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
Mga Kaugnay na Asset
Pinakabagong Balita
Disclaimer: Ang mga kabilang sa XM Group ay nagbibigay lang ng serbisyo sa pagpapatupad at pag-access sa aming Online Trading Facility, kung saan pinapahintulutan nito ang pagtingin at/o paggamit sa nilalaman na makikita sa website o sa pamamagitan nito, at walang layuning palitan o palawigin ito, at hindi din ito papalitan o papalawigin. Ang naturang pag-access at paggamit ay palaging alinsunod sa: (i) Mga Tuntunin at Kundisyon; (ii) Mga Babala sa Risk; at (iii) Kabuuang Disclaimer. Kaya naman ang naturang nilalaman ay ituturing na pangkalahatang impormasyon lamang. Mangyaring isaalang-alang na ang mga nilalaman ng aming Online Trading Facility ay hindi paglikom, o alok, para magsagawa ng anumang transaksyon sa mga pinansyal na market. Ang pag-trade sa alinmang pinansyal na market ay nagtataglay ng mataas na lebel ng risk sa iyong kapital.
Lahat ng materyales na nakalathala sa aming Online Trading Facility ay nakalaan para sa layuning edukasyonal/pang-impormasyon lamang at hindi naglalaman – at hindi dapat ituring bilang naglalaman – ng payo at rekomendasyon na pangpinansyal, tungkol sa buwis sa pag-i-invest, o pang-trade, o tala ng aming presyo sa pag-trade, o alok para sa, o paglikom ng, transaksyon sa alinmang pinansyal na instrument o hindi ginustong pinansyal na promosyon.
Sa anumang nilalaman na galing sa ikatlong partido, pati na ang mga nilalaman na inihanda ng XM, ang mga naturang opinyon, balita, pananaliksik, pag-analisa, presyo, ibang impormasyon o link sa ibang mga site na makikita sa website na ito ay ibibigay tulad ng nandoon, bilang pangkalahatang komentaryo sa market at hindi ito nagtataglay ng payo sa pag-i-invest. Kung ang alinmang nilalaman nito ay itinuring bilang pananaliksik sa pag-i-invest, kailangan mong isaalang-alang at tanggapin na hindi ito inilaan at inihanda alinsunod sa mga legal na pangangailangan na idinisenyo para maisulong ang pagsasarili ng pananaliksik sa pag-i-invest, at dahil dito ituturing ito na komunikasyon sa marketing sa ilalim ng mga kaugnay na batas at regulasyon. Mangyaring siguruhin na nabasa at naintindihan mo ang aming Notipikasyon sa Hindi Independyenteng Pananaliksik sa Pag-i-invest at Babala sa Risk na may kinalaman sa impormasyong nakalagay sa itaas, na maa-access dito.