A Medical Device Daily

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:

  • IDev Technologies (Houston) a developer of minimally invasive stent systems for the treatment of peripheral vascular and non-vascular diseases, reported an exclusive distribution agreement with YMed (San Diego) for sales of the VascuTrak 2 Focal Force PTA Catheter in North America and select European markets.
    The VascuTrak 2 Focal Force PTA Catheter has been engineered for the dilatation of stenoses of the peripheral vasculature and is available in a broad range of diameter sizes and lengths to address this challenging anatomy. It is approved for use in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native synthetic arteriovenous dialysis fistulae.
    The Focal Force design concentrates the forces from balloon inflation along two axial dimensions to achieve safe and effective dilatation of both soft and calcified lesions at lower balloon inflation pressures. As a result, it is believed that the incidence of barotrauma may be reduced.
  • Orthofix International (Huntersville, North Carolina) reported through its subsidiary, Orthofix (McKinney, Texas), that it has entered into a 10-year exclusive license agreement with Texas Scottish Rite Hospital for Children (TSRHC), extending their current collaboration which provides the TRUE/LOK External Fixation System to the global orthopedic market.
    Orthofix makes fixation devices for the $350 million global external fixation market. TRUE/LOK is designed to correct limb deformities, treat bone fractures and lengthen limbs using a simpler frame.
  • Physician quality reports for every practicing kidney specialist in the country will now be free to the more than 5 million patients that research healthcare providers on HealthGrades.com (Golden, Colorado) each month, according to an agreement reported between Fresenius Medical Care North America (FMCNA; Waltham, Massachusetts), a provider of dialysis products and services, and HealthGrades, a healthcare ratings company.
    Under the agreement, FMCNA will sponsor the physician-quality reports (found on HealthGrades.com) of all practicing nephrologists, to help those with kidney disease easily research and select the doctor that is best for them.
  • Milestone Scientific (Livingston, New Jersey) reported that it has expanded its U.S. and Canadian distribution network with the addition of Patterson Dental Supply (St. Paul, Minnesota).
    Patterson has the largest direct sales force in the industry, totaling approximately 1,400 sales representatives and equipment/software specialists serving the U.S. and Canada. Patterson will join Henry Schein (Melville, New York) to both market and sell on a non-exclusive basis the STA System, Milestone's painless dental injection solution, and related disposable hand pieces.