American Association for Clinical Chemistry
Better health through laboratory medicine
February 2008 Clinical Laboratory News: Industry Profiles

 February 2008: Volume 34, Number 2

Clinical Data Plans PGx Test for New Depression Drug

Clinical Data (Newton, Mass.) announced that it is working on a companion pharmacogenetic test in parallel with a safety study for its depression drug Vilazodone. Researchers will determine the long-term safety and tolerability of Vilazodone while a second trial evaluates genetic biomarkers associated with response to the drug. “With the addition of a genetic test for response to Vilazodone, we can help clinicians more quickly and confidently identify patients who are likely to respond, leading to improvements in patient care and outcomes,” said Clinical Data CEO Drew Fromkin. “This is just one example of how pharmacogenetics can lead to more targeted therapeutics and therefore better healthcare.” Clinical Data plans to submit a new drug application with the FDA for Vilazodone next year.

Pfizer and Source MDx Collaborate on Companion Diagnostics

Source MDx (Boulder, Colo.) announced a multi-year translational molecular medicine collaboration with Pfizer (New York, N.Y.) to develop RNA-based pharmacodynamic and predictive biomarkers from Pfizer’s cancer and inflammation drug programs. Combining Pfizer’s experience in genomic profiling with Source MDx’s know-how in RNA transcription profiling and circulating rare cells, researchers from the companies will work to establish molecular profiles of response and resistance for important cancer and inflammation drugs. Under the agreement, Source MDx will receive an equity investment and licensing fees, in addition to research and development funding. Source MDx will retain commercial rights to any biomarkers that the venture discovers, but both Pfizer and Source MDx can commercialize any companion diagnostics the collaboration develops.

Siemens Inks Deal with Krelo for TRAb Assay

Siemens Medical Solutions Diagnostics (Tarrytown, N.Y.) announced an agreement with KreLo GmbH Medical Diagnostics (Ulm, Germany) for rights to develop an automated stimulating TSH receptor antibody (TRAb) assay used in the differential diagnosis of Graves’ disease. “The new TRAb assay has enormous potential to help diagnose, monitor, and predict the course of Graves’ disease,” said Joe Bernardo, senior VP, Central Lab Testing, Siemens Medical Solutions Diagnostics. “Siemens continues to focus on new biomarker development opportunities, continually expanding our already comprehensive immunoassay menu and providing the diagnostic tools necessary to diagnose and treat millions of thyroid disease patients.” elements in the test. Financial terms were not disclosed.

PerkinElmer To Acquire Pediatrix Metabolic Screening Lab

PerkinElmer (Waltham, Mass.) announced it will acquire the newborn metabolic screening business of Pediatrix Medical Group (Sunrise, Fla.), including Pediatrix’s StepOne newborn screening service that targets more than 50 inherited disorders. “This acquisition would expand PerkinElmer’s capabilities to supply STAT laboratories with the most comprehensive newborn screening solutions available,” said Robert Friel, COO, PerkinElmer. “Adding laboratory capabilities should strengthen the partnership with our existing customers by enabling us to offer supplemental screening services for disorders beyond those currently mandated by state and federal governments.” In addition, Friel said that the acquisition would enable PerkinElmer to provide supplemental support services, such as backup screening in case of emergencies. Details of the cash transaction were not disclosed.

Firms Roll Out Retail Nutrigenomics

Consumer genomics firm GeneLink (Jersey City, N.J.) announced an exclusive, multi-year retail licensing and distribution agreement with Solgar Vitamin and Herb (Leona, N.J.) to market a nutrigenomic line of nutritional supplements. Under the agreement, Solgar will market a brand of nutritional supplements called Nutrigenomx that are tailored to individual consumers’ genes based on the results of a GeneLink DNA collection kit and Genetic Compass reporting system. The collection kits and supplements will be available at health food and specialty natural food retailers in North America.

“By combining Solgar’s leadership in nutritional sciences with GeneLink’s ten-plus years of research and advancements in consumer genomics and SNP testing, we have created an ideal marketing relationship for each of our companies,” said GeneLink CEO Monte Taylor. “A personalized approach to wellness has become an important trend in healthcare.”

ARUP Consult Wins eHealthcare Leadership Award

ARUP Laboratories (Salt Lake City, Utah) announced that its ARUP Consult Web site won a Gold 2007 eHealthcare Leadership Award for Best Design for Physician/Clinician-focused Web site, selected from more than 1,100 entries. The award recognizes Web sites from healthcare providers, health plans, healthcare associations, online health companies, pharmaceutical/medical equipment firms, suppliers, and business improvement initiatives. ARUP Consult provides free information for physicians about laboratory testing, including advice on test selection and interpretation, for more than 1,500 lab tests. “There are clear and unmistakable signs that interest in the Web and emerging technologies is hot,” said Mark Gothberg, the eHealthcare Leadership Awards chairman. “The 2007 awards program attracted a huge number of entries from a wide variety of healthcare organizations. Despite this year’s higher threshold for winning, a record  number of sites earned an award.”