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.
周一，美国食品与药品管理局批准了Guardant Health（纳斯达克代码：GH）的Shield血液检测产品用于对风险平均的45岁及以上成年人进行结直肠癌（CRC）筛查。
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.
该公司表示，Shield是FDA批准的第一种原发筛查CRC的血液检测产品，意味着医疗保健提供者可以像使用所有其他非侵入性筛查方法一样提供Shield。
Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.
Shield也是第一种符合Medicare覆盖要求的CRC血液检测产品。
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early.
尽管早期发现具有高度可治愈性，但结直肠癌是美国癌症相关死亡的第二大原因。
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.
美国癌症协会估计，2024年将有超过15万人被诊断为CRC，而这种疾病将导致超过5.3万人死亡。
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%.
当结肠癌在早期阶段发现并未蔓延时，五年相对生存率为91%。如果癌症蔓延到身体的远部位，五年相对生存率只有14%。
The FDA decision follows a recommendation for approval by an Advisory Committee panel in May 2024.
这项FDA的决定是在2024年5月的咨询委员会建议获得批准之后作出的。
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.
批准是基于ECLIPSE的结果的，这是一项评估检测CRC在风险平均的成年人中表现的注册研究，涉及超过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%.
该研究的结果发布在2024年3月14日的《新英格兰医学杂志》上，表明Shield对于检测CRC的敏感性为83%，先进新生物的特异性为90%。这种性能处于当前指南推荐的非侵入性筛查方法的范围内，其中总体CRC敏感性范围为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，现在看好的情绪应适度，产品标签中含有几个商业化障碍，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.
- 第一页的预防声明强调对I期结肠癌和癌前病变的检测能力有限。
- 限制是建议医疗保健提供者根据患者的医疗史和个别情况讨论最适合的筛查测试。
- 提供详细信息，以协助与患者的共同决策，包括一份关于测试局限性的详细声明。
Overall, these limitations may hinder the test's adoption in the already compliant screening population.
总的来说，这些限制可能会妨碍已经遵守筛查的人群接受测试。
The analyst maintains the Outperform rating for Guardant Health.
分析师维持对Guardant Health的跑赢业绩评级。
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血液检测产品与Exact Sciences Inc.（纳斯达克代码：EXAS）的Cologuard竞争，后者是一种基于粪便DNA的结直肠癌筛查，适用于年龄在45岁或以上的风险平均人群。
Price Action: GH stock is up 5.42% at $34.79 at last check Monday.
股票价格：截至周一的最后一次查询，GH股价上涨了5.42%，至34.79美元。
Image by PDPics from Pixabay
来自Pixabay的PDPics图片
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