May 1, 2011 (Vol. 31, No. 9)

Diagnostic Industry Expected to Benefit from Emerging Emphasis on Proactive Screening

Even though more than half of the U.S. population is female, medical research has too often neglected the health needs of women, except perhaps for reproductive issues. This is unfortunate, as diseases have different impacts on female and male populations.

For instance, women are more likely than men to die from a stroke. Nearly twice as many women as men die from Alzheimer disease each year. And three-quarters of those who have autoimmune disorders, including lupus, multiple sclerosis and rheumatoid arthritis, are women.

In a recent Institute of Medicine (IOM) report, the Washington, D.C.-based institute found that viewing women’s health exclusively as a function of sex differences is too narrow. As medicine seeks to prioritize women’s health, testing will be an important component.

Significant progress has been made in reducing mortality for women from breast cancer, cardiovascular disease, and cervical cancer. This can be attributed in part to increased consumer demand and awareness, which has resulted in additional funding and research; improved diagnosis, screening, and treatment; and, in the case of cervical cancer, a vaccine.

More limited advances have been made in studying depression, HIV/AIDS, and osteoporosis. But few advances have been made in reducing unintended pregnancy, autoimmune diseases, maternal morbidity and mortality, alcohol and drug addiction, lung cancer, gynecological cancers other than cervical cancer, nonmalignant gynecological disorders, and Alzheimer disease. The increased attention to women’s health issues and the shortcomings of traditional medical practice have led to some changes that can impact the development of diagnostics as well as drugs for women.

As women mature, their risk for certain medical conditions increases. Proactive screenings in the form of pelvic exams, Pap tests, and certain blood tests as well as advanced diagnostics can address many key healthcare concerns along the way, and even identify diseases with few or no warning signs. The diagnostics industry is taking notice.

In the last decade or so, the number of assays introduced, including many targeting female health, has been growing at a remarkable clip. At the same time, diagnostic laboratory technology is changing dramatically, due to the publication of the human genome project and advances in functional genomics, bioinformatics, miniaturization, and microelectronics. The revolution in bioinformatics has allowed scientists to mine genetic information to derive new and hopefully better markers of some of the most pressing health problems such as breast cancer, cardiac disease, diabetes, and autoimmune disorders. This has contributed to advances in immunoassays and nucleic acid tests.

Cancer diagnostics are the fastest growing field in molecular diagnostics. An example of this is a test that will determine if a breast cancer patient will benefit from a specific chemotherapy drug. The test costs approximately $500—a small price to pay to know if a woman would or would not benefit from a treatment that will cost $25,000 to $80,000.

Tailoring diagnostics, prognostics, and treatments to women as a whole, and the individual female through personalized medicine, has the potential to improve patient outcomes. The resulting collection of more relevant clinical data and its impact on care and cost has been the driver behind the personalized medicine movement. Personalized medicine advocates expect that tailored care can improve outcomes not only through more effective treatments but also through early diagnosis, more accurate prognostic capabilities, and successful prevention efforts.

It is likely that the future for women’s health diagnostics, and diagnostic testing for both sexes, will encompass personalized medicine—harnessing what science has learned from genomics and proteomics to tailor, for the individual, approaches to prevention and care.

Overall, according to Kalorama Information’s analysis, in vitro diagnostics will continue as new biomarkers are discovered that will lead to the development of assays for diagnosis, patient prognosis and pharmacogenetics, and expansion of test menus.

Kalorama expects the world markets for women’s health diagnostic tests to experience decent growth in the near term in total. Some categories are of particular note. The world market outlook for pregnancy and ovulation testing calls for about 2% annual growth for OTC/self tests. The market for bone densitometers for female testing should be stronger, with annual growth in the 6% range. Approximately 80% of the 10 million Americans with osteoporosis are women.

Current trends in diagnostics are suited for women’s health. Getting information to caregivers and patients is a prerequisite of all lab operations. The next few years will see an intensification of the healthcare industry’s emphasis on informatics, wireless communications, data networking, and cost effective healthcare delivery. Technological advancements, specifically those in device miniaturization, data digitization, wireless communications, and the Internet will permit IVD tests and devices to maintain a central role in female disease management.

Tailoring diagnostics, prognostics, and treatments to women as a whole, and the individual female through personalized medicine, has the potential to improve patient outcomes. [Alexander Raths/]

Bruce Carlson ([email protected]) is publisher at Kalorama Information.

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