U.S. FDA advisers back approval for Guardant's blood-based cancer test
Corrects paragraph 4 of May 23 story to say Shield is meant for CRC screening, not diagnosis, and fixes typo in paragraph 7. The errors were also made in previous versions.
By Puyaan Singh and Leroy Leo
May 23 (Reuters) -Advisers to the U.S. Food and Drug Administration on Thursday recommended for the approval of Guardant Health's GH.O blood test to detect a cancer that begins in the colon or rectum.
The panel voted seven-to-two in favor of benefits outweighing risks when using the test called Shield for colorectal cancer (CRC).
The FDA is expected to decide whether it would approve Shield later this year, Guardant Health said.
If approved, Shield could become the second blood-based test for CRC screening in the United States after Epigenomics' Epi proColon, which was approved in 2016.
"The advisory committee's strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk," Guardant co-CEO AmirAli Talasaz said.
CRC occurs in about 150,000 patients in the U.S. annually and is the second-leading cause of cancer fatalities in the country with more than 50,000 deaths each year, according to the FDA.
Currently, colonoscopy is considered the gold standard test for colon cancer, but adherence to it is low because it is invasive. Other tests include feces-related tests, such as Exact Sciences' EXAS.O Cologuard, but blood-based tests are considered more convenient.
Panelists raised concerns that Guardant's test was not as accurate as colonoscopy, especially as Shield detected only 13% of pre-cancerous tumors called advanced adenomas.
This was also flagged by FDA's staff reviewers in briefing documents released on Tuesday.
Guardant's application for Shield was based on a study that showed the test detected 83% of colorectal cancers, while Exact's Cologuard had 92.3% sensitivity rate, according to the FDA's documents.
Shield "is better than nothing but I don't want to downplay the issue that this test is going to miss a lot of cancers", said Charity Morgan, panel member and professor in the department of biostatistics at University of Alabama.
The company expects the test will need to be repeated every one to three years, Guardant Health executive Victoria Raymond said at the meeting, but added that "colonoscopy should be the prioritized option".
Trading in the shares of the company was halted on Thursday before the meeting started.
Reporting by Puyaan Singh and Leroy Leo in Bengaluru; Editing by Arun Koyyur
Related Assets
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.
