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Genetic Analysis Systems Enter the Clinical Mainstream

Like many other diagnostic regimes that were previously restricted to large specialty laboratories, genetic analysis is entering the clinical mainstream. Smaller, simpler analyzer systems are now suitable and affordable for hospital or large physicians group labs, while some genetic test kits are becoming available for primary point of care locations such as clinics and physician offices.

The ABI PRISM 310 Genetic Analyzer from Applied Biosystems, Foster City, Calif., is an automated single-capillary genetic analyzer designed for a wide range of sequencing and fragment analysis applications and suitable for research, clinical, or forensic labs.

This system does not require gel-based samples, sets up quickly and its operation is largely automated. The system is also able to detect five dyes simultaneously to increase test speed and efficiency. Applied Biosystems says that the 310 Genetic Analyzer provides an ideal alternative to gel-based DNA analysis and that it enables users to automate applications from de novo sequencing to SNP validation and linkage mapping.

Data collection software is supplied with the system. Optional software packages support sequencing analysis and gene mapping. The optional MicroSeq software package supports comparison of the sequence of unidentified bacteria or fungi with a validated library for positive identification and taxonomic classification.

Cepheid, Sunnyvale, Calif., is introducing the GeneXpert System to the clinical market. With its sample in, answer out ease-of-use, this analyzer will move genetic assessment into the realm of routine clinical care for the first time. By automating the entire testing process in a self-contained closed cartridge, the GeneXpert System will expand genetic testing beyond the confines of hospital and laboratory settings and into physician's offices, clinics and other point-of-care settings. The GeneXpert systems ability to identify, rapidly and accurately, a wide range of infectious agents and diseases through their genetic fingerprint will give medical professionals powerful new ways to enhance patient management and care.

As genetic screening technology grows more compact and simple to implement, test kits for laboratory and point of care diagnosis for a wide range of applications are entering the international marketplace. The uses of these kits range from cancer detection and staging to human growth factor analysis to diabetes typing. Some of these kits have been approved for use in the U.S. and inevitably many more will become available in the future.

PerkinElmer Life and Analytical Sciences, Inc., Boston, Mass., produces dozens of genetic screening tests, most of which are presently marketed only outside the U.S. A few of these products, however, are approved for use in this country. For example, PerkinElmers Cerebrospinal Fluid Kit provides a sensitive and rapid method of separating and detecting oligoclonal immunoglobulin bands in unconcentrated cerebrospinal fluid using isoelectric focusing. The presence or absence of these bands is important as supporting evidence for the diagnosis of central nervous system (CNS) disorders. This kit is useful in the diagnosis of multiple sclerosis and other CNS diseases. Each kit contains 5 gels, anolyte and catholyte solutions, ammonium nitrate, silver nitrate, tungstosilicic acid, formaldehyde, precut wicks, gel blotting papers, sample blotting strips, and templates. This assay is available in either 30 or 50 kit packages.

PerkinElmers DELFIA and AutoDELFIA kits for the quantitative determination of human estradiol in serum are also available in the U.S. These are highly sensitive assays that offer convenience and speed for in vitro fertilization treatment, and enable diagnosis of post-menopausal status. All requests for estradiol can be accommodated with one assay and an IVF protocol is available to ensure rapid turnaround of results. These solid-phase , time-resolved, fluoroimmunoassays are based on competition between Eu-labeled estradiol and sample estradiol for polyclonal anti-estradiol antibodies. The analytical sensitivity of the assays is typically better than 0.05 nmol/L (13.6 pg/mL).

Another PerkinElmer diagnostic product available in this country is the AutoDELFIA C-peptide Kit for the quantitative determination of C-peptide in serum and heparin plasma. This assay is used to assess the residual -cell function in patients treated with insulin, to distinguish between type 1 and type 2 diabetes, and various other diagnostic applications in patients with abnormal insulin secretion. The analytical sensitivity of the assay is typically better than 0.015 ng/mL (4.97 pmol/L).

Definition of chromosome anomalies in prenatal, postnatal and preimplantation genetics is sometimes critical for predicting pregnancy outcome and future quality of life. Vysis, Inc., Downers Grove, Ill., a division of Abbott Laboratories, has gained FDA approval for its Aneuvysion assay, the only FDA cleared product to test for prenatal aneuploidy. Vysis offers an expansive line of DNA FISH (fluorescence in situ hybridization) probes for evaluation of chromosome anomalies in preimplantation, prenatal and postnatal genetic testing and research.

The availability of genetic analysis tools for mainstream clinical use offers exciting new prospects for timely, accurate diagnostic, screening and evaluative tasks. Paradoxically, in this realm of genetic analysis, as in so many other aspects of modern medicine, the more sophisticated biomedical technology becomes, the greater its accessibility, breadth of application and affordability.

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