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.

Respectfully,

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