Illumina (San Diego) and the Children’s Hospital of Eastern Ontario (CHEO; Ottawa) have entered a collaboration to develop molecular diagnostics to screen newborn babies for spinal muscular atrophy (SMA) and hemoglobinopathies.

These genetic diseases can lead to fatal health conditions, but can be managed and even prevented if caught at birth. CHEO conducts screening tests for 27 diseases for the 135,000 babies born in Ontario each year. The newborn screening program is expanding its screening tests this year to also include testing for cystic fibrosis.

Illumina and CHEO will develop assays to screen newborns for SMA and hemoglobinopathies using Illumina’s VeraCode technology and run on its BeadXpress reader, scheduled for market availability before the close of the 1Q07.

Illumina will gain global commercialization rights to assays developed under the collaboration, allowing it to “take the appropriate regulatory and commercial next steps to market the tests worldwide,” Jorge Velarde, senior director of business development, said in an email response to questions from Diagnostics & Imaging Week.

Velarde said that CHEO and Illumina chose to work together because they both “recognize . . . that there are a growing number of genetic diseases that can be screened at birth and treated, or managed, if detected early. Moreover, both groups are dedicated to improving newborn health by increasing the quality and success of these tests.”

“Our research collaboration with the Children’s Hospital of Eastern Ontario has the potential to expand the screening of newborns so that dangerous inherited diseases can be diagnosed, and one day may be treated before causing permanent harm,” said Jay Flatley, president/CEO of Illumina. “Tests for spinal muscular atrophy and hemoglobinopathies are an important step in this direction, and we look forward to expanding our collaboration to other important markers of newborn health.”

Illumina’s VeraCode technology is designed to leverage the power of digital holographic codes to provide a detection method for multiplex assays. That technology, combined with Illumina’s BeadXpress reader, support the rapid detection and analysis of a wide range of assays with industry leading multiplexing capability, the company said.

In other agreements:

Luminex (Austin, Texas), a multiplex solution developer, reported the signing of a development and supply agreement with Fisher HealthCare (Hampton, New Hampshire), part of Thermo Fisher Scientific (Waltham, Massachusetts). Specific terms of the agreement were not disclosed.

The agreement provides Fisher HealthCare with access to Luminex xMAP-based technology in the U.S. and offers Luminex a new customer sales channel for xMAP-based instruments and assays.

Luminex and Fisher HealthCare said they will jointly identify promising molecular diagnostic applications for Luminex to develop and manufacture on behalf of Fisher HealthCare, taking advantage of the assay multiplexing capabilities of Luminex’s xMAP technology.

• Schering-Plough (Kenilworth, New Jersey) and OraSure Technologies (Bethlehem, Pennsylvania) reported a collaboration for the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus (HCV) utilizing OraSure Technologies’ OraQuick technology platform.

The agreement brings together OraSure – a developer of saliva diagnostics and developer and manufacturer of the OraQuick Advance Rapid HIV-1/2 Antibody Test — and Schering-Plough — which has a focus on HCV therapies.

Schering-Plough said it will reimburse OraSure for a portion of the costs incurred by OraSure to develop the rapid oral HCV test and also will provide certain promotional support in the physicians’ office market in the U.S. All sales of the HCV test will be made by OraSure, and OraSure will retain the rights to market and sell the test in all markets throughout the U.S.

The tests sold to U.S. physicians’ offices will be co-branded and will incorporate OraSure’s OraQuick tradename and “Be In Charge,” the name of Schering-Plough’s free patient support program that provides access to educational information about chronic hepatitis C and its treatment.

The agreement has an initial term of two years from the date that the test is first sold commercially.

• Inhibitex (Alpharetta, Georgia) said it has entered a license and commercialization agreement with 3M (St. Paul, Minnesota) for the development of various diagnostic products using Inhibitex’s MSCRAMM protein platform.

Inhibitex granted 3M an exclusive global license to use Clumping Factor A (ClfA), an MSCRAMM protein, in the development of diagnostic products in exchange for license fees, future milestone payments, financial support of further R&D activities and royalty payments on product sales that will exceed $4 million in cash considerations over the next five years.

3M also received a license to use additional MSCRAMM protein targets for the development of other diagnostic products.

MSCRAMM proteins are a family of proteins located on the surface of pathogenic organisms that represent viable targets for the development of therapeutic and diagnostic products. ClfA is an MSCRAMM protein that has been shown to be present on the vast majority of S. aureus strains.

Inhibitex has historically focused on the discovery, development and commercialization of antibody-based products for the prevention and treatment of serious, life-threatening infections.