Boston Biomedica awarded NIH grant to develop new collection method for TB samples
Boston Biomedica, of Bridgewater, Mass., has been awarded a Phase I Small Business Innovation Research (SBIR) grant to demonstrate the feasibility of using its proprietary Pressure Cycling Technology (PCT), its Barocycler NEP2017 instrument, and its Pulse Tube sample preparation device to prepare sputum samples for diagnosis of tuberculosis. Data from this study will provide the basis for development and commercialization of an automated system and disposable device for the collection and processing of sputum for improved detection of Mycobacterium tuberculosis (Mtb).
Current diagnosis of Mtb infection is based primarily on bacterial culture of sputum or other respiratory samples. Sample processing requires the release of bacteria from the sputum and treatment with decontaminating agents, such as harsh detergents, to inactivate the rapidly growing non-mycobacteria organisms present in these samples. Unfortunately, these treatments can also kill up to 90 percent of the target mycobacteria, significantly limiting the sensitivity and reliability of these methods. The company intends to develop a simplified device for collecting sputum samples and PCT processing to release the bacteria and preferentially inactivate the non-mycobacteria species. Such a device could simplify Mtb sample preparation, offer a safer closed system for handling specimens, and potentially increase testing sensitivity, resulting in both better patient management and an improved work environment for laboratory technicians.
Gene associated with retinitis pigmentosa thought to cause a form of macular degeneration
Scientists at the University of Michigan Kellogg Eye Center report in the August issue of Genomics that a gene associated with retinitis pigmentosa also causes a form of macular degeneration, a disease of the retina that causes loss of central vision in 13 million Americans. The finding raises the question of how a single gene can cause two very different diseases of the eye. The form of early-onset macular degeneration to which the RPGR gene is linked primarily affects males, marking the first time a macular degeneration gene has been mapped to the X chromosome.
The finding will ultimately help scientists understand how macular degeneration progresses to cause the loss of central vision. Retinitis pigmentosa first affects periphereal and night vision, eventually leading to total blindness. Neither disease is curable.
Our latest findings are exciting because they will help scientists understand how this gene works and how a single mutation causes macular degeneration," says researcher Radha Ayyagari, Ph.D.
| Genetic data will be used in pilot disease prevention program
Aurora Health Care, a not-for-profit Wisconsin health care provider will collaborate with PointOne Systems, a Milwaukee-based clinical genetic information systems company and the biotechnology company Third Wave Technologies of Madison, Wis., on a large-scale application of genetic medicine to cardiovascular care. The program will use genetic data to develop unique, individualized patient care plans designed to prevent the occurrence or advancement of cardiovascular disease. The first phase, beginning in August, will focus on preventing a form of blood clotting called venous thrombosis, which is the third most common cardiovascular disease in the United States. Aurora expects the program to reduce costly and potentially deadly surgical complications, thereby increasing overall patient safety and improving patient outcomes. PointOne’s clinical knowledge management software will be used to identify from among Aurora’s 72,000 cardiovascular patients those who are at risk of deep vein thrombosis (DVT), or blood-clotting in the veins of the legs. Aurora physicians will then determine which patients from this initial screening would benefit from genetic testing and individualized patient care plans. Each patient who participates in the first phase of the program will be tested, using Third Wave’s genetic analysis technology, for the presence of two genetic variations, Factor II and Factor V, that predispose patients to DVT. People with either of the factors have up to a seven-fold increased risk of DVT; those with both factors are at an 80-fold increased risk. Treatment plans may include individually tailored preventive drug therapy, lifestyle changes or both. “There are four primary benefits to using genetic information in the care of cardiovascular patients,” said Nick Turkal, M.D., Aurora’s senior clinical vice president for academic and medical affairs. “First, genetic data will better enable us to assess the risk of blood clots developing after surgery. Second, it will help us to determine which patients will receive the most benefit from anti-clotting medication. Third, it will allow clinicians to choose the best dose of medication for an individual patient based on genetic background. And fourth, it will allow us to educate individuals who are at increased risk for blood clots, and their families,” Turkal explained. |
Transmission of drug-resistant HIV infection found to more than double
In a multi-center study of more than 300 patients in ten North American cities, researchers from the University of California, San Diego (UCSD) School of Medicine found that the transmission rate of drug-resistant HIV had more than doubled over the five-year study period. In findings published in the August 8, 2002 issue of the New England Journal of Medicine, lead author Susan Little, M.D. and senior author Douglas Richman, M.D., both of UCSD, noted that resistance was present in persons receiving both sing-drug anti-retroviral therapy and those receiving multi-drug treatment.
“This points to the importance of routine drug-resistance tests for newly infected patients so that the most effective first-line treatment program can be initiated,” said Richman, who is director of the UCSD AIDS Research Institute and the Research Center for AIDS and HIV Infection at the Veterans Affairs (VA) San Diego Health Care System.
The transmission of drug-resistant HIV had been estimated in previous studies at 1 to 11 percent of newly infected patients. These new findings show an increase in prevalence of viral mutations associated with resistance increased from 8.0 percent from 1995-1998 to 22.7 percent during 1999-2000. The primary risk factor for transmission among the study’s subjects was unprotected sex between male partners.
Viral suppression was demonstrated by week 24 of therapy in all but one patient, but the median time to suppression was 56 days for those without the drug-resistant strain and 88 days for those with the drug-resistant form of the virus. The time to virologic failure was significantly shorter among those with drug-resistance. The study authors note that, “increases in the prevalence of drug-resistant virus among patients with established HIV infection may be associated with more frequent transmission of drug-resistant virus to newly infected persons in their community.” Thus, treatment strategies for patients newly infected with HIV should take into account the prevalence of transmitted drug resistance.
Dade Behring implements Chapter 11 debt restructuring
Stating that the operating business is very healthy, with six successive quarters of growth and profitability, Dade Behring of Deerfield, Ill., nonetheless filed for Chapter 11 bankruptcy protection in order to lessen its debt burden. In announcing the August 1, 2002 filing, Dade Behring predicted that the pre-packaged Chapter 11 process would be very quick, lasting approximately two months.
The debt restructuring involves a debt-to-equity swap that significantly reduces the company’s debt load, which it considered too high for the future health of the business. In a letter to customers posted on the company website, www.dadebehring.com, President and CEO Jim Reid-Anderson states that, “During the brief Chapter 11 period, it will be business as usual, and neither U.S. nor international customers will feel any impact from the filing. Under a pre-packaged Chapter 11, we will alleviate our debt load while ensuring uninterrupted products and service for our customers worldwide, fully protecting the pay and benefits of all employees, and maintaining strong relationships with our suppliers across the globe.” A special customer hotline has been set up at 1-800-948-3235.
| Inverness Medical Innovations agrees to acquisition of Wampole Labs from MedPointe
Inverness Medical Innovations, Inc. of Waltham, Mass., has announced the signing of a definitive agreement with MedPointe, Inc. to acquire that company’s Wampole Laborotories unit, located in Princeton, N.J. Under the terms of the agreement Inverness will pay approximately $70 million in cash for Wampole, which it expects to continue to generate revenues in excess of $40 million. In seeking the acquisition, Inverness had particular interest in enhancing its intellectual property and capabilities in the U.S. point of care market. Ron Zwanziger, CEO of Inverness Medical Innovations, stated, “We have now added another key strategic piece in our planned progression toward a preeminent position in the field of chronic disease management. This acquisition truly continues our transition toward expanded R&D efforts in order to continue with our goal of bringing innovative diagnostic products to market quicker. In our view, we now have a formidable presence in point-of-care diagnostics including a strong portfolio of intellectual property in point-of-care immunoassays.” |
Abbott recalls gonorrhea test kits that may give false negative results
The Food and Drug Administration (FDA) has announced the recall by Abbott Laboratories, Inc., of Abbott Park, Ill., of 32 lots of laboratory kits used to diagnose gonorrhea. According to the FDA, the kits have been shown to be unreliable because they may give false negative results. These test kits were distributed to hospitals and laboratories from Jan. 11 to June 24 2002.
“FDA is alerting the public to this recall to help protect the public health,” said FDA Deputy Commissioner Lester M. Crawford. “We want to make sure laboratories that have purchased these test kits, physicians who have ordered these tests, and people tested for gonorrhea since January receive this information so they can act upon it.”
Abbott Laboratories will reimburse expenses associated with repeat testing. People who have had a negative gonorrhea test since January 11th may wish to ask whether the test should be repeated. Abbott has notified customers to destroy remaining kits and advised that laboratories contact the health care providers they serve to determine if patients need to be re-tested. Repeat testing should be performed on a fresh specimen, not retained specimens.
According to the FDA, Abbott voluntarily recalled 32 lots of its gonorrhea test kits after learning through routine internal testing that certain lots did not meet specifications and, as a result, could report positive test results as negative. Upon further testing, Abbott determined that only 16 of these 32 lots did not meet internal release criteria. Abbott is continuing to investigate the cause of the problem.
Consumers or laboratories with questions can contact Abbott Laboratories at 1-800-527-1869. Physicians with questions on this recall should contact Abbott Laboratories at 1-866-233-0471.
Trinity Biotech completes acquisition of hemostasis division of Sigma Diagnostics
Trinity Biotech of Dublin, Ireland ahs completed the acquisition of the hemostasis division of Sigma Diagnostics, part of Sigma-Aldrich of St. Louis, Mo. The hemostasis test manufacturing will be transferred from St. Louis to Dublin.
Biopool, of Ventura, Calif., was also acquired by Trinity and is currently transferring its test manufacturing to Dublin. Trinity estimates that revenues from the combined Biopool and Sigma hemostasis businesses, in the first twelve months following the completion of the acquisition, will be approximately $19 million, comprising $11million in sales from the Sigma Diagnostic products and $8million from the Biopool products. It is expected that the acquisition of the Sigma business will be earnings neutral in 2002 and earnings enhancing in 2003.
Commenting on the completion of the acquisition, Ronan O’Caoimh, CEO of Trinity said “This acquisition represents a key strategy for the establishment of a significant market position in hemostasis. When combined with our Biopool business, Trinity will have a broad range of established products, extensive distribution channels, direct sales forces in key markets and a range of established, branded instruments on which tests can be performed. We are excited by the prospects for Trinity’s hemostasis business”.
Trinity Biotech develops, manufactures and markets over 200 diagnostic products for the point-of-care, self-testing and clinical laboratory segments of the diagnostic market.
Trinity autoimmune disease serology includes IFAs, ANA screen, cardiolipins and Rheumatoid Factor. Infectious disease serology includes C. difficile; CMV, EBV, influenza A, Legionella, Lyme, Mycoplasma, RSV, Toxoplasma, viral respiratory kit, chlamydia and gonorrhea.
Newly identified marker shows progression of prostate and colon cancer
In a University of Michigan study published in the August 1 Journal of Clinical Investigation, authors note that a protein found to interact with the gene for Huntington’s disease may also help physicians more effectively diagnose and treat patients with prostate and colon cancer. The huntintin interacting protein, or HIP1, is “unusual because it seems to be such a strong prognosticator, especially for prostate cancer,” according to Theodora S. Ross, M.D., Ph.D., an oncologist and assistant professor of internal medicine.
“We don’t find significant HIP1 expression in normal prostate epithelial cells, but as prostate cancer develops and progresses, we see a steady increase in HIP1 expression,” said Ross. “HIP1 was expressed in 50 percent of tumors from patients in the earliest stages of cancer, 88 percent of tumors from patients with localized prostate cancer, and 100 percent of patients with metastatic prostate cancer.”
“High levels of HIP1 were present in every stage of colon cancer,” Ross adds. “In melanoma, breast and ovarian cancers, the expression patterns varied, but HIP1 was consistently over-expressed.”
