A Diagnostics & Imaging Week

Affymetrix (Santa Clara, California) reported that it has been selected by the SNP Health Association REsource (SHARE) project for a large-scale whole-genome association study. As part of the project, Affymetrix will collaborate with the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Biotechnology Information (NCBI) of the National Institutes of Health (all Bethesda, Maryland) to identify genetic variants associated with heart, lung, blood and sleep disorders.

The SHARE project will analyze more than 9,000 samples collected by the NHLBI and Boston University for the Framingham Heart Study. Clinicians have been using the Framingham Heart Study to measure data relating to cardiovascular disease since 1948, with data collected from more than 15,000 samples spanning three generations of individuals.

"The Framingham Heart Study is one of the most recognized clinical research projects in history and we are honored that the NHLBI has entrusted the genotyping of these valuable samples to Affymetrix," said Giulia Kennedy, PhD, senior director of genomics collaborations at Affymetrix. "Researchers have been waiting for decades for the right technology to come along and extract the genetic information contained in these samples. When this project is complete, researchers around the globe will have access to one of the richest medical datasets in existence."

The Affymetrix 500K Array is used to conduct these types of large-scale whole-genome association studies today. As part of the SHARE project, researchers will develop a data resource that will integrate genome-wide genotypic information with phenotypic information from multiple NHLBI studies. The data will be available to the scientific community for further genome-wide association analyses and will complement the data included in the recently announced Affymetrix Control Program.

Affymetrix began selling the first commercial microarray in 1994.

In other agreements news:

• Mayo Clinic (Rochester, Minnesota) and Biomoda (Albuquerque, New Mexico) have agreed to jointly conduct a validation study of Biomoda's technology, a noninvasive cytology-based lung cancer diagnostic.

Operating from its laboratory at Kirtland Air Force Base (Albuquerque), the company said it will announce additional strategic alliances over the next 90 days.

Mayo Validation Support Services, an affiliate of Mayo Clinic, assists pharmaceutical, biotechnology and diagnostic companies in the preclinical validation of promising targets, lead compounds, biomarkers and tests.

• Competitive Technologies (CTT; Fairfield, Connecticut) reported signing a worldwide service and representation agreement with Dr. Vincent Agnello of Lahey Clinic, a teaching hospital affiliated with Tufts University School of Medicine (Boston) to commercialize a laboratory test used to diagnose and monitor Systemic Lupus Erythematosus (SLE).

SLE, commonly called lupus, is an autoimmune disease characterized by the appearance in serum of antibodies directed against a number of "self" antigens. Lupus currently affects about 1.5 million people in the U.S.

Aris Despo, senior vice president, Life Sciences for Competitive Technologies, said, the Agnello technology "is a late-stage technology … ready for commercialization and provides a cost effective, scalable testing platform for the early detection of Lupus as well as the monitoring of therapeutic efficacy and flares."

The solid-phase assay is designed to significantly improve the detection of antibodies specifically directed towards dsDNA in serum with "unparalleled sensitivity and precision" compared to existing diagnostic methods that detect and have difficulty separating both ssDNA and dsDNA. The assay is adaptable to operate on commercially available chemiluminescence detection platforms and has clinical data with more than 10,000 assays performed at the Lahey Clinic, the company said.

Competitive Technologies is a technology transfer and licensing provider.