一種自動掃描顯微鏡和圖像分析系統(tǒng)，將用于幫助監(jiān)測膀胱癌復發(fā)的患者。該套系統(tǒng)已經(jīng)獲得了美國食品與藥品管理局的許可。

尤其特別的是，尿液標本使用Uysis公司的UroVysion膀胱癌復發(fā)試劑盒進行熒光原位雜交染色（FISH）之后，這種Duet系統(tǒng)可以用于檢測、分類和計數(shù)尿液標本中的細胞。該試劑盒可以監(jiān)測染色體3、7、17和9p21位點的異常。Duet系統(tǒng)是BioView有限公司的產(chǎn)品。

在此之前，Duet在造血細胞Giemsa染色、免疫組化染色、或者熒光原位雜交染色的羊膜細胞和原位雜交制備的細胞懸液，使用直接標記DNA探針檢測X、Y、13、16和21染色體異常的技術(shù)，已經(jīng)獲得了FDA的許可。

BioView總裁兼首席執(zhí)行官Opher Shapira指出：“我們的承諾是提供最先進的圖像分析系統(tǒng)，用以幫助病理學家和細胞發(fā)生學家，通過使用我們的高級運算法則，在光學視野和熒光掃描圖像之中，對感興趣的細胞進行分類和計數(shù)。我們相信BioView提供的自動系統(tǒng)，聯(lián)合使用形態(tài)學或者免疫組織化學染色方法，幫助實驗室進行廣泛的以FISH為基礎(chǔ)的基因測試，為醫(yī)務(wù)界提供重要的基因資料。”
 
FISH Scanning for Bladder Cancer
 
An automated scanning microscope and image analysis system is intended to aid the monitoring of patients for recurrence of bladder cancer. The system has been cleared by the U.S. Food and Drug Administration (FDA).

Specifically, this Duet system is for use in detecting, classifying, and counting of cells in urine specimens that are stained by fluorescence in situ hybridization (FISH) using the UroVysion bladder cancer recurrence kit of Vysis, Inc. (Downer’s Grove, IL, USA). The kit monitors chromosomal aberrations 3, 7, 17, and 9p21 locus. The Duet system is the product of BioView Ltd. (Rehovet, Israel).

The Duet was previously cleared by the FDA for hematopoietic cells stained by Giemsa stain, immunohistochemistry, or in situ hybridization (ISH) prepared from cell suspension and amniotic cells stained by FISH, using direct labeled DNA probes for chromosomes X, Y, 13, 16, and 21.

“Our commitment is to offer the most advanced image analysis systems to assist the pathologist and cytogeneticist in classifying and counting cells of interest, utilizing our advanced algorithms for both brightfield and fluorescent scanning,” noted Opher Shapira, president and CEO of BioView. “We believe that BioView offers the only automated system that enables laboratories to perform a wide range of genetic tests based on FISH technology, combined with morphology or immunohistochemical staining in order to provide important genetic data to the caregiver.”