A Diagnostics & Imaging Week

PerkinElmer (Boston), a provider of a broad range of life sciences products, including neonatal screening systems, and Waters (Milford, Massachusetts), a supplier of mass spectrometers, have entered into a long-term collaboration with a reagent/software/mass spectrometry/liquid chromatography platform to deliver advanced newborn screening solutions.

PerkinElmer will become the exclusive distributor of the Waters Quattro micro and Waters Quattro Premier MS/MS platforms and the Alliance HPLC System for neonatal screening applications. Newborn screening for metabolic disorders has become one of the most widely accepted procedures in preventative pediatrics.

In August 2004, PerkinElmer said it "became the only company in the world" to receive clearance from the FDA for its Neogram Tandem Mass Spectrometry Kit (TMS). The TMS system is helping to drive the global standardization of metabolic screening with the capability to analyze more than 40 disease markers with a single blood sample, according to the company.

PerkinElmer said early detection increases treatment and management options, leading to an improved quality of life. The company provides a complete screening solution from sample collection to results reporting.

Ciphergen Biosystems (Fremont, California) reported that it has signed a collaboration agreement with the Bayer Pharmaceuticals unit of Bayer AG (Leverkusen, Germany). The research will concentrate on identifying bio-markers and developing an assay that may be used in a clinical trial in cancer. Ciphergen will analyze patient samples from Phase II trials at Ciphergen's Pharmaceutical Biomarker Discovery Center (Malvern, Pennsylvania) using its proprietary SELDI-TOF-MS platform and a method for enriching low-abundance proteins in biological fluids.

Ciphergen and Bayer will collaborate in the statistical analysis of the data to identify biomarkers predictive of response to a Bayer compound in development. Financial terms were not disclosed but include up-front fees and milestone payments.

"This agreement expands our business initiative to form collaborations with pharmaceutical companies to accelerate and streamline clinical development of new drugs through the identification of important biomarkers of drug response," said William Rich, president and CEO of Ciphergen. "The relationship with Bayer allows them to access the most advanced elements of our proteomic biomarker discovery platform with the goal of converting this research into a clinical assay that can potentially be used in upcoming efficacy trials."

Tm Bioscience (Toronto), which is focused on the commercial genetic testing market, said it has signed a master purchase agreement to supply Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) with a suite of Tag-It products.

"LabCorp is one of the foremost providers of diagnostic testing in the U.S. and now one of our largest customers," said Greg Hines, president and CEO of Tm Bioscience. "With this supply agreement, our commercial footprint reaches the majority of the U.S. population, providing us with an extensive customer base for our current and future products."

The first products covered under the agreement are Tag-It ASR reagents for use in LabCorp's Ashkenazi Jewish Panel (AJP) gene assay, a single genetic test that combines mutation detection for eight disease states into one assay.

The AJP assay detects gene mutations associated with Tay-Sachs disease, Canavan disease, familial dysautonomia, Gaucher disease, Bloom syndrome, Fanconi anemia, Neimann-Pick disease and mucolipidosis Type IV.

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