnosis and monitoring of infectious diseases, the most rapidly growing area of molecular diagnostics, the company said.
    The molecular diagnostic segments are projected to outperform the overall diagnostics market, growing from $13.8 billion in 2005 to $22.7 billion in 2010, according to Xenomics. Currently, the largest market application segment for molecular diagnostics is infectious disease testing, the company said.
  • Nanogen (San Diego) reported receiving U.S. Patent No. RE39,816, a reissue of U.S. Patent No. 6,461,828, titled, "Conjunctive Analysis of Biological Marker Expression For Predicting Cardiac Mortality."
    The patent relates to the combined use of a cardiac marker of cell injury, such as Troponin I, with a marker of organ adaptation, such as brain natriuretic peptide (BNP), for prognosis of chronic congestive heart failure (CHF) patients. Nanogen said the claims strengthen its intellectual property rights around the combined use of these two types of biomarkers.
    "The combined use of Troponin I and BNP to evaluate the progress of congestive heart failure is just one example of how physicians currently combine biomarkers in cardiac care," said Nanogen CEO Howard Birndorf. "Reaffirmation of our IP position strengthens our cardiac-related patent portfolio and positions us to market leadership in point-of-care products that meet current clinical needs."
    The company has products in the market that test for cardiac markers separately. The company offers the Cardiac STATus Troponin I rapid test product line acquired in 2006 and earlier this year announced the commercial release of its StatusFirst CHF rapid test which uses the NT-proBNP marker. In addition, Nanogen holds IP rights around the use of multiple markers in a combined diagnostic test device with its 3-in-1 patent.
    Nanogen's products include real-time PCR reagents and kits based on its probe technology branded as MGB Alert and Q-PCR Alert, and a line of rapid point-of-care diagnostic tests used in urgent care settings to aid in the diagnosis of heart failure conditions.