American Association for Clinical Chemistry
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December 2008 Clinical Laboratory News: Industry Profiles

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December 2008: Volume 34, Number 12

  Study to Assess Influence of Personal Genetic Testing

Four healthcare, technology, and research organizations have teamed up to assess the behavioral consequences of personal genetic testing. The study, led by Scripps Translational Science Institute and co-sponsored by Navigenics, Affymetrix, and Microsoft, will examine whether personal genetic scans inspire people to make lifestyle changes or seek further medical evaluation. “Genome scans give people considerable information about their DNA and risk of disease, yet questions have been raised if these tests are ready for widespread public use,” said Eric Topol, MD, director of Scripps Translational Research Institute and principal investigator of the study. “Our study will prospectively evaluate the effect that state-of-the-art gene scans have on people’s lifestyles, behaviors, diets, and psyches.”

The study will offer genetic scans to up to 10,000 employees, family members, and friends of the Scripps Health System in San Diego and will monitor changes in participants’ behavior over 20 years. Affymetrix will scan participants’ genomes and Navigenics will interpret results and give personalized guidance on ways to mitigate the risk of disease. Then each participant will be able to enter and store clinical and lifestyle information in an individual, online Microsoft HealthVault account. Participants can use the HealthVault account to manage their health information and share it with healthcare providers. As part of the study, researchers will use the genetic variations found in participants as a tool to examine how genes are linked to disease.

 Cypress Bioscience Launches Test Services for RA

Cypress Bioscience announced two new personalized medicine test services aimed at rheumatologists treating patients with rheumatoid arthritis. The Avise PG test supports dose optimization and therapeutic decision making for patients taking methotrexate, a common first-line therapy for RA, by measuring levels of the active metabolites of the drug. Traditionally, physicians have had to depend on a patient’s clinical signs and symptoms to optimize methotrexate therapy. The other test, Avise MCV, aids in the diagnosis and prognosis of RA. This test measures antibodies to mutated citrullinated vimentin, a protein found in the inflamed joints of patients with RA. Both are available exclusively from Cypress Bioscience and preformed at the company’s CLIA-certified lab in San Diego, Calif. “To date, rheumatology has not benefited from advances in personalized medicine to the same extent as fields such as oncology,” said R. Michael Gendreau, MD, PhD, chief medical officer at Cypress Bioscience. “Cypress Bioscience is committed to developing personalized medicine tools to help rheumatologists individualize patient care with the goal of improving both the diagnosis and treatment of rheumatologic disease.”


Northfield Labs Submits Blood Substitute for Priority Review 

Northfield Laboratories announced it has submitted a Biologics License Application (BLA) to the FDA for PolyHeme, the company’s experimental human hemoglobin-based red cell substitute. PolyHeme is intended for use for treatment in life-threatening blood loss when red blood cells are not available. Northfield also requested Priority Review from FDA, which means a 6-month review timeline instead of the usual 10 months. Northfield has been working on PolyHeme for two decades and incurred over $200 million is losses. Last year, the company reported clinical trial results that showed more trauma patients died within 30 days of receiving PolyHeme than those who received traditional care; however, the company remains optimistic. “This submission is the culmination of the development of PolyHeme for its initial clinical indication,” said Steven Gould, MD, CEO of Northfield. “We firmly believe in PolyHeme’s potential to save the lives of patients for whom blood transfusion is not an option.” By regulation, FDA has two months to review the company’s BLA and decide whether it merits Priority Review.

Aetna Gives In-Network Coverage to PGxHealth Genetic Tests

PGxHealth, a division of Clinical Data, announced that it has become an in-network provider for Aetna, gaining full coverage for its FAMILION genetic tests. These tests detect genetic mutations that recognize inherited forms of cardiac channelopathies, such as long QT syndrome, as well as cardiomyopathies. With the new in-network coverage for Aetna patients, PgxHealth now has reimbursement for the tests for an estimated 155 million people. The company is also an approved Medicare provider for its genetic testing services.