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Leading the Way in Disease Management
How Beckman Coulter Is Working to Solve Clinical Dilemmas Through Research and Assay Development

In the realm of healthcare, the statistics of today’s diseases are staggering. Just consider the prevalence of cardiovascular disease, ovarian cancer, anemia and prostate cancer alone—and you’ll see why diagnosis and treatment efforts are at an all-time high.


Cardiovascular disease (CVD), for example, is the number one cause of death globally; more people die annually from CVD than from any other cause.1 Ovarian cancer is the fourth-leading cause of cancer death among women in the United States and Europe. Unfortunately, less than one-fifth of ovarian cancers are diagnosed in the early stages, when the survival rate is highest.2 Today, Beckman Coulter continues its efforts to find diagnostic solutions for these and other diseases, while streamlining disease management and making a difference in the lives of patients around the world.

Scoping Out New Targets
Beckman Coulter’s investment in research and development is targeted to those conditions where the efforts can have a dramatic impact. Specifically, the company is researching:

  • Markers for diseases that pose the greatest threat to a long and healthy life
  • Markers for diseases whose prevalence is so great that they touch most families and communities around the globe
  • Markers for conditions where costs for managing patients are exceptionally high

“At Beckman Coulter, we don’t start with the markers, we start with the patients,” says Linda Felgen, director of Market Development for Beckman Coulter. “Our investments in research and development are strategically targeted at those diseases that impact a large number of patients. From there, we focus on those patients that are most at risk for adverse outcomes, searching for a diagnostic solution that can make a real difference to the patients and the healthcare system.”

This focus was evidenced clearly several years ago, when Beckman Coulter acquired Hybritech, the innovator of the Hybritech Prostate Specific Antigen (PSA). While this assay gives one indication of a prostate condition, an elevated PSA result alone doesn’t differentiate between cancer or a benign condition called prostate hyperplasia.

When Hybritech Free PSA came out a short time later, it helped clinicians to further identify the most likely cases of prostate cancer.

Today, Beckman Coulter wants to dramatically improve the differentiation between cancer and benign conditions and therefore is currently investigating isoforms of free PSA that may provide significant additional information.

“New markers may be able to help clinicians make decisions about how to treat a patient—perform a painful biopsy of the prostate or wait and monitor the condition,” says Dan Bunch, director of Strategic Marketing for Beckman Coulter’s immunoassay business. “New markers may be able to help patients avoid risky, invasive procedures.”

How Labs Can Play a Role
In the fight for better disease management and patient outcomes, physicians simply can’t do it alone.

That’s where the laboratory—and support from Beckman Coulter—comes in. “Today’s physicians need better information,” says Bunch. “Because our bodies are such complex systems, physicians are asking for more and more information from the laboratory and other diagnostic areas of the hospital. They need to work in partnership with laboratories to get useful information that will direct the best course of action.”

To ensure your laboratory is doing all it can to make new strides in disease management, consider the following tips:

  • Align Your Lab With the Right Vendor
    When choosing a laboratory partner, make sure you’re working with a company that is strategic in its focus, committed to disease management, proactive to seek out the needs of the clinical community and is likely to have the products and markers your lab will need in the future.
  • Examine Your Test Menu and Instrumentation
    Make sure your lab is running instrumentation with technology that enables you to run the most comprehensive menu possible. Then, make sure your testing menu—both the breadth and quality—will help you supply physicians with the highest quality, most sensitive and cutting-edge disease markers.
  • Become a Better Partner With Physicians
    Don’t stop at providing accurate and speedy test results. Seek out new ways to consult with your physicians by helping them select and interpret diagnostic tools that advance the patient care process. Remember to advise them on additional tests they can consider to better resolve diagnostic dilemmas.
  • Take Advantage of Educational Opportunities
    Make sure your staff is educated about new markers and new opportunities to diagnose disease. Your lab can, in turn, help educate physicians.

“I think it all comes down to seeking better patient outcomes,” says Bunch. “Any one piece of data by itself is not going to give physicians all the information they need; but if we can give them a complete picture earlier in the diagnostic process, we have a real chance to improve patient care.”

While we cannot rid the world of disease, we can strive to reduce the impact on the lives of patients. Beckman Coulter is dedicated to improving patient health and reducing the cost of care.

“At Beckman Coulter, we understand the relationship between the laboratory and the patient,” says Felgen. “We want laboratories to be recognized for their valuable contribution to the healthcare system.”

Beckman Coulter at Work
Curious about what Beckman Coulter is doing today to help make a difference in people’s lives? Check out the company’s efforts and progress on six different disease fronts:

Fertility Assessment
Challenge: For many couples, the decision to have a family is delayed until later in life. Often, at the point a couple wishes to conceive, the woman’s reproductive ability is diminished.

Potential Solution: A hormone profile including anti-mullerian hormone (AMH), inhibin B and FSH has shown promise in assessing ovarian reserve. Knowing the status of ovarian reserve may help couples make more informed decisions about the best time to start a family.3

High-Risk Pregnancy
Challenge: Preeclampsia, a disorder of pregnancy threatening the mother and the baby, can be devastating both emotionally and physically, and puts an enormous financial strain on the healthcare delivery system.4

Potential Solution: The ratio of two molecules—PIGF and sVEGF R1—shows promise to aid in evaluating women experiencing the symptoms of preeclampsia.5 Better diagnosis could help delay or prevent premature delivery of their babies. Beckman Coulter is developing and is partnered with several clinical investigators to demonstrate the clinical impact of these new diagnostic tools.

Ovarian Cancer
Challenge: Ovarian cancer is the fourth-leading cause of cancer death among women in Europe and the United States. Less than one-fifth of ovarian cancers are diagnosed in the early stages, when the survival rate is highest.2 These statistics reveal why this disease is a perfect target for new markers.

Potential Solution: An exciting new marker, total inhibin, in combination with CA 125, shows promise in helping evaluate ovarian cancer.6 With exclusive rights to Inhibin through the acquisition of Diagnostics Systems Laboratories (DSL), Beckman Coulter is focused on future solutions for improved ovarian cancer detection.

Anemia
Challenge: Anemia can impair a patient’s quality of life and lead to other serious health complications. Anemia often goes undiagnosed, striking vulnerable people—young children, pregnant women, the elderly and people with serious, chronic diseases.

Potential Solution: Anemia doesn’t have to be debilitating. Valuable diagnostic information can be obtained from a wide variety of laboratory tests, such as EPO and sTfR, making this a manageable and treatable disease.

With high-level expertise in chemistry, hematology, immunoassay and data management solutions, Beckman Coulter is uniquely positioned to provide clinicians with diagnostic tools for complete anemia disease management.

Cardiovascular Disease
Challenge: Cardiovascular disease (CVD) is the number one cause of death globally; more people die annually from CVD than from any other cause.1

Potential Solution: Beckman Coulter is highly focused on developing superior new cardiac assays to manage cardiovascular disease better. Beckman Coulter’s gold standard performing Access® AccuTnI® Troponin I assay can help identify a person’s future risk of myocardial infarction. Risk stratification using AccuTnI involves categorizing patients with unstable coronary disease into high and low risk groups—helping to determine patients who are more likely to benefit from more aggressive therapy.

Current research also reinforces the relationship of dimeric PAPP-A with acute coronary disease, including peripheral artery disease and stroke. Measuring dimeric PAPP-A may help identify patients at risk for a life-threatening event.7, 8, 9

Prostate Disease
Challenge: Prostate cancer is the most common cancer, other than skin cancers, in American men.10 PSA may be elevated in a variety of malignant and benign conditions.

Potential Solution: Beckman Coulter researchers have identified BPSA and p2PSA (more commonly known as BPH-A and [-2]proPSA, respectively)—two PSA isoforms associated with Benign Prostate Hyperplasia and prostate cancer. With exclusive rights to the two markers, Beckman Coulter may better identify those patients with greatest risk of cancer while helping other patients avoid painful biopsies.11
 

1 World Health Organization website. http://www.who.int/mediacentre/factsheets/fs317/en/ index.html.
2 Jacobs IJ. Menon U. Progress and challenges in screening for early detection of ovarian cancer. Molecular and Cellular Proteomics 2004;Feb.
3 Broekmans FJ, et al. A systematic review of tests predicting ovarian reserve and IVF outcome. Human Reproduction Update 2006;12(6):685-718.
4 http://www.preeclampsia.org/statistics.asp.
5 Levine RJ, et al. Circulating angiogenic factors and the risk for preeclampsia. N Engl J Med 2004;Feb.
6 Robertson DM, et al. Inhibins/activins as diagnostics markers for ovarian cancer. Molecular and Cellular Endocrinology 2002;191:97-103.
7 Elesber AA, et al. ACS: pregnancy associated plasma protein-A and risk stratification of patients presenting with chest pain in the emergency department. International Journal of Cardiology 2006.
8 Heeschen C, et al. ACS: pregnancy associated plasma protein-A levels in patients with acute coronary syndromes. Journal of the American College of Cardiology 2005;45:229-237.
9 Sangiorgi A, et al. Stroke: pregnancy-associated plasma protein-A is markedly expressed by monocyte-macrophage cells in vulnerable and ruptured carotid atherosclerotic plaques. Journal of the American College of Cardiology 2006;47:2201-2211.
10 American Cancer Society website http://www.cancer.org/docroot/CRI/content/CRI 2 2 1X How many men get prostate cancer 36.asp?sitearea=.
11 Mikolajczk SD, et al. The use of PSA isoforms, BPH-A and ProPSA to improve specificity of PSA tests for cancer and BPH. Clin Chem 2005.

 Posted: November 7, 2007

 
 
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