• AMDL (Tustin, California) reported that it has completed its pre-investigational device exemption (IDE) for the use of its DR-70 test kit in monitoring colon cancer patients. AMDL with operations in Shenzhen, Jaingxi and Jilin, China, through its wholly owned subsidiary, Jade Pharmaceutical (Hong Kong), is an international biopharma company. AMDL together with Jade engages in the development, manufacture and marketing of proprietary pharmaceutical and testing products.

• Cytyc (Marlborough, Massachusetts), a provider of surgical and diagnostic products targeting cancer diagnostics and women's health, reported that 12 studies presenting data on the MammoSite Radiation Therapy System (RTS) were featured at the 48th annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO; Fairfax, Virginia) in Philadelphia last week. The studies evaluated a range of parameters including insertion techniques, treatment efficacy, toxicity rates, and cosmetic results. The studies presented included single institutional experiences as well as multi-site evaluations.

• diaDexus (South San Francisco) reported results of a study demonstrating that Lp-PLA₂ (lipoprotein-associated phospholipase A₂) independently predicts both the severity of obstructive coronary artery disease (CAD) at the time of coronary angiography and future cardiovascular problems, including death, the company said. The results were published in the November 2006 issue of the American Heart Journal. Lp-PLA₂, a cardiovascular-specific inflammatory biomarker, was measured using the PLAC test, developed by diaDexus. The predictive ability of Lp-PLA₂ was independent of traditional risk factors, C-reactive protein (CRP, a systemic inflammatory biomarker), and statin and antihypertensive medication use. "These data further cement the relationship between lipids and inflammation," said John Carlquist, PhD, of the Cardiovascular Department, LDS Hospital, University of Utah (Salt Lake City), and a study investigator.

• Eastman Kodak (Rochester, New York) said it has submitted the final module of a pre-market approval submission (PMA) to the FDA for approval of its computed radiography (CR) system for mammography. The final module contains data and test results from the clinical trials Kodak has concluded at several sites in the U.S. and Canada. The FDA has already accepted and closed review of the previously submitted modules covering manufacturing information and non-clinical data. The FDA filing is on track with Kodak's plan for obtaining regulatory approval in the U.S., so that when approved, the company may begin selling its Kodak Directview CR Mammography Feature in the U.S. next year. Kodak's CR mammography feature will offer the ability to produce high-resolution scans for mammography applications (50 microns per pixel — or 20 pixels per millimeter) when using Kodak Directview CR Mammography Cassettes and EHR-M screens.

• Heartscape Technologies (Columbia, Maryland) reported enrollment of the first patient in the OCCULT-MI trial. The Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT-MI) trial will measure the impact of a more complete view of the electrical signals of the heart with the PRIME ECG System, compared with the standard ECG, including time to treatment (cardiac catheterization sheath placement) for patients diagnosed using PRIME versus the time to treatment using the standard 12-lead electrocardiogram. The first patient was enrolled in the trial by clinicians at Baystate Medical Center (Springfield, Massachusetts). Designed primarily for emergency department use, PRIME is a new diagnostic system that uses 11 easily-applied, self-adhesive plastic strips containing 80 data collection points, or leads, to cover the front and back of the body. The 11 strips allow analysis of the heart's electrical activity with 360 degrees of spatial resolution, which has the potential to detect critical diagnostic information not visible with a traditional electrocardiogram, the company said.