Tissue and cell diagnostics market reaches $7.7 billion in 2014

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With fast and effective testing techniques, the tissue and cell diagnostics market was estimated to have reached $7.7 billion in 2014 for in vitro diagnostic (IVD) and other reagents used by clinical laboratories, according to Kalorama Information. Fluorescence in situ hybridization (FISH) was a leading category, according to the healthcare market research publisher. The estimate was made in Kalorama's recent report, The World Market for Tissue Diagnostics and Cell-Based Diagnostics.

"FISH testing will see the highest growth rate among histology tests," said Bruce Carlson, Publisher of Kalorama Information. "Its ability to detect abnormalities makes it ideal in diagnosing cancer."

Speed is also a factor in the growth of fluorescence in situ hybridization testing, according to the report. Traditional chromosomal analysis utilizes a technique known as karyotyping, in which the chromosomes are stained and examined under a microscope. This process is labor intensive, subjective, and requires seven or more days for a result to be generated. Therefore chromosome analysis of cancer cells is generally performed using FISH (fluorescence in situ hybridization) technology, which enables direct visual detection of chromosomal abnormalities and quantification of abnormal cells using fluorescence-labeled probes. The probes hybridize with the target DNA of a chromosome under investigation. With FISH, it is possible to investigate DNA in its native, chromosomal form within the cell nucleus.

Many FISH assays available today are laboratory developed tests (LDTs) offered by clinical, but some IVD kits are available. The first such kit to reach the market was Vysis' FDA cleared AneuVysion FISH assay tests for changes in chromosomes 13, 18, 21, X and Y, which reached the market in the 1990s. Later came Abbott's UroVysion. Abbott reported that this was the first and only test approved by the FDA that uses DNA probes to identify up to four chromosomal abnormalities frequently associated with bladder cancer. December 2006, Abbott Molecular introduced six CE-marked DNA tests to identify chromosomal abnormalities associated with certain forms of leukemia. The FISH tests use fluorescently labeled DNA probes to detect genetic abnormalities, such as extra or rearranged chromosomes, common in patients with acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL).

Other cell based and tissue based tests (also known as histology and cytology tests) include pap smear, HPV testing, and immunohistochemistry.

SOURCE Kalorama Information

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