ORLANDO, July 30, 2002 — As part of its exhibit during the 2002 AACC annual meeting, Ortho-Clinical Diagnostics, a Johnson & Johnson Company, is highlighting its commitment to women’s health issues. This comes as the company continues to develop advances in diagnostic testing for management of osteoporosis, heart disease, ovarian and breast cancers, anemia, and infertility.
“Since we first developed the pioneering drug RhoGAM® for prevention of hemolytic disease of the newborn in 1968, our ability to help medical professionals diagnose and manage female-specific issues has significantly increased,” said Stephanie Wells, vice- president Global Franchise and Product Management, Ortho-Clinical Diagnostics, Inc. “Ortho-Clinical Diagnostics is committed to elevating the discussion of women’s health issues. In doing so, we hope that greater attention will bring more detection, monitoring, and treatment advances around the globe.”
Osteoporosis
Approximately 30 million American women over age 50 are at risk for either low bone mass or osteoporosis. This figure is expected to rise to 61 million by 20201. Because of lower bone mass, women are at a greater risk than men of developing osteoporosis. Compounding the risk is the dramatic rate of bone resorption following the onset of menopause.
Thankfully, treatments such as hormone replacement therapy and oral bisphosphonates are available to reduce the level of bone loss. Bone mineral density (BMD) imaging can be used to reveal the presence of osteopenia and osteoporosis. However, it requires time intervals of 12 to 24 months between tests to see definitive changes after treatment initiation. A complementary technology offered by Ortho-Clinical Diagnostics detects cross-linked N-Telopeptides (NTx), which measure bone resorption from urine samples, allowing physicians to monitor therapy and see results in as little as three months.
Heart Disease
Cardiovascular disease and heart attacks are the number one killers of women in developed countries throughout the world. Over 6 million women each year will die from some form of cardiovascular disease.
Compared with men, women are more likely to die from a first heart attack (42 percent for females vs. 24 percent for males) and more likely to be disabled by heart failure within six years of a heart attack (30 percent for females vs. 21 percent for males).
Supplementing Ortho-Clinical Diagnostics’ CK-MB assay, the company’s VITROS® Troponin I assay delivers more analytical and functional sensitivity3, providing greater physician confidence at critical decision points. A test for myoglobin is also under development and will round out the cardiac menu.
Ovarian Cancer
One woman out of every 55 (approximately 1.8 percent) will develop ovarian cancer some time during her life. It is the most lethal of all gynecological cancers4. Diagnosis commonly occurs once the cancer has reached an advanced stage. Closely monitoring patient therapy response is critical. Ortho-Clinical Diagnostics, in providing the VITROS® CA 125 II second-generation assay to laboratories helps ensure that the presence of this marker can be measured with high sensitivity.
Breast Cancer
It is estimated that 1.2 million new diagnoses and 500,000 deaths from breast cancer will occur this year. Seventy percent of cases occur in women who have no identifiable risk factors, and 77 percent of cases occur in women over age 505.
Through use of its VITROS® CA 15-3 assay, Ortho-Clinical Diagnostics delivers laboratories and physicians the most widely accepted standard of care in monitoring breast cancer progression and response to treatment.
Anemia
Anemia affects an estimated 400 million women throughout the world, making it the most widespread blood disorder among females6. Left undiagnosed, it can cause infertility, premature delivery in pregnant women, fainting and mental confusion.
By using Ortho-Clinical Diagnostics’ VITROS® B12 and folate assays, physicians can rapidly and accurately determine anemia status of patients. The folate assay can also be used as a RBC folate assay to identify possible folate deficiency.
Infertility
About six million American females currently face infertility problems. However, with increasing professional resources in reproductive medicine, new fertility drugs, and rapid, highly sensitive diagnostic management, more women are finding hope.
Ortho-Clinical Diagnostics has developed a range of fertility assays with broader dynamic ranges, resulting in fewer dilutions to improve turn-around time. Enhanced sensitivity in the VITROS® estradiol assay provides more assurance when critical decisions are called for during in vitro fertilization treatments. Other assays include total βhCG, progesterone, FSH, prolactin, LH, and testosterone.
“Whether through our attention to osteoporosis, cancer, infertility, or world-altering response to hemolytic disease of the newborn, we’ve made a sizeable impact on managing women’s health lifecycles,” commented Wells. “Ortho-Clinical Diagnostics is dedicated to exploring new territories and developing new technologies in this arena.”
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world's blood supply. In addition, through its VITROS® MicroSlide™ and enhanced chemiluminescence technologies, the company has transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions that promote effective diagnoses and enhance patient care. For more information, visit www.orthoclinical.com.
1 National Osteoporosis Foundation.
2 www.womenheart.org/body_pages/i-factsheet.html
3 WU AH, Apple, FS. Gilber WB, et al. National Academy of Clinical Biochemistry standards of laboratory practice; recommendations for the use of cardiac markers in coronary artery disease. Clinical Chemistry. 1999; 45:33.
4 Clinical Laboratory Products, July 2002
5 www.imagines.com/BreastHealth/statistics.asp
6 Gomez, Joan. Anemia in Women. May 2002. www.hunterhouse.com/showbook.asp?bid=170
