American Association for Clinical Chemistry
Better health through laboratory medicine
April 2007 Clinical Laboratory News: Industry Profiles

April 2007: Volume 33, Number 4

LabCorp and Pharma Company Plan Drug-Test Combo
A deal between LabCorp (Burlington, N.C.) and pharmaceutical firm ARCA Discovery, Inc. (Denver, Colo.) could turn out the first heart failure drug to hit pharmacies at the same time as a companion diagnostic test shows up on lab menus. The agreement calls for LabCorp to develop a commercial genetic test to accompany ARCA’s heart failure drug bucindolol, a beta-blocker, in parallel with ARCA’s submission of the drug to the FDA slated for later this year. The new test will identify genetic variations of the alpha-2c and beta-1 adrenergic receptors that regulate the heart. Certain genetic variants of these receptors have been associated with a positive response to bucindolol in a majority of heart failure patients, while patients with other variations experienced side effects or did not respond to the drug at all. “LabCorp’s ability to develop a scalable, commercial genetic test, backed by its extensive resources and national distribution, was ideal,” said ARCA President and CEO Richard Brewer. “We believe that our success with bucindolol and its companion genetic test can help physicians achieve a more personalized approach to treating heart failure.” Financial terms of the deal were not disclosed.
Sysmex Seals Contract with ESR Systems Firm 
Sysmex (Mundelein, Ill.) signed an agreement to market and distribute the VES-Matic Cube 200 automated ESR testing system made by Italian company Diesse Diagnostica Senese, S.p.A. (Siena). “In keeping with Sysmex America’s philosophy as a solutions provider, we believe that addition of the Diesse VES-Matic Cube system products will enhance our company’s portfolio while ensuring our customers have access to instruments that improve workflow, safety, and convenience for their clinical laboratories,” said Sysmex President John Kershaw. Sysmex said it will introduce the Diesse system later this year, and plans are being considered to integrate the VES-Matic Cube 200 into the Sysmex Network Communication System, a remote diagnostic service.
Molecular Test for Lupus in the Works
XDx, Inc. (Brisbane, Calif.) announced a collaboration with the University of Minnesota (Minneapolis) that may lead to better testing for disease progression in systemic lupus erythematosus (SLE) patients. The licensing agreement covers intellectual property related to the use of gene expression to assess patients’ SLE disease status. “The innovative approach that XDx used to develop AlloMap molecular expression testing for the management of cardiac transplant patients can be applied to the development of a diagnostic test for SLE,” said Ralph Snyderman, an XDx board member. “A major problem in the treatment of SLE is the sporadic and unpredictable nature of the disease, often leading to treatment after damage has occurred. New technologies that enable physicians to assess disease severity, anticipate flares, and to make more informed therapeutic decisions would be of tremendous value.” XDx, the University of Minnesota, and The Feinstein Institute (New York, N.Y.) also entered into a separate agreement that gives XDx access to SLE patient samples collected through an NIH-funded program to discover biomarkers of autoimmune diseases. Financial terms of the agreements were not disclosed.
Cepheid Acquires PCR-based Test Company 
Cepheid (Sunnyvale, Calif.) announced that it has acquired Sangtec Molecular Diagnostics AB (Bromma, Sweden). The $27 million cash deal brings Cepheid a portfolio of real time PCR-based molecular diagnostic kits for herpes, HBV, and other viruses. In addition to its portfolio of assays for the management of patients with compromised immune systems, the acquisition of the Swiss company will help Cepheid more quickly expand its clinical test product menu and will add a reagent manufacturing base in Europe, said Cepheid CEO John Bishop.
Ciphergen and Quest Partner on PAD Test
Building upon an agreement already underway to develop an ovarian tumor triage test, Ciphergen Biosystems (Fremont, Calif.) said it would also co-develop a test for the detection of peripheral artery disease (PAD) with Quest Diagnostics (Lyndhurst, N.J.). Ciphergen has been working with researchers at Stanford University (Palo Alto, Calif.) on the assay for PAD, a disease that in 75% of cases does not show any symptoms.