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 Medical Device Daily.

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:

• ev3 (Plymouth, Minnesota), focused on catheter-based technologies for the endovascular treatment of vascular diseases and disorders, and FoxHollow Technologies (Redwood City, California) reported they have entered into an agreement to conduct a joint clinical study of FoxHollow’s calcium cutting device, The RockHawk, and ev3’s SpideRX endovascular devices to seek approval for the treatment of calcified lesions in peripheral artery disease.

FoxHollow will have the exclusive right to market the two devices together in the U.S.

The SpideRX is the only available embolic protection device that permits physicians to use their guidewire of choice to access the target lesion, and also is cleared by the FDA for use in both carotid arteries and saphenous vein grafts, ev3 said.

The RockHawk device, under development, is a specialized version of FoxHollow’s SilverHawk Plaque Excision System optimized for the treatment of calcified lesions in the peripheral arteries.

John Simpson, PhD, MD, CEO of FoxHollow said, “The RockHawk was designed to treat calcified lesions, whereas the SilverHawk is indicated for general plaque excision in the peripheral vasculature. We believe the use of SpideRX with the RockHawk will improve the safety and efficacy of treating this unmet clinical need. This collaboration is a key element of our ongoing strategy to expand FoxHollow’s ability to treat peripheral artery disease.”

• Misys Healthcare Systems (Raleigh, North Carolina), a healthcare IT company, and Wellsoft (Somerset, New Jersey), focused on Emergency Department Information Systems (EDIS) software, reported a partnership to provide Misys clients with a complete IT solution that includes software for use in the emergency department.

The partnership enables Misys to offer Wellsoft EDIS as part of Misys CPR, an enterprise wide web-based solution that delivers enterprise clinical information management via integrated computerized physician order entry (CPOE).

Misys will market the solution as Misys ED featuring an integrated workflow with Misys CPR.