ASI wins FDA bladder cancer diagnostic approval

Applied Spectral Imaging's system is an in-vitro diagnostic aid for automated and manual classification of bladder cancer cells.

Applied Spectral Imaging Ltd. (ASI) has obtained US Food and Drug Administration (FDA) approval for its GenASIs Scan & Analysis, SpotScan for the detection of chromosomal aberrations in bladder cancer.

The system is an in-vitro diagnostic aid for automated and manual classification of bladder cancer cells. Cells of interest are targeted based on color size and their signals pattern assisting in the diagnosis of bladder carcinoma in patients with hematuria.

ASI CEO Limor Shiposh told "Globes", "The test aims to diagnose the status of the cancer on the basis of certain genes within the chromosome of the tumor. The objective it to test whether the cancer is aggressive, in order to determine treatment."

Shiposh added that there was a short of pathologists, and that while the company's test does not replace them, it can expedite their work. Another advantage of the system is its ability to save the sample image over time, in contrast to manually scanned samples that degrade.

ASI is based on Migdal Ha'Emek and has offices in California and Germany. The company already has FDA clearance for its HER2/neu, CEP XY diagnostic aid for breast cancer, and its UroVysion test for the detection of cells in urine specimens. The company is increasingly focusing on the pathology market, especially cancer tests, as part of its strategic plan.

ASI does not disclose the size of its business, but says that it has 70 employees at its three offices, and that it has 50 distribution contracts. It has financed its operations from revenue since its last financing round in 2000.

Although ASI has not immediate need of cash, it has twice tried to hold an IPO on the Tel Aviv Stock Exchange (TASE). "Each time that a window of opportunity opens on the TASE, we're one of the first companies to contact it, because we have good numbers," says Shiposh. "A company is always looking for an exit, but we don’t need one to survive, and I haven’t seen companies have had great success in the latest waves of IPOs."

<1>"Globes": Your product is similar to the product of < BioView Ltd. (TASE:BIOV). Will you collaborate?

Shiposh: "BioView is a worthy competitor in some fields, especially cytogenetics, but collaboration really isn't on the agenda."

Published by Globes [online], Israel business news - www.globes-online.com - on February 1, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018