New disease registry for antiphospholipid syndrome seeks patient and physician support
A national disease registry for antiphospholipid syndrome has been established at the University of North Carolina School of Medicine in Chapel Hill, N.C. Supporters are asking patients and doctors to help develop the network by registering and providing information.

     The registry, called The Antiphospholipid Syndrome Collaborative Registry, or APSCORE, includes UNC and seven other institutions: the Hospital for Special Surgery at the Weill-Cornell School of Medicine in New York City, Johns Hopkins and Duke universities, Morehouse School of Medicine in Atlanta, Ball Memorial Hospital in Muncie, Ind., and the universities of Utah in Salt Lake City and Texas at San Antonio.

     According to Dr. Robert Roubey, associate professor of medicine at UNC and national director of the effort, disease registries can speed up understanding of what causes many illnesses, development of diagnostic tests and better treatments by boosting the number of patients and information available for study. “The antiphospholipid syndrome is an autoimmune condition in which certain abnormal antibodies are associated with blood clots, strokes and miscarriages,” Roubey said. “It affects a subset of patients with lupus, but also can affect people who don’t have lupus at all.” An estimated 15 percent to 20 percent of all patients with blood clots in their veins, up to a third of stroke patients under age 50 and somewhere between 5 percent and 15 percent of women who miscarry repeatedly suffer from the condition.

     “Our goal over five years is to enroll overall about 2,000 patients,” Roubey said. “We’re looking for about 1,500 patients with the syndrome and about 500 others who have the antibodies but have not yet suffered from a blood clot or miscarriage. APSORE will include a detailed clinical database and a repository for patient blood and DNA samples, both designed to facilitate research,” Roubey said. “It should be enormously valuable to those of us who are trying to understand this disease and before long, to patients as well.”

For more information, the registry can be reached at (919) 966-0572, or by by e-mail at [email protected].

Abbott manufacturing facility in Lake County falls short in FDA inspection
Abbott Laboratories, of Abbott Park, Ill., announced that the U.S. Food and Drug Administration (FDA) found that its Lake County diagnostic manufacturing operations is not in conformity with the Quality System Regulation (QSR). The announcement follows an inspection of the Lake County diagnostic manufacturing operations that concluded in January 2002. The inspection stemmed from a 1999 consent decree between Abbott and the FDA in which the FDA cited violations in process validation, production and process control.

     Abbott said it expects to receive a formal report from the FDA explaining its most recent decision. After a thorough review of that report, Abbott said it would have a clearer understanding of the issues.

     “We are obviously deeply disappointed with the decision,” said Richard A. Gonzalez, president and chief operating officer, Abbott Medical Products Group. “We remain committed to ensuring that the quality system meets the agency’s expectation, and that the diagnostic products impacted by the consent decree are made available to patients, laboratories, and hospitals as soon as possible.” According to company spokesperson Don Braakman, since the consent decree Abbott retained about 150 independent consultants, some of them former FDA specialists, and put more than 1,500 employees behind efforts he called “extraordinary.”

     The Lake County operation is one of five domestic and 14 worldwide diagnostic manufacturing plants operated by Abbott. Tests manufactured there that were deemed medically necessary by the FDA, including HIV, hepatitis, cardiac and thyroid tests, have remained available.

Sigma-Aldrich to discontinue in diagnostics
Sigma-Aldrich Corporation of St. Louis, Mo., has announced that it will sell substantially all of the assets of its diagnostics business. The company plans to supply customers under contract while seeking to transfer these commitments to other vendors. Sigma-Aldrich hopes to discontinue its diagnostics business before the end of 2002.

     Some catalog-based products were reclassified out of diagnostics and into the company’s scientific research unit, and will continue to be sold by Sigma-Aldrich. All remaining assets of the diagnostics business are available for sale.

 Diagnosing and treating sarcoma
New research presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in May demonstrates that oligonucleotide array analysis allows better identification of adult soft-tissue sarcoma. Using this technique, researchers were able to develop a genetic fingerprint of each sarcoma. Such fingerprinting should ultimately lead to creation of more targeted therapies to treat the disease, which takes varied forms.

     “Our findings suggest that genetic fingerprinting of adult sarcomas will be useful in cases where pathologists disagree about a diagnosis or when the appearance of tumor cells does not conclusively link them to a particular subtype,” said Robert Maki, M.D., a medical oncologist at Memorial Sloan-Kettering Cancer Center and lead investigator of the study.

     According to the American Cancer Society, approximately 8,700 new cases of soft-tissue sarcoma are diagnosed each year in adults and children in the United States. Many sarcomas look almost identical under the microscope, making it difficult to distinguish between subtypes and provide the most appropriate treatment.

     “Genetic fingerprinting technology will also enhance our ability to predict patient outcome,” said the study’s senior author, Carlos Cordon-Cardo, M.D., Ph.D., director of the Division of Pathology at Memorial Sloan-Kettering. “Because we can see which genes are turned on or off in response to therapy, the technology will help us determine whether a particular sarcoma subtype will eventually become resistant to a given treatment,” he said.

 NIH awards grant to study accuracy of single tier Lyme test
Immunetics, Inc., of Cambridge, Mass., was awarded a Phase I SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, to support a clinical trial comparison of its Lyme disease test with the two-tier protocol currently used for Lyme diagnosis. Immunetics’ test received FDA approval last year for use as a first-tier screening test. Earlier clinical trials have shown the peptide antigen termed “C6” used in the test to be a highly sensitive and specific marker for exposure to B. burgdorferi, the spirochetal agent of Lyme disease, in both U.S. and European patients. The C6 test eliminates false positive results that may be due to other conditions or to vaccination with Lymerix, the vaccine from GlaxoSmithKline.

     Immunetics will partner with researchers at Tulane University and other academic institutions under the new grant. In the clinical trial, the sensitivity of the C6 Lyme test will be measured in groups of human patients followed over time, and in nonhuman primates serving as an experimental model for human Lyme disease. The goal of the study is to determine whether the C6 test can replace the current two-tier protocol, a combination of screening and confirmatory testing for Lyme disease.

 Roche and Qiagen partner for automated gene-based testing
Roche Molecular Systems, Inc. of Pleasanton, Calif., a business area of Roche Diagnostics, and Qiagen GmbH, a wholly owned subsidiary of Qiagen, Venlo, The Netherlands, have announced a development, manufacturing and supply agreement for HCV, HBV and HIV-1 testing using PCR technology.

     The customized system will incorporate modified versions of automated sample preparation modules from QIAGEN, based on the soon to be launched QIAGEN MDx BioRobot, into a system branded as the TaqPrep. The TaqPrep will be integrated with a modified version of Roche’s Cobas TaqMan analyzer, designed to target amplification using real time PCR and nucleic acid extraction methods for the detection of infectious agents that cause various diseases. Roche Diagnostics Corporation will distribute these integrated systems in the United States to large reference laboratories processing greater than 200 PCR Hepatitis B and C and HIV test requests per day.

     The parties expect that by utilizing QIAGEN’s proprietary silica membrane technologies, extraction of both DNA and RNA can be performed on a fully automated, walk-away basis, processing up to 96 samples in only a few hours. Following nucleic acid sample extraction, processed samples will be transferred onto Roche’s Cobas TaqMan platform for amplification and detection. Specially designed hardware and software will also be utilized for positive sample tracking, integrating the entire testing process with a resulting turn-around time of less than six hours.

LabCorp acquires Dynacare
Laboratory Corporation of America of Burlington, N.C., a national clinical laboratory with 2001 revenues of $2.2 billion, and Dynacare Inc., of Dallas, Texas, with 2001 revenues of approximately $238 million, announced that they have entered into a definitive agreement under which LabCorp will acquire all of the outstanding shares of Dynacare for approximately $480 million in cash and stock. In addition, LabCorp will assume approximately $205 million in Dynacare debt in conjunction with the closing of the transaction.

     Dynacare, with 24 central laboratories, two esoteric laboratories, 115 rapid response labs and 302 patient service centers, provides clinical laboratory testing services in 21 states and two Canadian provinces.

     Dynacare is a portfolio company of private equity firm GTCR Golder Rauner, L.L.C., and has approximately 6,300 employees.