FDA Greenlights Guardant Health's Shield Blood Test, Analyst Cautious on Adoption
FDA Greenlights Guardant Health's Shield Blood Test, Analyst Cautious on Adoption
On Monday, the FDA approved Guardant Health Inc.'s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.
週一，美國食品與藥品管理局批准了Guardant Health（納斯達克代碼：GH）的Shield血液檢測產品用於對風險平均的45歲及以上成年人進行結直腸癌（CRC）篩查。
The company says it is the first blood test approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield like all other non-invasive methods recommended in screening guidelines.
該公司表示，Shield是FDA批准的第一種原發篩查CRC的血液檢測產品，意味着醫療保健提供者可以像使用所有其他非侵入性篩查方法一樣提供Shield。
Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.
Shield也是第一種符合Medicare覆蓋要求的CRC血液檢測產品。
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early.
儘管早期發現具有高度可治癒性，但結直腸癌是美國癌症相關死亡的第二大原因。
The American Cancer Society estimates that more than 150,000 people will be diagnosed with CRC in 2024, and the disease will be responsible for more than 53,000 deaths.
美國癌症協會估計，2024年將有超過15萬人被診斷爲CRC，而這種疾病將導致超過5.3萬人死亡。
When colon cancer is found at an early stage before it has spread, the five-year relative survival rate is 91%. If the cancer has spread to distant body parts, the five-year relative survival rate is 14%.
當結腸癌在早期階段發現並未蔓延時，五年相對生存率爲91%。如果癌症蔓延到身體的遠部位，五年相對生存率只有14%。
The FDA decision follows a recommendation for approval by an Advisory Committee panel in May 2024.
這項FDA的決定是在2024年5月的諮詢委員會建議獲得批准之後作出的。
The approval was based on the results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults.
批准是基於ECLIPSE的結果的，這是一項評估檢測CRC在風險平均的成年人中表現的註冊研究，涉及超過20,000名患者。
Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for detecting CRC, with 90% specificity for advanced neoplasia. This performance is within the range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.
該研究的結果發佈在2024年3月14日的《新英格蘭醫學雜誌》上，表明Shield對於檢測CRC的敏感性爲83%，先進新生物的特異性爲90%。這種性能處於當前指南推薦的非侵入性篩查方法的範圍內，其中總體CRC敏感性範圍爲74%至92%。
William Blair notes the bullish sentiment should be tempered for now. The product label contains several barriers to commercialization, including:
William Blair注意到，現在看好的情緒應適度，產品標籤中含有幾個商業化障礙，包括：
- A precaution statement on the first page highlights limited detection of Stage I colorectal cancer and precancerous lesions.
- A limitation is advising providers to discuss the most appropriate screening test with patients based on their medical history and individual circumstances.
- Detailed information to assist in shared decision-making with patients, including a lengthy statement on the test's limitations.
- 第一頁的預防聲明強調對I期結腸癌和癌前病變的檢測能力有限。
- 限制是建議醫療保健提供者根據患者的醫療史和個別情況討論最適合的篩查測試。
- 提供詳細信息，以協助與患者的共同決策，包括一份關於測試侷限性的詳細聲明。
Overall, these limitations may hinder the test's adoption in the already compliant screening population.
總的來說，這些限制可能會妨礙已經遵守篩查的人群接受測試。
The analyst maintains the Outperform rating for Guardant Health.
分析師維持對Guardant Health的跑贏業績評級。
Guardant Health's Shield blood test competes with Exact Sciences Inc's (NASDAQ:EXAS) Cologuard, a stool DNA-based colorectal cancer screening test for average-risk individuals 45 or older.
Guardant Health的Shield血液檢測產品與Exact Sciences Inc.（納斯達克代碼：EXAS）的Cologuard競爭，後者是一種基於糞便DNA的結直腸癌篩查，適用於年齡在45歲或以上的風險平均人群。
Price Action: GH stock is up 5.42% at $34.79 at last check Monday.
股票價格：截至週一的最後一次查詢，GH股價上漲了5.42%，至34.79美元。
Image by PDPics from Pixabay
來自Pixabay的PDPics圖片
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