Results of GRAIL's Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision Oncology
Results of GRAIL's Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision Oncology
Data Support Clinical Performance of Galleri to Detect More Aggressive Prostate Cancers
數據支持Galleri的臨床表現，可檢測更具侵略性的前列腺癌
MENLO PARK, Calif., Aug. 29, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL) a healthcare company whose mission is to detect cancer early when it can be cured, today announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology. The data support the clinical performance of the Galleri test to preferentially screen for aggressive, clinically significant prostate cancer as compared to slow-growing (indolent) cases in the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies.
加利福尼亞州門洛帕克，2024年8月29日/美通社/--GRAIL，Inc. (納斯達克: GRAL)是一家以早期癌症診斷爲使命的醫療公司，今天宣佈其Galleri多癌症早期檢測(MCED)測試在前列腺癌方面的詳細研究結果已經發表在《JCO精準腫瘤學》雜誌上。數據支持Galleri測試在傾向於篩檢侵襲性臨床意義的前列腺癌方面的臨床表現，相對於循序漸進（溫和）案例，這些數據是在循環遊離基因組圖譜大全(CCFA)和PATHFINDER研究中獲得的。
"All screening tests run the risk of overdiagnosis. In the case of prostate cancer, this is largely due to the high prevalence of low-grade, indolent cancers," said Brandon Mahal, M.D., a radiation oncologist at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and lead author of the study. "The results of this study demonstrate that the use of MCED tests in a population-based screening program is unlikely to contribute to overdiagnosis of slow-growing prostate cancers that may not need treatment. That being said, clinically validated MCED tests like Galleri reveal that when a prostate cancer signal is detected, it usually indicates aggressive disease and additional diagnostic evaluation is necessary."
「所有篩查測試都存在過度診斷的風險。就前列腺癌來說，這主要是由於低級別的、溫和的癌症普遍存在，」 邁阿密大學米勒醫學院Sylvester綜合癌症中心的放射治療學家、該研究的主要作者Brandon Mahal萬.D.如是說。 「這項研究的結果表明，在基於人群的篩查項目中使用MCED測試不太可能導致過度診斷循序漸進的前列腺癌，這些癌症可能不需要治療。也就是說，像Galleri這樣經臨床驗證的MCED測試揭示，當檢測到前列腺癌信號時，通常這表明存在侵襲性疾病，需要進行額外的診斷評估。」
The published data is from an analysis of 420 prostate cancer patients identified in the independent clinical validation portion (substudy 3) of the multi-center, case-control observational study Circulating Cell-free Genome Atlas (CCGA) study and 18 cases from the prospective intended-use PATHFINDER study. The data were previously presented at the American Association for Cancer Research (AACR) Annual Meeting in March 2024.
發表的數據來自對多中心、病例對照觀察研究獨立臨床驗證部分（子研究3）中鑑定的420名前列腺癌患者的分析 循環遊離基因組圖譜大全(CCGA) 研究以及前瞻性使用意圖 PATHFINDER 研究。這些數據此前曾在2024年3月舉行的美國癌症研究協會(AACR)年會上進行過展示。
Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9% of intermediate-grade cancers, and only 4.2% of stage I and II cancers across both studies combined. Of the detected cases, 93% were Gleason grade groups 3-5. This analysis demonstrates the MCED test preferentially detects high-grade, clinically significant prostate cancer. This is important because an MCED test, when used in addition to standard-of-care screening, should not exacerbate overdiagnosis of indolent cancers. These findings also suggest that individuals with a cancer signal detected and a prostate CSO prediction should undergo a prompt diagnostic evaluation to determine the presence of aggressive disease for which treatment is generally indicated1.
這項分析的結果顯示，通過MCED測試檢測到的前列腺癌大多是臨床意義重大的（93%是中度或高度分級的，67%是III期或IV期的）。對於檢測到的前列腺癌，腫瘤的來源癌信號（CSO）的預測準確性大於90%。兩項研究結合後，I期和II期的癌症的可檢測性爲4.2%，這與前列腺癌細胞遊離DNA文獻中的情況相符。CCGA-3分支研究中前列腺癌的測試敏感性爲11.2%。值得注意的是，MCED測試未檢測到低級別的癌症，中級別的癌症佔1.9%，而I期和II期的癌症僅佔兩個研究中的4.2%。在檢測到的病例中，93%屬於Gleason分級組3-5。這項分析表明，MCED測試優先檢測高分級、臨床意義重大的前列腺癌。這很重要，因爲MCED測試在標準篩查之外使用時，不應加重低度惡性癌症的過度診斷。這些發現還表明，具有檢測到的癌症信號和前列腺CSO預測的個體應進行及時的診斷評估，以確定是否存在需要進行通常治療的侵襲性疾病1。
"This prostate cancer analysis underscores the power of Galleri in a general population of men at-risk for prostate cancer as it is able to detect biologically significant cancers that need treatment without potentially contributing to the burden of overdiagnosis," said Dr. Eric Klein, Distinguished Scientist at GRAIL and an author on the study. "The very high accuracy of the cancer signal origin prediction for prostate cancer indicates the need for a prompt diagnostic work-up in those with a cancer signal detected."
GRAIL的此項前列腺癌分析凸顯了Galleri在面向患有前列腺癌風險的一般人群方面的能力，因爲它能夠檢測到需要治療的生物學上重要的癌症，而不會增加過度診斷的負擔。GRAIL爲前列腺癌的癌症信號來源預測的準確性非常高，這表明對於檢測到癌症信號的人士，需要進行及時的診斷評估。
About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.
關於GRAIL
GRAIL是一家醫療保健公司，其使命是在癌症可治癒的早期檢測出癌症。GRAIL着眼於通過使用下一代測序、大規模人群臨床研究和先進的機器學習、軟件和自動化技術，檢測和鑑定多種致命癌症類型的早期階段，以減輕全球癌症的負擔。GRAIL的靶向甲基化平台可以支持篩查和精準腫瘤學的全程關懷，包括症狀患者的多癌症早期檢測、風險分層、微小殘留病的檢測、生物標誌物亞型劃分、治療和復發監測。GRAIL總部位於加利福尼亞州門洛帕克，還在華盛頓特區、北卡羅來納州和英國設有分支機構。GRAIL, LLC是Illumina, Inc.（納斯達克代碼: ILMN）的子公司，按照歐洲委員會的《臨時措施法令》的規定，目前與Illumina Inc.分開運營。
For more information, visit grail.com.
要獲取更多信息，請訪問grail.com.
About Galleri
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
關於Galleri
Galleri多癌早期檢測測試是一種預防性的工具，用於癌症篩查。通過簡單的抽血，Galleri測試可以識別癌細胞脫落的DNA，這可以作爲癌症的獨特"指紋"，有助於篩查一些今天沒有推薦篩查的最致命的癌症，如胰腺癌、食管癌、卵巢癌、肝癌等。Galleri測試可以用於在人出現症狀之前篩查癌症，當癌症可能更容易治療和潛在可治癒時。Galleri測試可以指示癌症的起源，爲醫護人員提供進一步探索的路線圖。Galleri測試需要獲得有執照的醫療保健提供者的處方，並應與推薦的癌症篩查方法（如乳房X光檢查、結腸鏡檢查、前列腺特異抗原（PSA）測試或宮頸癌篩查）一起使用。Galleri測試建議用於有癌症風險增加的成年人，如50歲或以上的人群。
For more information, visit galleri.com.
要獲取更多信息，請訪問galleri.com.
Sensitivity in study participants with –
Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
敏感性在參與者中 題爲「隨機對照試驗：kefir對患有ADHD兒童的行爲、睡眠和微生物組的影響：研究方案」的研究協議，由英國醫學雜誌（BMJ）開放雜誌發表。 該試驗將測試以飲食爲基礎的干預來針對腸道健康，以支持ADHD患兒的健康，因爲以前的研究表明，每日食用乳製品kefir中的益生菌能夠積極改變微生物組的組成，從而導致ADHD症狀減少和睡眠改善。 胰腺癌:總體敏感性爲83.7% (I期爲61.9%, II期爲60.0%, III期爲85.7%, IV期爲95.9%)。食道癌: 總體敏感性爲85.0% (I期爲12.5%, II期爲64.7%, III期爲94.7%, IV期爲100%)。卵巢癌: 總體敏感性爲83.1% (I期爲50.0%, II期爲80.0%, III期爲87.1%, IV期爲94.7%)。肝/膽管癌: 總體敏感性爲93.5% (I期爲100%, II期爲70.0%, III期爲100%, IV期爲100%)。
建議在年齡50歲或以上的高風險癌症患者中使用Galleri檢測。Galleri檢測不能檢測所有癌症，應與醫療保健提供者推薦的常規癌症篩查檢測一起使用。Galleri旨在檢測癌症信號並預測癌症信號在身體的哪個部位。不建議孕婦、21歲以下的人或正在接受積極的癌症治療的個體使用Galleri。
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
重要的Galleri安全信息
結果應該在醫療歷史、臨床體徵和症狀的背景下由醫療保健提供者解讀。沒有檢測到癌症信號的檢測結果不能排除癌症。檢測到癌症信號的檢測結果需要通過醫學建立的程序（例如影像學）進行確診性評估以確認癌症。
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of No Cancer Signal Detected does not rule out cancer. A test result of Cancer Signal Detected requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
如果進一步的檢測沒有確認癌症，這可能意味着癌症不存在或者檢測不足，包括由於癌症位於身體的其他部位。假陽性（在癌症不存在時檢測到癌症信號）和假陰性（在癌症存在時未檢測到癌症信號）的檢測結果確實會發生。僅限處方。
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
僅醫療使用。
Laboratory/Test Information
GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
實驗室/測試信息
GRAIL的臨床實驗室獲得了1988年臨床實驗室改進修正法案（CLIA）的認證，並獲得了美國病理學家學院的認可。Galleri測試是由GRAIL開發的，並由其確定了其性能特徵。Galleri測試尚未獲得美國食品藥品監督管理局的清除或批准。GRAIL的臨床實驗室受CLIA監管，可進行高複雜度測試。Galleri測試旨在用於臨床目的。
Forward Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, and anticipated trends in our business.
前瞻性聲明
本新聞稿包含含有前瞻性聲明。在某些情況下，您可以通過前瞻性詞語識別這些聲明，例如"目標"，"預期"，"相信"，"繼續"，"可能"，"估計"，"期望"，"打算"，"可能"，"可能"，"規劃"，"潛在"，"預測"，"應該"，"將"等用於前瞻性句子的否定形式的術語，以及其他類似的術語。這些前瞻性聲明可能包括關於我們的風險、不確定性和假設，並可能包括對未來測試或產品、技術、臨床研究、監管合規性、潛在市場機會、預期增長戰略和我們業務中預期的趨勢的預期和預測。
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors discussed under the section entitled "Risk Factors" in the Registration Statement on Form 10 filed by GRAIL (the "Form 10"), as may be further amended. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
這些聲明僅根據我們對未來事件和趨勢的當前預期和預測。有一些重要因素可能會導致我們的實際結果、活動水平、性能或成就與前瞻性聲明中所表達或暗示的結果存在重大和不利的差異，包括我們在"Form 10"文件，可能會進一步修訂，在"風險因素"部分討論的這些因素。此外，我們在一個不斷變化和快速變化的環境中運營。新的風險不時出現。我們的管理層無法預測所有風險，也無法評估所有因素對我們業務的影響的程度，以及任何因素或因素的組合可能導致實際結果、活動水平、性能或成就存在重大和不利的差異，這可能與我們可能會做出的任何前瞻性聲明中含有的結果不符。
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
前瞻性聲明涉及將來，因此受到困難預測和很多無法控制的內在不確定性、風險和環境變化的影響。雖然我們認爲前瞻性聲明所表達或暗示的期望和預測是合理的，但我們不能保證未來的結果、活動水平、表現或成就。我們的實際結果和財務狀況可能與前瞻性聲明中所示有所不同。除法律要求外，我們不承擔更新這些前瞻性聲明的任何義務，以使我們之前的聲明符合實際結果或修訂的期望，或者反映新信息或非預期事件的發生。
This press release shall not constitute an offer of any securities for sale, nor shall there be any offer, sale or distribution of securities in any jurisdiction in which such offer, sale or distribution would be unlawful prior to appropriate registration or qualification under the securities laws of such jurisdiction.
本新聞稿不構成任何證券的出售要約，也不得在任何不具備適當註冊或符合該司法管轄區證券法規定的資格的司法管轄區進行證券的發售或分銷。
References
參考
- "Initial Treatment of Prostate Cancer, by Stage and Risk Group." American Cancer Society, 22 Nov. 2023, .
- 「前列腺癌的初步治療，根據階段和風險群。」美國癌症協會，2023年11月22日，。
SOURCE GRAIL, Inc.
出處：GRAIL，Inc.
譯文內容由第三人軟體翻譯。