News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Sysmex Preparing to Move New Molecular Assays to Market

Molecular diagnostics has the same potential to create new winners and new losers among in vitro diagnostics (IVD) manufacturers as it does to clinical labs and pathology groups. New molecular assays with the ability to dramatically improve the detection of disease and guide physicians to identify the most effective therapy for individual patients, can radically change the existing market status quo.

One example of how molecular tests can open new markets for established IVD vendors is the work underway at Sysmex Corporation to gain approval by the U.S. Food & Drug Administration (FDA) for its new instrument system, the RDI-100i, which is designed to help surgeons who treat breast cancer patients. Sysmex says that, “based on the one-step nucleic acid amplification (OSNA) method that Sysmex developed, our system for rapid detection of breast cancer lymph node metastasis (comprising the gene amplification detector RD-100i used in conjunction with the gene amplification reagent lynoamp BC) delivers results with the same level of precision as the conventional procedure in about 30 minutes.” Sysmex hopes the system can deliver a major benefit, stating “intra-operative detection of metastasis to the lymph nodes in surgery for early-stage breast cancer enables excision of the affected lymph node during the same operation, and therefore helps to lighten the burden on patients by lessening the need for resurgery while lowering the risk of recurrence.”

Last week, at the annual meeting of the American Association of Clinical Chemistry (AACC) in Washington, DC, Dark Daily was able to catch up to the Sysmex executive team from Kobe, Japan, and Mundelein, Illinois, to discuss progress of this new Sysmex molecular assay and instrument system. In Japan earlier this spring, Sysmex obtained permission from regulators in that country to introduce and sell the RDI-100i system and the breast cancer test. It is pursuing similar regulatory approvals in Europe and the United States.

There are two intriguing elements to this story. First, Sysmex has targeted cancer as major corporate product development effort. Beside breast cancer, it hopes to develop molecular assays for colon, gastric, lung, cervical, and ovarian cancers. Second, Sysmex believes that its core competencies and technologies can form the foundation of its molecular tests. For example, the Sysmex technologies for passing cells through a gate, while counting, classifying, and evaluating-used in its hematology system-provide a proven technology base upon which to develop molecular assays.

Thus, the message here for lab directors and pathologists is to pay closer attention to the molecular research and development efforts of the major in vitro diagnostics companies. As with Sysmex, each major IVD company has core competencies and technologies in clinical laboratory testing that often can be matched with molecular technologies to produce some very innovative diagnostic assays.

On another subject, at AACC this year, Sysmex Corporation hosted its customer appreciation event at the Mt. Vernon estate of George Washington. George Washington himself was on hand to greet the lab directors, pathologists, as well as the staff from Sysmex. His presence made it a memorable evening, as documented by this photograph of President Washington conversing with Dark Daily Editor Robert Michel and Deborah Michel, R.N. of The Dark Report. Always politically astute, President Washington neither “broke character” nor acknowledged the current presidential election cycle.


Robert Michel

Editor, Dark Daily

Related Items:
Automation of Examinations to Detect Breast Cancer Lymph Node Metastasis: a First in Japan

Combinational Analysis of a Whole Lymph Node by OSNA and Histology for Intra-Operative Detection of Micro-Metastases

A Tale of Two Analyzers and Other Thoughts from AACC 2008

There were plenty of new and interesting analyzers, lab tests, and other products on display this week in Washington, DC, at the exhibition during the annual meeting of the American Association of Clinical Chemistry (AACC). Dark Daily was there to take it all in and to identify emerging trends in laboratory and pathology management.

There were new instrument systems galore, because many in vitro diagnostics (IVD) manufacturers use the AACC exhibition as the place to unveil their latest generation of products. Two examples of new analyzers illustrate how technology advances are contributing to useful new capabilities.

For use in the core laboratory, Ortho-Clinical Diagnostics (OCD), a Johnson & Johnson Company (NSYE:JNJ), showed off its new VITROS 5600 Integrated System, which puts chemistry and immunoassay into a single, integrated platform. What caught Dark Daily’s attention is how this instrument incorporated Lean principles in its design and operation. For example, OCD calls it a “one-tube-in, one-tube-out” workflow guided by onboard intelligence to prioritize the next 50 tubes in the queue and handle them independently and in parallel for both chemistry and immunoassay. It has an onboard menu that will support 120 assays. Another intriguing aspect of this new instrument system is that, because it uses dry chemistry, there is no need for water or waste lines. That feature will give this instrument system an interesting appeal for laboratories that want flexibility in placing the instrument while eliminating the need for expensive remodeling to supply a water and waste line to the instrument. This instrument will be available for purchase by early 2009.

A second analyzer is designed to allow community hospitals to expand their molecular testing capabilities. HandyLab, Inc. of Ann Arbor, Michigan, was showing its Jaguar platform. This is an open system for molecular assays that will produce molecular results in 45 to 90 minutes. The random access Jaguar will perform specimen preparation, amplification, and real-time PCR automatically, using room temperature reagents. It can perform 1 to 24 samples at one time and will test up to 200 samples per nine-hour shift. The Jaguar has a competitive price and is designed to support laboratory developed tests (LDPs).

With more than 800 vendors exhibiting at the AACC event and only three days of exhibition hours, it is difficult for any single individual to get by all the booths and evaluate the innovations and new products being shown. One important trend that could be seen in walking around the exhibition is the number of new vendors showing proprietary assays and lab tests. A ballpark guess is that more than 50 firms with new lab tests were exhibiting at AACC for the first time. Also, the number of exhibitors in the international area has increased over the past year.

Finally, a personal comment. Your Dark Daily editor decided to allow himself to be tested at one of the companies offering a free test of their proprietary assay. I thought this would be an easy process, since I give blood regularly and phlebotomists always tell me I have good veins. In conversing with the phlebotomist as the draw was performed, I learned that this individual was a seven-year employee with one of the national laboratories. I also observed that, after inserting the needle in my arm, this phlebotomist was fooling around for more than 30 seconds attempting to get blood to flow from that site. I quietly encouraged her to withdraw the needle and try the other arm. That second venipuncture went successfully. By the way, as a former rugby player with more than two decades of playing experience and my share of stitches, the first attempt at venipuncture was not painful or agonizing. So Dark Daily readers can be assured that your editor was NOT traumatized, only the nearby observers were.

My comment on this experience is that it demonstrates the difficulties laboratories face in providing tip-top service to consumers. Additionally, the folks with me had a chuckle discussing about how the senior executives at that phlebotomist’s home company might react were they to learn that it was the Editor of Dark Daily and The Dark Report who experienced a less-than perfect venipuncture at the hands of their phlebotomist! It is also a reminder of the variability in care delivered to patients and why reducing such variability can give laboratories competitive advantage.

Regards and enjoy the remaining weeks of summer!

Robert Michel

Editor, Dark Daily

How Local Laboratories Can Make Money from Molecular Diagnostics

With each new advance in molecular diagnostics, local laboratories and pathology group practices find it easier to set up and offer molecular assays to their own clientele. That’s because newer generations of instruments automate steps and make it feasible to support this testing with a relatively small volume of specimens.

Challenges still remain, however. Payer coverage and reimbursement for many molecular assays remain inconsistent and unpredictable. In some cases, laboratories need technical skills which are either difficult to recruit or expensive to hire. Yet, where a molecular assay has clear clinical value, physicians want access to this test, particularly from a laboratory in their own community. It is this value added dimension to a molecular testing program which has helped a number of progressive pathology groups expand market share and revenue.

One such pathology group is ProPath of Dallas, Texas. With 30 pathologists, a cornerstone of its business strategy is to have subspecialist pathologists to serve its clients. Since the inception of molecular pathology, ProPath has reviewed new technologies and assays. It is willing to invest in three dimensions to bring up and offer specific molecular tests. It will acquire the instruments and equipment, it will hire or develop the technical expertise needed to run these tests and consult with physicians, and it will put money into a sales and marketing program to educate physicans and help them use these tests to the advantage of their patients. ProPath’s Executive Director, Krista Cruse, will present a case study at the upcoming Executive War College on Laboratory and Pathology Management and discuss ProPath’s success secrets in building a profitable molecular testing program.

To help both clinical laboratories and pathology group practices identify the best molecular testing opportunities for the marketplace they serve, Mary Steele Williams, COO & Director of Scientific Programs at the Association for Molecular Pathology, Bethesda, Maryland, will speak at the Executive War College specifically on the topic of which molecular assays are heading to market and likely to be both clinically useful to physicians and financially lucrative to the laboratories which offer such tests. In her role at the Association of Molecular Pathology, Williams gets a privileged look at emerging molecular assays, so her advice and insight can be invaluable for any laboratory wanting an insider’s view of today’s market for molecular testing.

Of course, The Dark Report has often written about the emerging business model in anatomic pathology that is now competing with local pathology groups for specimens. That is the specialty esoteric testing company. One of the most recent entrants into this category is RedPath Integrated Pathology of Pittsburgh, Pennsylvania. In the first 24 months of its business launch, it has grown to $5 million per year in revenues. RedPath’s innovation is patented technology that allows it to support both the diagnosis of cancer and the planning of treatment across multiple organ systems. The technology allows RedPath to work from a range of specimens, including traditional chemically-fixed slides, fluid aspirates, and cytology smears. Sydney F. Finkelstein, M.D., the pathologist who developed this technology and became RedPath’s founder, will be at the Executive War College to discuss how RedPath is giving community-hospital pathology groups additional molecular tools that they can use to add value to their client physicians.

As these examples demonstrate, molecular diagnostics and molecular pathology each can offer plenty of upside and opportunity for local laboratories and pathology groups. But there is also risk, because of unpredictable reimbursement and other factors. What is common to the laboratory case studies described above is that these pathology labs did careful market research. Lab directors and pathologists interested in developing a profitable, thriving molecular testing program should reserve a place at the upcoming Executive War College on May 10-11, 2007 in Miami. It’s an opportunity to meet Cruse, Williams, and Finkelstein and get first-hand access to their insights, advice, and recommendations.

PS: To get the latest news and effective strategies dealing with new trends, join us in Miami on May 10-11, 2007 for the 12th Annual Executive War College. You can access the full details using the links below. Take action today to reserve your place.

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