A Diagnostics & Imaging Week

Nanogen (San Diego) said it has been awarded a $10.4 million, two-year contract from the U.S. Centers for Disease Control and Prevention (CDC) to develop a multi-analyte molecular diagnostic assay for influenza.

This new contract will have Nanogen develop a fast molecular test that simultaneously detects and differentiates Influenza Type A, Influenza Type B, seasonal flu (H1N1 and H3N2) strains, and Respiratory Syncytial Virus (RSV). The contract provides for a secondary, "reflex" test for avian flu strains (H5N1, H7N1, and H9N1) to be available for samples that are determined to be positive for Flu A but negative for seasonal flu. RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.

The molecular diagnostic test will be developed in partnership with the Medical College of Wisconsin (Milwaukee) and HandyLab (Ann Arbor, Michigan). It will be significantly more sensitive than current rapid flu tests and is expected to be conducted in less than half the time it takes to run current molecular tests. These tests are intended as a key component of the CDC's two-pronged approach to quickly identify and respond to a potential flu pandemic.

This is the second contract the company has been awarded by the CDC related to the development of diagnostic tests for influenza and complements the rapid test currently being developed by the Company in collaboration with HX Diagnostics.

"Receiving a second significant contract from the CDC is a strong endorsement of our capabilities as a diagnostic company and clearly shows recognition for our expertise in molecular biology and infectious disease," said Howard Birndorf, Nanogen's chairman/CEO. "Additionally, this contract will increase funds for ongoing development of our market-leading, real-time PCR technology and an integrated system to improve ease of use in clinical laboratories."

He added, "Recently there have been a number of multiplexed molecular products for respiratory targets to hit the market. These products, however, are expensive and test for more pathogens than are useful in clinical diagnosis. Having a fast molecular assay that can be used as a confirmatory test for influenza will improve the tools available to clinicians for better patient health management."

In other grants/contracts news:

Micronics (Redmond, Washington), a provider of custom lab card design, development, and production services, said it has been awarded a $100,000 Small Business Innovation Research grant to advance its diagnostic test to detect Human Immunodeficiency Virus (HIV) at point of care.

The grant, from the National Institute of Allergy and Infectious Diseases under the National Institutes of Health, will help Micronics determine whether its rapid nucleic acid test to diagnose HIV is comparable in both sensitivity and specificity to the only FDA licensed diagnostic nucleic acid test in use today, the company said.

The project is expected to demonstrate the detection of HIV in a droplet of blood applied to a small disposable cassette that contains all of the required reagents and controls to perform a nucleic acid assay. John Gerdes, PhD, chief scientific officer for Micronics, will serve as the principal investigator under this award.

According to Karen Hedine, president/CEO, the current nucleic acid test method requires that a blood sample be taken and sent to a central reference laboratory for analysis, with results provided at a later date. The time lag between sample collection and result means that at-risk individuals may not be readily accessible to the caregiver once test results are known. In addition, she said, the current approach generally requires technical training, expensive, specialized equipment, a reliable power source, and expensive reagents and test kits.

• Xceed Molecular (Wellesley, Massachusetts), a developer of gene-expression analysis systems, said it has granted Gen-Probe (San Diego) and its affiliates a non-exclusive license to use Xceed's Flow-Thru Chip technology. Gen-Probe expects to incorporate the Xceed technology into its multiplexed molecular-diagnostics products.

Under terms of the agreement, Gen-Probe will pay up-front licensing and milestone fees to Xceed for non-exclusive access to Xceed's Flow-Thru Chip technology in specific fields. Gen-Probe also has the right to obtain co-exclusive rights (with Xceed) in pre-defined sub-fields.

In addition to continuing royalty payments, the agreement provides that Xceed will supply Gen-Probe with Xceed's custom TipChips, its Ziplex automated gene-expression system, and other Xceed products.

• Spectros (Portola Valley, California) reported that it signed an agreement with Caliper Life Sciences (Hopkinton, Massachusetts) allowing Caliper limited access to certain Spectros optical imaging technologies for undisclosed terms.

Spectros and its affiliates have more than 70 patents in the U.S., Europe, and Japan assigned or in-licensed, forming one of the largest biophotonics intellectual property collections. Spectros core patents cover optical spectroscopy, fluorimetry, and imaging for use in blood analysis, contrast-targeted cancer surgery, lab-on-chip systems, and benchtop life sciences equipment.