This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Ventana Receives FDA Clearance For Estrogen Receptor (ER) Image Analysis And Digital Read Application For Breast Cancer

TUCSON, Ariz., Dec. 5, 2013 /PRNewswire/ --  Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Companion Algorithm ER (SP1) 1 image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso 2 software.  With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.  

(Photo:  http://photos.prnewswire.com/prnh/20131205/LA28038)

There are two intended uses obtained with the 510(k) clearance for ER:  first, clinical use of the software algorithm to semi-quantify the ER biomarker, and second, digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. This means the pathologist will be able to digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image analysis algorithm. 

All IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510(k) clearances. Along with the Companion Algorithm ER (SP1) image analysis software, the full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying VENTANA IHC assays 3.

"The biomarkers, scanner, and image analysis software have been optimized and clinically validated to work together as a system.  Not only does this provide a powerful image analysis tool but an added level of clinical confidence," says Robert C. Babkowski MD, FCAP Chair, Department of Pathology and Laboratory Medical Director, The Stamford Hospital.

"This most recent addition of the VENTANA ER (SP1) Companion Algorithm software to our digital pathology portfolio demonstrates our continued commitment to provide our customers with the most advanced, clinically validated, pathology solutions available," says Dr. Steve Burnell, Vice President, Ventana Digital Pathology and Workflow. "It represents another significant step by Ventana in assisting pathologists with the consistent and objective interpretation of these important breast cancer biomarkers, supporting the highest standards of patient care."

Hormone receptor status is a main factor in planning breast cancer treatment.  The presence or absence of estrogen receptor (ER) and progesterone receptor (PR) status in cancer cells, along with HER2 receptor status, help guide treatment options. The Ki-67 protein test and p53 genetic mutation test are known to be excellent markers for cellular proliferation.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,070.40 +46.34 0.26%
S&P 500 2,114.49 +6.20 0.29%
NASDAQ 5,016.9290 +11.5380 0.23%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs