Michael Samoszuk, MD
CMO
Beckman Coulter
Professional
I have been in my present position as chief medical officer since February 2012. Prior to Beckman Coulter, I worked at Ortho Clinical Diagnostics, Roche Diagnostics Corporation, Quest Diagnostics, and at the University of California at Irvine as a tenured associate professor.
Education
BA, Princeton University and Harvard College; MD, Harvard/MIT, Program in Health Sciences Technology; Post-graduate—Pathology and Laboratory Medicine—Brigham and Women’s Hospital; University of California at San Francisco; University of Southern California
Personal
“I am an active member of the California Native Plant Society. I enjoy swimming, running, and resistance training, as well as gardening with California native plants (believe it or not, a very demanding activity). My wife and I take dance lessons together and enjoy exploring new restaurants and foods. ”
If you were explaining Beckman Coulter Diagnostics to someone who is not familiar with the company, how would you characterize its primary areas of expertise? At a high level, the primary area of expertise of Beckman Coulter Diagnostics is automation of clinical laboratory testing. We are in the business of helping clinical laboratories to provide fast, accurate, and cost-effective test results that doctors and other caregivers can confidently use to diagnose and manage their patients.
More specifically, Beckman Coulter develops, manufactures, and markets products that simplify, automate, and innovate complex biomedical testing. Hospital laboratories are our core clinical diagnostic customers. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions, and monitor patients. More than 275,000 Beckman Coulter systems operate in laboratories on six continents. For nearly 80 years, our products have been making a difference in people’s lives by improving the productivity of medical professionals and supplying critical information for improving patient health and reducing the cost of care.
Your responsibilities include oversight of product development. How have Beckman Coulter’s solutions evolved in recent years to address changing customer needs? Beckman Coulter has always been a leader in development of laboratory automation. One emerging customer need that we are now beginning to address is for a fully automated platform for viral load testing. Until now, viral load testing has been a semi-automated procedure, requiring multiple (often manual) steps for sample preparation and then nucleic acid amplification and detection. Beckman Coulter is now in the late stages of development of a fully automated platform called Veris for viral load testing that will address the changing customer need for an easier way to perform these sophisticated molecular tests. Ultimately, we hope that Veris will be able to consolidate all molecular testing onto one platform—random access, continuous access, just like labs have today for chemistry, immunoassay, and hematology.
In recent years, we have also begun to focus more on meeting changing customer needs with regard to assay menu. For example, we have invested in developing an improved assay for troponin to diagnose myocardial infarction; a new immunoassay for vitamin D; and an innovative new assay called AMH for assessing ovarian reserve. We are also now investing in developing innovative assays to address other, significant, unmet medical needs that will benefit from new diagnostic solutions.
Clinical lab leaders are talking a great deal about workflow management. How does Beckman Coulter address this increasing need? We have invested significantly in workflow management solutions to help our customers increase their efficiency, quality, and speed. As an example of our focus in this area, we support chemistry, immunoassay, hematology, and coagulation testing on our Power Express platform, enabling a single point of entry with complete sample management for these disciplines. In addition, we have developed Extended Quality Control software as part of our middleware, offering improved confidence in results by statistically monitoring each analyzer’s results between QC runs and temporarily suspending testing on any analyzer that is generating questionable results. This has the added benefit of enabling labs to space their QC runs out further, reducing costs and increasing throughput. As a final example, Beckman Coulter offers one of the highest throughput families of chemistry and immunochemistry analyzers, ensuring maximum testing velocity in the smallest possible space.
What is new—or on its way—in immunoassay diagnostic testing? There are a number of exciting new developments. One emerging area is multiplex testing using a panel of biomarkers to provide a more accurate diagnosis. By itself, a test result from any one assay is sometimes not enough to establish a specific diagnosis. By combining the results from multiple immunoassays using a mathematical algorithm, however, it will be possible to make more accurate diagnoses.
I compare this situation to how the location of a caller using a cell phone is determined. Mathematical triangulation of signal intensities from multiple cell phone towers identifies the precise location of the cell phone user. In a similar manner, multiple signals from multiple tests will allow better diagnosis and management of disease. A good example is the PHI (prostate health index), which is an index created from three markers: PSA, fPSA and -2proPSA. This test, which was recently released by Beckman Coulter, is intended to be used as an aid in distinguishing prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in the 4–10 ng/mL range and negative digital rectal examination (DRE) findings.
Other new developments in immunoassays include high-sensitivity troponin assays to be used for early detection of subclinical myocardial ischemia, and biomarker panels to help diagnose mental disorders such as depression, schizophrenia, dementia, etc. Finally, I look forward to improved immunoassays for measuring estradiol and free testosterone in men. There is emerging evidence that these assays will play an increasingly important role in the diagnosis and management of men with late-onset hypogonadism (so-called “low-T”).
What are the major categories of solutions that Beckman Coulter provides for its customers? The four major categories of solutions that Beckman Coulter provides for its customers are chemistry/immunoassay; hematology/urinalysis; molecular diagnostics; and workflow/IT solutions.
The chemistry/immunoassay business unit develops and sells devices and reagents that are used to generate laboratory tests that help diagnose or manage various illnesses and assess a person’s overall health. The tests can give information about a person’s metabolism (for example, glucose levels) or the degree of injury to vital organs (such as the heart, kidneys, or liver). The tests can be performed on a variety of body fluids, including blood, urine, or cerebrospinal fluid obtained from a spinal tap.
The hematology/urinalysis business unit develops and sells devices and chemicals that detect signs of blood disease (such as anemia, leukemia, or blood infection) or abnormalities in the urine that might signal that the person has an illness such as a urinary tract infection, bladder cancer, or diabetes. These tests are often performed as part of routine health screening, but they can also be used to manage critically ill patients who are at risk for serious bleeding or infections.
The molecular diagnostics business unit is developing sophisticated tests to measure the concentration in the blood of certain viruses that cause serious illnesses such as AIDS, hepatitis B, and hepatitis C. The concentration of virus in the blood is used by the doctor to guide and monitor treatment with drugs that can control the infection.
The workflow/IT solutions business unit develops and markets automation that helps clinical laboratories in hospitals and other locations perform laboratory tests on human specimens in a safe, fast, reliable, and accurate way. In addition, the business unit helps the clinical laboratory to operate more efficiently and to process and understand the enormous amount of patient data that is produced by the laboratory each day.
At last summer’s AACC Clinical Lab Expo, your company spotlighted automation solutions. Its booth’s theme was “New laboratory challenges require new thinking.” Can you tell readers about some of these solutions and how they can benefit the clinical lab? According to Helmut Koehler, PhD, our senior vice president of workflow and IT solutions, we highlighted automation solutions to help labs manage two of their critical evolving challenges—increasing workloads and the need for bio-banking solutions. Our latest connected automation solution, Power Express, supports labs with industry leading turn-around-time and more than 2.5 times the throughput of Beckman Coulter’s Power Processor solution. Our Intelligent Sample Bank solution works seamlessly with our AutoMate 2500 family to provide complete workflow management for bio-banking from sample creation to storage to disposal.
Please tell readers about your company’s new strategic partnership with hc1.com. Is the future of lab data management “in the cloud”? Erik Johnson, our marketing director of workflow and IT solutions, informs me that we are constantly looking at ways to deploy new technology to support the goals of our customers. Data management in the cloud will certainly provide significant benefits for customers, including a reduction in on-premise computing hardware, complete data backup and rapid deployment of new features. Our partnership with hc1.com is focused on helping labs make the best use of the data already in their existing IT systems and to identify areas for improvement—whether it is in the realm of operations, customer service, financial performance, etc. Once our customers select areas for improvement, hc1.com has a suite of Continuous Process Improvement tools to drive change and sustain improvements that we believe empowers customer success.
You have an extensive background in both academia and business. How do the two skill sets complement one another? Academia and business now share a common desire to create new solutions to unmet needs. Business relies heavily on academia for fresh new ideas, while academia increasingly depends upon business for funding and commercial development of new ideas. My background in both academics and business allows me to facilitate partnerships between the two entities. In my opinion, this type of partnership leverages the strengths of both parties and is the best way to develop novel medical content.
