By Susan Heavey
WASHINGTON, Nov 18 (Reuters) - Mela Sciences Inc defended its experimental skin cancer detection system before a U.S. Food and Drug Administration advisory panel on Thursday just days after agency staff questioned the data and said a new trial should be conducted.
Representatives for the devicemaker told the FDA's outside medical advisers that its computerized system, called MelaFind, was necessary to help dermatologists decide which unusual skin lesions warranted further biopsy for possible melanoma, the most deadly form of skin cancer.
Laura Ferris, a dermatologist at the University of Pittsburgh who studied MelaFind for the company, said doctors like her 'need help in evaluating these lesions.'
'The decision to biopsy is subjective, and it's variable. Having an objective device to give me input on making that decision would be very helpful,' she told the panelists.
The company is seeking support from the advisory panel as the FDA considers whether to approve the device. Panelists will offer their final recommendation later on Thursday, although the agency will later make the final decision.
Approval is critical for Mela Sciences, which has no other products.
Shares of the Irvington, New York-based company have lost 60 percent of their value since FDA concerns were made public on Tuesday. Its shares were halted on Thursday.
FDA staff, in documents released before the panel meeting, said the device had not been studied adequately and was a public health risk because it could miss cases of melanoma.
They also urged the agency to require a new clinical study before deciding on approval.
Analysts have said it could be difficult for Mela Science to launch a brand new trial, citing a lack of resources. The company would either need to raise more cash or partner with a larger devicemaker, some said.
Agency staff will present their full analysis of the company's data later on Thursday.
Mela Sciences has taken issue with the FDA staff's findings. On Thursday it said it disagreed with the agency's interpretation and that the company and the FDA had earlier agreed on how to carry the study out.
It told panelists its device is more sensitive than physicians in picking up early melanoma. MelaFind uses a special dermoscope to view the skin through a thin layer of alcohol or oil. A digital camera in the probe captures the images before software then sorts out various patterns.
Doctors are 'missing 20 to 30 percent of those curable melanomas,' said New York University dermatologist Darrell Rigel, who spoke on behalf of Mela Sciences.
The panel's final vote on MelaFind is scheduled for 5:20 p.m. EST (2220 GMT).
Mela Sciences had already faced multiple delays in getting MelaFind to market since seeking approval in 2009, including an earlier FDA request for more data. The company said it does not know when the FDA will make its final decision.
(Reporting by Susan Heavey; Editing by Dave Zimmerman) Keywords: MELASCIENCES FDA/ (Reuters Messaging: susan.heavey.reuters.com@reuters.net, Phone: 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
WASHINGTON, Nov 18 (Reuters) - Mela Sciences Inc defended its experimental skin cancer detection system before a U.S. Food and Drug Administration advisory panel on Thursday just days after agency staff questioned the data and said a new trial should be conducted.
Representatives for the devicemaker told the FDA's outside medical advisers that its computerized system, called MelaFind, was necessary to help dermatologists decide which unusual skin lesions warranted further biopsy for possible melanoma, the most deadly form of skin cancer.
Laura Ferris, a dermatologist at the University of Pittsburgh who studied MelaFind for the company, said doctors like her 'need help in evaluating these lesions.'
'The decision to biopsy is subjective, and it's variable. Having an objective device to give me input on making that decision would be very helpful,' she told the panelists.
The company is seeking support from the advisory panel as the FDA considers whether to approve the device. Panelists will offer their final recommendation later on Thursday, although the agency will later make the final decision.
Approval is critical for Mela Sciences, which has no other products.
Shares of the Irvington, New York-based company have lost 60 percent of their value since FDA concerns were made public on Tuesday. Its shares were halted on Thursday.
FDA staff, in documents released before the panel meeting, said the device had not been studied adequately and was a public health risk because it could miss cases of melanoma.
They also urged the agency to require a new clinical study before deciding on approval.
Analysts have said it could be difficult for Mela Science to launch a brand new trial, citing a lack of resources. The company would either need to raise more cash or partner with a larger devicemaker, some said.
Agency staff will present their full analysis of the company's data later on Thursday.
Mela Sciences has taken issue with the FDA staff's findings. On Thursday it said it disagreed with the agency's interpretation and that the company and the FDA had earlier agreed on how to carry the study out.
It told panelists its device is more sensitive than physicians in picking up early melanoma. MelaFind uses a special dermoscope to view the skin through a thin layer of alcohol or oil. A digital camera in the probe captures the images before software then sorts out various patterns.
Doctors are 'missing 20 to 30 percent of those curable melanomas,' said New York University dermatologist Darrell Rigel, who spoke on behalf of Mela Sciences.
The panel's final vote on MelaFind is scheduled for 5:20 p.m. EST (2220 GMT).
Mela Sciences had already faced multiple delays in getting MelaFind to market since seeking approval in 2009, including an earlier FDA request for more data. The company said it does not know when the FDA will make its final decision.
(Reporting by Susan Heavey; Editing by Dave Zimmerman) Keywords: MELASCIENCES FDA/ (Reuters Messaging: susan.heavey.reuters.com@reuters.net, Phone: 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.