A Diagnostics & Imaging Week

Home Diagnostics (Fort Lauderdale, Florida) reported an agreement to be the exclusive supplier of a co-branded blood glucose monitoring system for Rite Aid (Harrisburg, Pennsylvania) drug stores. Home Diagnostics’ TRUEtrack will be available as the TRUEtrack for Rite Aid blood glucose monitoring system at 5,000 Rite Aid stores across the U.S. starting in March.

TRUEtrack uses biosensor and chip coding technology to generate accurate results in 10 seconds from a single microliter of blood. The TRUEtrack meter and test strips typically cost up to 30% less than other systems, the company said, and are covered by Medicare and most insurance plans.

In other agreement news:

• DexCom (San Diego) reported it has entered into a joint development agreement with Animas (West Chester, Pennsylvania) to integrate DexCom’s continuous glucose monitoring (CGM) technology into Animas insulin pumps.

The new product will be based on Animas’ advanced pump technology and DexCom’s Seven, a seven-day continuous glucose monitoring system. It will enable the Animas pump to receive glucose readings and display this information on the pump’s color screen.

Users will have access to real-time glucose readings and trending in addition to receiving alerts for low and high glucose readings. Having real-time readings displayed on the pump screen will not only allow users to make more timely adjustments to their insulin delivery – it will eliminate a separate receiver, reducing the amount of equipment required to use CGM and the pump system.

Under the terms of the agreement, Animas will contribute up to $750,000 to DexCom to offset certain development, clinical and regulatory expenses. The agreement is non-exclusive and does not impact either party’s existing third party development agreements.

DexCom anticipates the integrated system will be available to patients in 2009 or early 2010. Seven was approved by the FDA last June.

• Genomic Health (Redwood City, California) has partnered with Pfizer (New York) on the development of a genomic test to estimate the risk of recurrence following surgery for patients with Stage I-III renal carcinoma, clear cell type that has not spread to other parts of the body.

The clear cell type of renal carcinoma is the most common type of kidney cancer in adults, affecting an estimated 25,000 people each year in the U.S. As part of the collaboration, the companies will apply the same molecular technology and clinical strategy Genomic Health used to develop its Oncotype DX breast cancer test.

• Genzyme (Cambridge, Massachusetts) said it has entered into a license agreement with Moffitt Cancer Center (Tampa) to obtain exclusive worldwide diagnostic testing rights to the discovery of the relationship of two proteins to patient response to non-small cell lung cancer (NSCLC) treatment.

The expression level of these proteins may help predict how these patients will respond to therapy. Genzyme Genetics said that its relationship with Moffitt broadens its lung cancer testing portfolio.

The expression levels of the two proteins, RRM1 and ERCC1, have been shown by Gerold Bepler, MD and his team from Moffitt, to correlate with patient response to platinum drugs and gemcitabine, both of which are commonly used in treating NSCLC. Through this license, Genzyme plans to develop and market a diagnostic test that can be used to measure the expression levels of these proteins in NSCLC patients.

This test may be used to guide first-line treatment for these patients, which in turn may improve patient outcomes while avoiding unnecessary side effects from ineffective treatment.

• MetaMorphix (Beltsville, Maryland) and Sequenom (San Diego) reported they have strengthened their partnership through MetaMorphix’s adoption of Sequenom’s MassArray and iPLEX foundation technologies, which provide cost-effective genotyping and enhanced efficiencies.

Sequenom’s platform for animal DNA screening and selection will allow MetaMorphix to scale up quickly, increasing its ability to handle more sample volumes following successful launches of DNA-based diagnostic products for both the livestock and companion animal markets.

• NanoString Technologies (Seattle) said it has signed a second Early-Access Agreement for its nCounter Analysis System for digital gene expression with the Genome Sequencing Center at the Washington University School of Medicine.

The nCounter Analysis System uses digital technology that enables direct multi-plexed measurement of gene expression and offers high levels of sensitivity and precision, including detection of fractional fold change differences, a feature unique to this platform. The technology uses molecular barcodes and single molecule imaging to detect and count hundreds of unique transcripts in a single reaction. The system features a step-by-step guide to perform the analysis on a touch screen.

The automated system is designed for researchers seeking to validate gene expression signatures, working with small amounts of starting material or studying defined gene sets. The system is comprised of an automated sample prep station, a digital analyzer, the CodeSet (molecular barcodes) and all other reagents needed to perform the analysis. The CodeSets can assay hundreds of gene transcripts per reaction.

Washington University researchers will use the nCounter first for a large-scale diabetes study by Dr. James Cheverud to validate the expression of over 50 genes across 15 tissues in over 900 samples.