Abbott’s portfolio of companion diagnostic tests includes the PathVysion HER-2 DNA Probe Kit, which represents one of the first examples of innovations in the field of personalized medicine. The test is approved for use in selecting breast cancer patients for whom Herceptin (trastuzumab) therapy is being considered. In addition, Abbott’s Vysis ALK Break Apart FISH Probe kit was approved in 2011 for use in identifying non-small cell lung cancer patients for Pfizer’s XALKORI (crizotinib) treatment in the United States, Canada, South Korea, Japan and a number of other markets. Global commercialization continues to progress as Xalkori and Vysis ALK receive additional individual country approvals, Abbott notes.

 

“Our collaboration with GSK was expanded in November 2011. The existing agreements focused on the development of PCR tests to screen non-small cell lung cancer and melanoma tumors for expression of the MAGE-A3 antigen. Under the expanded agreement, Abbott will develop a PCR test for use on the Abbott m2000rt instrument, to screen non-small cell lung cancer tumors for the expression of the PRAME antigen. PRAME is a preferentially expressed antigen of melanoma that is expressed in 69 percent of non-small cell lung cancer cases, as well as in a wide variety of cancer types, including melanoma, breast, ovarian and bladder cancer, with limited expression in normal cells,” the spokesperson tells ddn.  

 

Abbott Molecular is a leader in molecular diagnostics—the analysis of DNA and RNA at the molecular level. Abbott Molecular’s tests can also detect subtle but key changes in patients’ genes and chromosomes and have the potential for earlier detection or diagnosis, provide information relevant to the selection of appropriate therapies, and may improve monitoring of disease progression.  

 

In an unrelated development, Abbott will collaborate with Genetics Laboratory Inc. (GenLab) on the development of a molecular diagnostic test that will be designed to rapidly detect microorganisms that cause orthopedic infections. Under terms of the agreement, Abbott, in conjunction with GenLab, will develop and commercialize the new assay for use on the PLEX-ID automated microbial identification system. In the United States, PLEX-ID is currently intended only for non-diagnostic use, but assays are now being developed for future clinical diagnostic uses.

 

PLEX-ID has the ability to rapidly identify a broad variety of microorganisms. The system is capable of generating results within five to six hours in contrast to other methods, which may take several days or longer for positive identification.  

 

“Bacteria, particularly antibiotic-resistant species such as MRSA, are very dangerous in orthopedic patients because the bacterial colonies attach to the artificial surfaces of the implants,” says Dr. Gerhard Maale, an orthopedic oncologic surgeon and an expert in orthopedic infections in the Dallas-Ft. Worth area.  

 

Maale will also serve as the medical director for the Abbott-GenLab collaboration.

 

“A molecular diagnostic test designed to detect microorganisms that cause orthopedic infections, running on the PLEX-ID, could have the ability to determine which pathogens are responsible for an infection while assessing the genetic composition and potentially antibiotic resistance,” Maale says. “This could be a major step forward in diagnosing and treating serious infections in artificial joint recipients, with the potential to provide important information to physicians that they could use to save treatment costs and improve the quality of life for these patients.”

 

According to the New England Journal of Medicine, about 800,000 knee and hip replacement procedures are performed annually in the United States, and complications related to infections occur in approximately 2 percent of those procedures. In addition, more than 70,000 joint revisions are performed annually in the United States, with greater than 15 percent of hip and 25 percent of knee revisions caused by infections. Revisions are often more expensive than the original procedure.

 

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FISH: Navigating the waters of personalized medicine  

 

PRETREATMENT: Cells or tissue are placed on a slide and treated (fixed) to stabilize cellular structures. Chemical and enzymatic procedures are employed to remove membranes, and cytoplasmic proteins that prevent access to the cells’ DNA.

 

DENATURATION: Cell DNA is exposed to high temperature in order to open the DNA, making it accessible to fluorescent-labeled probe DNA.  

 

HYBRIDIZATION: Probe is added to the sample and allowed to combine with complementary sequence of the target DNA.  

 

WASHING: Excess probe is removed post-hybridization, and a counterstain is applied to visualize the individual cells and nuclei.  

 

FISH can utilize more than one fluorescent label at one time to be able to detect multiple genes (or gene loci) in a single hybridization. Colors are counted or enumerated to determine the gene status, amplification, deletion and translocation.