Question

Write down principle and brief history of UROVYSION BLADDER CANCER KIT (BY ABBOTT) and urinary bladder cancer.
Note: *No plagiarism

Answer 1

The FDA has approved a new indicator for in situ fluorescence testing (FISH) (UroVysion, manufactured by Vysis, a division of Abbott Laboratories, Inc.), allowing it to be used as an aid in the initial diagnosis of bladder cancer in patients with and suspected hematuria With bladder cancer.

Gene-dependent testing reveals aneuploidy of chromosomes 3, 7 and 17, and loss of the 9p21 position via FISH in urine samples.

The approval was based on the results of a multicenter study showing that the FISH test had significantly higher clinical sensitivity (68.6% versus 39.2%) but less specificity (77.7% versus 91.5%)) as urocytology in detecting bladder cancer compared to test methods / cytoscopy / Histological (gold standard).

The FDA notes that the clinical interpretation of test results must be evaluated in the context of a patient's medical history and results of other diagnostic tests. Positive FISH results in no other signs and symptoms of bladder cancer recurrence that may indicate the presence of other cancers related to the urinary tract (ureter, urethra, kidney and / or prostate in men), and additional diagnostic tests should be performed.

A negative FISH result does not exclude the presence of bladder cancer or its future development

The FISH test was first approved by the US Food and Drug Administration in 2001 for use in combination with cytoscopy to monitor relapse of transitional cell carcinoma of the bladder.

The vital signs test (Architect CTSTAT Myoglobin) assists in the early diagnosis of AMI

On January 26, the FDA approved a Myoglobin Immunoassay (Architect CTSTAT Myoglobin, manufactured by Abbott Laboratories, Inc.) to aid in the early diagnosis of acute myocardial infarction (AMI) and to assess the effectiveness of anticoagulant therapy.

PRINCIPLE

Cell genomics is a technology platform that uses known DNA sequence information to design products capable of detecting genetic changes associated with a disease. Aneuploidy - a condition in which the number of chromosomes in a cell differs from the normal diploid number (two copies of each chromosome, 46 in total) by loss or duplication of chromosomes.

Transfer - a condition in which a portion of a chromosome is cut off and then attached to another chromosome.

Deletion - a condition in which the DNA sequence along a chromosome is deleted and regions on both sides join together.

Amplification - refers to the production of additional copies of the chromosome sequence, which can be located on the same chromosome or on a different chromosome.

Directly examining the genome (all the DNA in a cell) is a sensitive and powerful way to detect cancer with minimal autonomy. Hybridization is a process by which a DNA probe is applied to cells in a water-based solution so that they can search for a target DNA sequence and bind (hybridize) to it. To initiate the hybridization process and allow the DNA probes to reach the chromosomal DNA, cells must be heated to a temperature high enough (72-75 ° C) for the double-stranded chromosomal DNA to dissolve. Once the DNA is denatured, fluorescent DNA probes (FISH probes) can be accessed that float in solution until they have stumbled upon the target DNA sequence. Since the DNA of the probe is designed to be complementary to a specific target DNA sequence, the probe will bind to it wherever it is found along the chromosome. To facilitate the fast and tight coupling of the probe and the target DNA, the temperature of the hybridization reaction is reduced to about 37-42 ° C (this removes much energy from the reaction environment which would otherwise keep the probe and the target DNA "bouncing" in the solution at a frequency High, a position that makes it very difficult for them to mate and form double-stranded particles.) Hybridization takes at least 2 hours. After hybridization, the cell samples are washed several times to remove excess DNA from the fluorescent probe that failed to hybridize for the target DNA sequence.