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Patient Reported Outcomes for GRAIL's Galleri Multi-Cancer Early Detection Blood Test Published in Lancet Oncology

Patient Reported Outcomes for GRAIL's Galleri Multi-Cancer Early Detection Blood Test Published in Lancet Oncology

GRAIL的Galleri多癌種早期檢測血液測試的患者報告結果已發表於《柳葉刀》腫瘤學。
PR Newswire ·  01/13 23:49

Analysis of Patient Reported Outcomes From PATHFINDER Indicate Minimal Patient Distress Associated with Multi-Cancer Early Detection Testing

PATHFINDER的患者報告結果分析表明,與多癌症早期檢測測試相關的患者痛苦最小。

MENLO PARK, Calif., Jan. 13, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL) a healthcare company whose mission is to detect cancer early when it can be cured, today announced that patient-reported outcomes (PRO) assessing patient perspectives from the PATHFINDER study were published in Lancet Oncology. The PATHFINDER study included secondary and exploratory outcomes with the objective of assessing PRO and perceptions of multi-cancer early detection (MCED) testing.

美國加州門洛帕克,2025年1月13日 /PRNewswire/ -- GRAIL, Inc.(納斯達克:GRAL)是一家醫療保健公司,使命是早期發現癌症,以便可以治癒,今天宣佈在《柳葉刀腫瘤學》上發佈了評估PATHFINDER研究患者觀點的患者報告結果(PRO)。PATHFINDER研究包括二級和探索性結果,旨在評估PRO和對多癌症早期檢測(MCED)測試的看法。

PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period. In the PATHFINDER study, general anxiety, distress and uncertainty after results disclosure, health-related quality of life, satisfaction with the Galleri test, and intent towards guideline-recommended screening and repeat MCED testing were assessed. Three instruments used to assess PRO included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty and positive experience at MCED test result disclosure, PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms, the Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life, and a satisfaction questionnaire.

對符合條件的PATHFINDER研究參與者進行PRO評估,這些參與者在12個月的跟蹤期內被檢測到癌症信號(CSD)或未檢測到癌症信號(NCSD)。在PATHFINDER研究中,評估了結果披露後的普遍焦慮、痛苦和不確定性、與健康相關的生活質量、對Galleri測試的滿意度以及對指南推薦的篩查和重複MCED測試的意圖。用於評估PRO的三種工具包括適應性多維癌症風險評估影響(MICRA)用於評估在MCED測試結果披露時的痛苦、不確定性和積極體驗、PRO測量信息系統(PROMIS)焦慮短表用於焦慮症狀、12項健康調查短表(SF-12v2)用於與健康相關的生活質量,以及滿意度問卷。

"Previous studies have shown that there is a temporary increase in anxiety symptoms after cancer screening, particularly for those with a test result indicating they may have cancer," said Lincoln Nadauld, MD, lead author of the study and was vice president, chief of Precision Health & Academics at Intermountain Health during the PATHFINDER study and currently CEO at Culmination Bio, Inc. "PRO results in the PATHFINDER study were consistent with other studies and showed the transient nature of the anxiety increase coupled with satisfaction with the screening and commitment to continue their standard screenings along with MCED testing. These encouraging results indicate that MCED could be a valuable tool for early detection with minimal distress for patients."

「先前的研究表明,在癌症篩查後,尤其是對於那些測試結果表明他們可能患有癌症的人,焦慮症狀會暫時增加,」研究的首席作者林肯·納道德(Lincoln Nadauld)博士表示,他在PATHFINDER研究期間是Intermountain Health的精準健康與學術部副總裁,現任Culmination Bio, Inc.的首席執行官。「PATHFINDER研究中的PRO結果與其他研究一致,顯示出焦慮增加的短暫特性,同時與篩查的滿意度和繼續進行標準篩查及MCED測試的承諾有關。這些令人鼓舞的結果表明,MCED可能成爲早期檢測的一種有價值工具,並能給患者帶來最小的痛苦。」

Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were "relieved about my test result." The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were "likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider.

總體而言,該研究表明與多癌種早期檢測(MCED)測試相關的患者痛苦非常小。大多數報告爲NCSD結果的參與者表示他們對自己的測試結果感到「寬慰」。與CSD測試結果相關的負面患者報告影響較小,並在12個月內恢復到基線水平。無論信號檢測狀態和最終診斷如何,參與者群體對MCED測試的總體滿意度均很高。大多數參與者表示,他們「很可能」/「非常可能」遵守醫生建議的未來指南推薦篩查測試。

"As the pioneer in multi-cancer early detection, GRAIL is committed to not only evaluating the performance of the Galleri test but also the impact of MCED screening on patients," said Eric Klein, MD, Distinguished Scientist at GRAIL and co-author on the study. "Collecting participant perspectives and appropriately supporting recipients of cancer screening may improve adherence rates and early detection. The patient-reported outcome findings from the PATHFINDER study suggest MCED testing is associated with a high level of satisfaction."

「作爲多癌種早期檢測的先驅,GRAIL不僅致力於評估Galleri測試的性能,還關注MCED篩查對患者的影響,」GRAIL的傑出科學家、該研究的共同作者Eric Klein博士表示。「收集參與者的觀點並適當支持癌症篩查的接受者可能會提高遵從率和早期檢測。PATHFINDER研究的患者報告結果顯示,MCED測試與高水平的滿意度相關。」

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.

關於GRAIL
GRAIL是一家醫療保健公司,旨在早期發現癌症,以便能夠治癒。GRAIL專注於通過利用下一代測序技術、群體規模的臨牀研究以及最先進的軟體、機器學習和自動化技術來減輕全球癌症負擔,從而在早期階段檢測和識別多種致命癌症類型。GRAIL的靶向甲基化平台可以支持篩查和精準腫瘤學的護理連續性,包括在有症狀患者中的多癌種早期檢測、風險分層、微小殘留病變檢測、生物標誌物亞型分析、治療和復發監測。GRAIL總部位於加州門洛帕克,在華盛頓特區、北卡羅來納州和英國設有辦事處。

For more information, visit grail.com.

如需更多信息,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多癌種早期檢測測試是一種主動的癌症篩查工具。只需簡單的抽血,Galleri測試就能識別癌細胞釋放的DNA,這可能成爲癌症的獨特「指紋」,有助於篩查一些今天沒有推薦篩查的致命癌症,例如胰腺癌、食道癌、卵巢癌、肝癌等。* Galleri測試可以在一個人出現症狀之前用於癌症篩查,此時癌症可能更容易治療,並且有可能治癒。Galleri測試可以指示癌症的來源,爲醫療提供者提供進一步探索的路線圖。Galleri測試需要持牌醫療提供者的處方,並應與推薦的癌症篩查一起使用,例如乳腺X光檢查、結腸鏡檢查、前列腺特異性抗原(PSA)測試或宮頸癌篩查。推薦對癌症風險較高的成年人使用Galleri測試,例如年齡在50歲或以上的人。

For more information, visit galleri.com.

如需更多信息,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 研究 參與者中 –
胰腺癌:總體敏感性83.7%(I期61.9%,II期60.0%,III期85.7%,IV期95.9%)。食道癌:總體敏感性85.0%(I期12.5%,II期64.7%,III期94.7%,IV期100%)。卵巢癌:總體敏感性83.1%(I期50.0%,II期80.0%,III期87.1%,IV期94.7%)。肝臟/膽管癌:總體敏感性93.5%(I期100%,II期70.0%,III期100%,IV期100%)。

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
Galleri檢測建議用於癌症風險較高的成年人,例如50歲或以上的人。Galleri檢測並不能檢測所有癌症,應作爲醫療服務提供者推薦的常規癌症篩查測試的補充。Galleri旨在檢測癌症信號並預測癌症信號在身體中的位置。不建議孕婦、21歲或以下的人或正在進行積極癌症治療的個體使用Galleri。

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.

結果應由醫療服務提供者在醫療歷史、臨牀跡象和症狀的背景下進行解釋。未檢測到癌症信號的測試結果並不能排除癌症。在檢測到癌症信號的測試結果需要通過醫學上確立的程序(例如影像學檢查)進行確認性診斷評估以確認癌症。

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.

如果通過進一步檢測未確認癌症,則可能意味着癌症不存在或檢測不足以檢測癌症,包括由於癌症位於身體的不同部位而造成的。假陽性(檢測到癌症信號時癌症並不存在)和假陰性(未檢測到癌症信號時癌症存在)測試結果是可能出現的。處方專用。

Laboratory/Test Information
The GRAIL 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 Food and Drug Administration. The GRAIL 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臨牀實驗室根據1988年臨牀實驗室改進修正案(CLIA)獲得認證,並得到美國病理學會的認可。Galleri測試是由GRAIL開發的,其性能特徵由GRAIL確定。Galleri測試尚未獲得美國食品藥品監督管理局的批准或許可。GRAIL臨牀實驗室在CLIA監管下進行高複雜度測試。Galleri測試旨在用於臨牀目的。

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 statements about extrapolation of data, expectations and projections of performance and impact of future tests or products, technology, clinical studies, regulatory compliance, future investment and strategy and anticipated trends in our business.

前瞻性聲明
本新聞稿包含前瞻性聲明。在某些情況下,您可以通過前瞻性詞彙如「目標」、「預計」、「相信」、「繼續」、「可能」、「估計」、「期待」、「打算」、「或許」、「計劃」、「潛在」、「預測」、「應」、「將」或「會」,以及這些術語的否定形式和其他可比術語來識別這些聲明。這些前瞻性聲明需要承擔風險、不確定性和我們的假設,可能包括關於數據推斷、未來測試或產品的性能和影響、科技、臨牀研究、監管合規、未來投資和策略以及我們業務的預期趨勢的陳述。

These statements are only predictions based on GRAIL's 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 GRAIL's most recent Quarterly Report on Form 10-Q filed with the SEC. Moreover, GRAIL operates in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for GRAIL's management to predict all risks, nor can they assess the impact of all factors on GRAIL's 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 GRAIL may make.

這些聲明只是基於GRAIL當前預期和對未來事件及趨勢的預測。 有一些重要因素可能導致我們的實際結果、活動水平、表現或成就與前瞻性聲明中表達或暗示的內容產生重大和不利的差異,包括在GRAIL最近提交給SEC的10-Q表格季度報告中討論的"風險因素"部分。此外,GRAIL在一個動態且快速變化的環境中運營。新的風險不時會出現。GRAIL的管理層無法預測所有風險,也無法評估所有因素對GRAIL業務的影響,或者任何單一因素或因素組合可能導致的實際結果、活動水平、表現或成就與GRAIL所做的任何前瞻性聲明中的內容產生重大且不利的差異。

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 GRAIL's control. Although GRAIL believes the expectations and projections expressed or implied by the forward-looking statements are reasonable, GRAIL cannot guarantee future results, level of activity, performance, or achievements. GRAIL's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, GRAIL undertakes no obligation to update any of these forward-looking statements after the date of this press release to conform its prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.

前瞻性陳述涉及未來,因此受到固有的不確定性、風險和變化的影響,這些因素很難預測,其中許多超出了GRAIL的控制範圍。儘管GRAIL認爲前瞻性陳述所表達或暗示的期望和預測是合理的,但GRAIL無法保證未來的結果、活動水平、表現或成就。GRAIL的實際結果和財務狀況可能與前瞻性陳述中所指示的有重大不同。除法律要求外,GRAIL沒有義務在本新聞稿日期之後更新任何這些前瞻性陳述,以使其先前的陳述符合實際結果或修訂後的期望,或反映新信息或意外事件的發生。

SOURCE GRAIL, Inc.

源公會,有限公司。

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