A Medical Device Daily

diaDexus (South San Francisco, California) reported that the U.S. Patent and Trademark Office (USPTO) has issued it a patent covering methods of diagnosing an individual’s susceptibility for developing atherosclerotic disease, including myocardial infarction and stroke, by analyzing a blood sample for lipoprotein-associated phospholipase A₂ (Lp-PLA₂) enzymatic activity.

Lp-PLA_2, an enzyme implicated in the formation of vulnerable, rupture-prone plaque, was discovered by scientists at GlaxoSmithKline (GSK; Research Triangle Park, North Carolina). This patent is one of a group of Lp-PLA₂-related GSK patents to which diaDexus has an exclusive commercial diagnostic license, the company said.

diaDexus sells the PLAC test, an Lp-PLA₂ immunoassay, for use as an aid in assessing risk of stroke or heart attack.

diaDexus is focused on the discovery, development, and commercialization of innovative, patent-protected diagnostic products with high clinical value. The PLAC test is a blood test that measures a new risk factor for heart disease and stroke—Lp-PLA₂, a cardiovascular-specific inflammatory marker implicated in the formation of vulnerable, rupture-prone plaque.

The PLAC test is cleared for marketing by the FDA as an aid in determining risk for coronary heart disease and ischemic stroke associated with atherosclerosis.

In addition to the PLAC test, diaDexus said it is developing a pipeline of new cancer diagnostic tests.

In other patent news: Caliper Life Sciences (Hopkinton, Massachusetts) said it has received a notice of allowance from the USPTO for a patent covering key methods of in vivo, non-invasive (in living animals, through opaque tissue) imaging of light generated from within mammals.

According to the company, Biophotonic imaging is rapidly expanding beyond current methods based on light sources genetically encoded in mammals to also include methods based on light sources that are conjugated (or combined) with a biocompatible entity and administered to mammals, the company said. Caliper’s newly allowed patent covers many of these developments in biophotonic imaging science, according to the company.

“In addition to providing researchers with the option to track disease states in an animal without requiring genetic modification of the animal to produce light, the methods covered by the new patent, which encompass a broad range of biophotonic imaging with conjugated probes, are particularly attractive for translation of pre-clinical applications and results into clinical settings,” said Kevin Hrusovsky, CEO of Caliper Life Sciences. “This patent furthers Caliper’s leadership position in the biophotonic imaging market. We intend to augment our considerable technology development efforts by also developing biomarkers and innovative conjugate imaging probes and applications for our customers using the technology covered by the patent.”

Caliper’s existing patent portfolio covers broad methods of in vivo imaging of genetically produced light generation. The new patent covers the use of conjugates comprising any biocompatible entity and a light source, either fluorescent or bioluminescent.

“[W]e believe this new patent will enable us to expand our existing licensing program to a larger group of companies, some of which are already performing noninvasive in vivo imaging with other manufacturers’ imaging equipment,” Hrusovsky said. “We believe revenues from additional imaging products and licenses will begin to materialize in the back end of this year and we are reaffirming our full year revenue guidance of $137 [million] — $143 million which reflects second half pro forma revenue growth of 14%-23% and GAAP revenue growth of 24%-34%.”

Caliper’s family of Xenogen IVIS imaging platforms provides scientists with biophotonic imaging technologies. Its IVIS systems are designed to deliver real-time in vivo imaging along with high sensitivity and exceptional data quality.