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PerkinElmer to Exclusively Use Waters Mass Specs for Neonatal Screening Programs


PerkinElmer will exclusively use Waters' mass spectrometers and HPLC equipment as part of its worldwide neonatal screening program, PerkinElmer announced last week.

Under terms of the agreement, PerkinElmer will use Waters' Quattro micro and Quattro Premier MS/MS platforms and its Alliance HPLC System for its neonatal screening applications. The collaboration allows for more consistency within PerkinElmer's neonatal screening platform, and may enable PerkinElmer to get a better deal financially on mass specs, said Dan Sutherby, PerkinElmer's vice president of investor relations.

"PerkinElmer is a leader in a lot of areas, but we're not a leader in mass spec. Waters is clearly a leader in mass spec," said Sutherby. "We make all the reagents, software and other peripherals. Having this exclusive partnership with Waters makes sense because Waters is going to spend their R&D dollars to make sure the mass spec is the best that it can be."

According to Sutherby, PerkinElmer has been involved in the neonatal screening market for over 20 years. Of all babies worldwide that undergo neonatal screening for disorders, 60 to 65 percent are screened using PerkinElmer reagents and peripherals, he said.

Revenue from PerkinElmer's neonatal screening segment is expected to grow by 10 to 15 percent per year, said Sutherby. The growth has increased from 10 percent per year since the American College of Medical Genetics, followed by the US Department of Health and Human Services, declared last year that every US state should screen for at least 30 selected disorders at birth.

After the FDA last year cleared its neonatal screening kit, which uses tandem mass spectrometry, PerkinElmer was chosen by the state of California to supply the state's newborn screening program with neonatal screening kits. Since then, the company has also won a contract from Florida, and it is in discussions with the 48 remaining states to try to negotiate similar contracts.

PerkinElmer "is not a leader [in mass spec]. Waters is clearly a leader in mass spec. … Having this exclusive partnership with Waters makes sense because Waters is going to spend their R&D dollars to make sure the mass spec is the best that can be."

Though it does not have formal contracts with most states, PerkinElmer currently provides neonatal screening tools in 47 of the 50 states, Sutherby said. The company's biggest competition within the neonatal market is homebrew screening reagents, which hospitals can make themselves. Roche and Abbott also dabble in the market, along with a company called Pediatrics.

Prior to its exclusive deal with Waters, PerkinElmer used is own mass specs and mass specs from a variety of other vendors, including Waters, for its neonatal applications. Negotiations for an exclusive mass spec deal with Waters started about a year ago, according to Brian Murphy, a Waters spokesman.

Michael Yelle, senior director of clinical business operations at Waters, said that Waters had been "competing very aggressively with [other companies] for neonatal screening prior to this collaboration."

The specificity for neonatal tests comes from a robust tandem mass spec analyzer, combined with the separation power of the liquid chromatography system, Yelle said.

PerkinElmer's Sutherby said that clients who order new integrated neonatal screening systems, including mass specs, will be sold Waters' mass specs. However, if a laboratory already has another brand of mass spec and wants to order service or reagents from PerkinElmer for its neonatal screening system, it is of course welcome to do so, regardless of its brand of mass spec, he said.

PerkinElmer and Waters are not only looking at expanding their neonatal screening business within the US, following the 30-disorder mandate, but are also looking to expand globally, Sutherby said. For example, in China, PerkinElmer has joined forces with the March of Dimes and insurance companies to push the Chinese government to adopt newborn screening.

Disorders that are typically screened for at birth include phenylketonuria, hyperthyroidism, MCAD and maple syrup urine disorder. With some disorders, including PKU and maple syrup urine disorder, the treatment is a simple change in diet. However, if the change in diet is not effected within 48 hours of birth, it could lead to permanent mental retardation.

"In the states, the cost of screening for one newborn is less than 100 bucks," said Sutherby. "If you compare that with the cost of caring for, for example, a mentally challenged child, that's relatively inexpensive."

Currently, about 10 percent of newborns are screened for disorders in China, Sutherby said. Globally, about 20 percent of babies receive newborn screening to some degree.

"When we look to the future, we see so many more opportunities to help babies and to grow this business," Sutherby said.

PerkinElmer will be primarily responsible for marketing the neonatal screening systems, Murphy said.

Sutherby said that in the future, the tandem mass spec system currently used for neonatal screening may be applied to other areas as well, such as biomarkers and medical imaging.

"We believe the tandem mass spec system will converge with our biomarker system and fuel the journey toward personalized medicine," said Sutherby. "Proteomics will ultimately link with genetic screening, and our biomarkers, genetic screening and medical imaging businesses will converge within the same pool."

— Tien-Shun Lee ([email protected])

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