A Medical Device Daily

NeoGenomics Laboratories (Fort Myers, Florida) a reference lab specializing in high-complexity, cancer-specific testing, reported an exclusive agreement with Response Genetics (Los Angeles) to offer its ResponseDX: Colon and ResponseDX: Lung tests nationwide.

ResponseDX: Colon and ResponseDX: Lung are proprietary PCR-based tests in a cost-effective panel format which serve to help oncologists make optimal therapeutic treatment decisions for patients with colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

Under terms of the agreement, NeoGenomics will be the exclusive national clinical reference laboratory authorized to offer Response Genetics' tests as a complement to Response Genetics' newly formed sales team.

Response Genetics' ResponseDX panels include analysis of the K-ras (KRAS) mutation, gene expression profiling of RRM1 and up to three other patent-protected genes: ERCC1, TS, and EGFR. KRAS is a strong predictor of whether patients will respond or not respond to the common treatment regimens for these types of cancers.

KRAS is becoming a testing standard for patients with advanced or metastatic colorectal cancer. Likewise, expression results of the other genes in the ResponseDX panels can help oncologists choose among several other standard chemotherapy regimens to treat their patients specifically by the biology of their disease which allows for a more targeted intervention.

Robert P. Gasparini, NeoGenomics' president and chief scientific officer, said, "Most laboratory pundits agree that the future of clinical laboratory testing continues to move toward genomics-based technologies, such as those being pioneered by Response Genetics. We could not be more pleased than to have Response Genetics as a partner in this endeavor. We believe that the Response DX panels have the potential to quickly become the standard of care with regard to lung and colorectal cancer testing and that there will be significant interest in these new tests from both our existing and new clients."

In other agreements/contracts news:

• Clarient (Aliso Viejo, California) has entered into an agreement with the University of Pennsylvania (Philadelphia) School of Medicine's Flow Cytometry and Cell Sorting Resource Laboratory (Flow Cytometry Lab) for a multilevel educational and technical training program. The program is intended to provide the technical and professional staff at Clarient with the necessary skills to provide superior clinical service using both standard and non-standard assays.

The agreement offers quarterly on-site training by Flow Cytometry Lab personnel, which will include evaluating current procedures and education in specific routine processes, guidelines for clinical evaluation of hematologic malignancies, quality control and quality assurance procedures, and the development of programs to assure compliance with the State of California and the College of American Pathologists educational and professional requirements. In addition, Flow Cytometry Lab professionals will provide on demand consulting and technical guidance regarding equipment and educational and process issues, and will host an annual seminar on current technological topics of interest.

• Blood Cell Storage (BCSI; Seattle) reported that it has signed an option agreement to supply pH testing inserts to CaridianBCT (Lakewood, Colorado) for manufacturing into platelet storage bags for their blood collection systems.

BCSI has received permission from, and is working with CaridianBCT to develop a bag to perform the necessary evaluations suitable for FDA clearance using this bag with their integrated pH measuring probe in the U.S. The BCSI integrated pH measuring system for platelet concentrates allows non-invasive pH measuring at the blood centers and just prior to transfusion in the hospital. A reliable, fast and non-invasive pH detection method could assist inventory management as well as help to ensure that patients receive optimum quality platelet transfusions.

• Novo Innovations (Alpharetta, Georgia) said that it signed a three-year agreement with Exempla Healthcare (Denver), a system of three hospitals and a network of clinics.

Exempla has implemented Novo's agent-based healthcare exchange solution in all three of its hospitals, which will allow the organization to deliver patient data electronically to the ambulatory electronic medical record systems at affiliated physician practices. The data – including facesheets, lab results and transcribed reports – populates the patient chart in the practice EMR within minutes of being available in the hospital system.

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