Grail's Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval

Dow Jones
09/24
 
 

Grail Inc. received a favorable vote from a Food and Drug Administration panel regarding premarket approval for its Galleri multi-cancer early detection test.

The cancer-detection company said the FDA's medical devices advisory committee voted 7-2, with one abstention, to greenlight a premarket approval application for Galleri.

The FDA isn't bound to the committee's recommendation, but it takes them into consideration when making the final regulatory decision. The FDA is expected to make its final ruling on Galleri's premarket approval in the coming months.

In three separate votes, the 10 voting members of the committee considered Galleri's safety, effectiveness and overall benefit-risk profile for screening and early detection of multiple types of cancer in adults aged 50 and older.

The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that don't have recommended screening today.

When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to recommended screenings, rather than as a replacement.

The FDA designated Galleri as a breakthrough device in 2018. Grail submitted its application for premarket approval on Jan. 29.

 
 

應版權方要求,你需要登入查看該內容

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10