Adaptive Biotechnologies Announces Over 65 Abstracts Featuring ClonoSEQ MRD Testing Across a Range of Blood Cancers to Be Presented at the 66th ASH Annual Meeting
Adaptive Biotechnologies Announces Over 65 Abstracts Featuring ClonoSEQ MRD Testing Across a Range of Blood Cancers to Be Presented at the 66th ASH Annual Meeting
SEATTLE, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced that its next-generation sequencing (NGS)-based clonoSEQ test for measurable residual disease (MRD) assessment will be included in more than 65 abstracts across eight different types of blood cancer at the 66th Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2024, in San Diego. Among these abstracts are a plenary session presentation, a late-breaking abstract and 25 other oral presentations.
西雅圖,2024年12月03日(全球新聞通訊)-- adaptive biotechnologies 公司(納斯達克:ADPT)是一家商業階段的生物技術公司,旨在將適應性免疫系統的遺傳學轉化爲臨床產品,以診斷和治療疾病。該公司宣佈,其基於下一代測序(NGS)的 clonoSEQ 測試將用於評估可測量的殘留病(MRD),將在2024年12月7日至10日於聖地亞哥舉行的第66屆美國血液學會(ASH)年會上包含在65篇以上的摘要中。這些摘要中包括一次全體會議報告,一篇最新的摘要和25個其他的口頭報告。
"We are inspired to see clonoSEQ MRD testing featured in a record-breaking number of studies at this year's ASH Annual Meeting," said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. "The increasingly widespread use of clonoSEQ as a highly sensitive test to support clinical decision-making and as a primary endpoint in clinical trials highlights its multi-faceted role in advancing precision medicine in hematology."
「我們受到啓發,看到 clonoSEQ MRD 測試在今年的 ASH 年會上以創紀錄的數量被特色板塊展示,」adaptive biotechnologies 的首席商業官、MRD 負責人蘇珊·博布爾斯基說道。「clonoSEQ 作爲一種高靈敏度測試在臨床決策中越來越廣泛的應用,以及作爲臨床試驗的主要控件,突顯了它在推進血液學精準醫療中的多方面作用。」
Multiple studies underscore the use of clonoSEQ as the standard for demonstrating efficacy in pivotal clinical trials and highlight advantages of leveraging the highest sensitivity in both clinical trials and real-world practice across various blood cancers. Notably, several practice-changing studies using MRD as a primary endpoint in multiple myeloma (MM), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL), as well as studies using MRD interventionally in acute lymphoblastic leukemia (ALL), MM, MCL, and CLL, further validate its critical role in assessing deep therapeutic responses and informing treatment decisions.
多項研究強調了將 clonoSEQ 作爲在關鍵臨床試驗中證明療效的標準,並突出了在各種血液腫瘤中利用最高靈敏度的臨床試驗和現實實踐的優勢。值得注意的是,多個以 MRD 作爲主要控件的實踐改變研究在多發性骨髓瘤(MM)、披衣細胞淋巴瘤(MCL)和慢性淋巴細胞白血病(CLL)中,及在急性淋巴細胞白血病(ALL)、MM、MCL 和 CLL 中進行的 MRD 介入研究進一步確認了其在評估深度治療反應和指導治療決策中的關鍵作用。
A complete list of the accepted abstracts featuring clonoSEQ is available here.
有關包含 clonoSEQ 的所有接受的摘要的完整列表可用 這裏.
About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ is CE-marked under IVDR in the EU. For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request.
關於clonoSEQ
clonoSEQ是首個也是唯一一個獲得FDA批准的體外診斷(IVD)測試,旨在檢測多發性骨髓瘤(MM)或b型急性淋巴細胞白血病(b-ALL)患者的骨髓中的最小殘留疾病(MRD),以及慢性淋巴細胞白血病(CLL)患者的血液或骨髓。clonoSEQ目前可作爲實驗室開發測試(LDT)在實施於adaptive biotechnologies在華盛頓州西雅圖的CLIA認證實驗室中,對瀰漫大B細胞淋巴瘤(DLBCL)和套細胞淋巴瘤(MCL)患者進行檢測。clonoSEQ在歐盟根據IVDR進行了CE標記。有關IVDR下在歐盟批准的預期用途,請參閱可按要求提供的使用說明。
clonoSEQ leverages Adaptive Biotechnologies' proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The test provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ in patients diagnosed with CLL, MM, ALL and DLBCL.
clonoSEQ利用adaptive biotechnologies的專有免疫醫學平台來識別和定量惡性細胞中的特定DNA序列,使臨床醫生能夠在治療期間及之後評估和監測MRD。該測試提供標準化、準確和敏感的MRD測量,允許醫生預測患者的結果,評估治療反應,告知治療更改,監測疾病負擔隨時間的變化,並早期檢測潛在的復發。血液惡性腫瘤的臨床實踐指南認可MRD狀態是臨床結果和治療反應的可靠指標,並且臨床結果已被證明與通過clonoSEQ測量的患者MRD水平之間存在強關聯,患者診斷爲CLL、MM、ALL及DLBCL。
For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit .
有關clonoSEQ獲得FDA批准的用途的重要信息,包括完整的預期用途,限制條件和詳細的性能特徵,請訪問 .
About Adaptive Biotechnologies
Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
關於Adaptive Biotechnologies
Adaptive Biotechnologies(「我們」或「我們的」)是一家商業化生物技術公司,專注於利用適應性免疫系統的固有生物學,改變疾病的診斷和治療。我們認爲,適應性免疫系統是自然界中用於大多數疾病的最精細調節的診斷和治療方法,但無法對其進行 解碼阻止了醫學界充分利用其能力。我們專利的免疫藥物平台可以大規模、精確、迅速地揭示並翻譯適應性免疫系統的巨大遺傳信息。我們將這種方法應用於與生物製藥公司的合作中,以推動藥物的研發和臨床診斷。我們的商業產品和臨床管道使癌症、自身免疫性疾病和傳染性疾病等疾病的診斷、監測和治療成爲可能。我們的目標是開發和商業化針對每個病人量身定製的免疫驅動的臨床產品。
Forward Looking Statements
This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.
前瞻性聲明
本新聞發佈包含基於管理層信念和假設以及目前可獲得的信息的前瞻性陳述。 本發佈中包含的所有陳述(除歷史事實陳述外)都是前瞻性陳述,包括關於我們開發、商業化及實現市場接受我們當前及計劃產品和服務的能力、我們的研發工作以及其他與我們的業務戰略、資本使用、運營結果和財務狀況,以及未來運營的計劃和目標相關的事項的陳述。
In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
在某些情況下,您可以通過諸如「可能」、「將」、「能夠」、「會」、「應該」、「期望」、「打算」、「計劃」、「預期」、「相信」、「估計」、「預測」、「項目」、「潛在」、「繼續」、「正在進行的」或這些術語的否定形式或其他類似術語來識別前瞻性聲明,儘管並非所有的前瞻性聲明都包含這些詞。這些聲明涉及風險、不確定性和其他因素,可能導致實際結果、活動水平、表現或成就與前瞻性聲明所表達或暗示的信息大相徑庭。這些風險、不確定性和其他因素在我們不時向證券交易委員會提交的文件中的「風險因素」、「管理層的財務狀況與運營結果的討論與分析」以及其他地方進行了描述。我們提醒您,前瞻性聲明是基於我們當前已知的事實和因素的組合以及我們對未來的預測,而我們對此不能確定。因此,前瞻性聲明可能不能被證明是準確的。本新聞稿中的前瞻性聲明代表了我們截至本日期的觀點。我們沒有義務出於任何原因更新任何前瞻性聲明,除非法律要求。
ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
investors@adaptivebiotech.com
ADAPTIVE INVESTORS
投資者關係副總裁Karina Calzadilla
201-396-1687
investors@adaptivebiotech.com
ADAPTIVE MEDIA
Erica Jones, Associate Director, Corporate Communications
206-279-2423
media@adaptivebiotech.com
ADAPTIVE MEDIA
企業傳媒副總裁Erica Jones
206-279-2423
media@adaptivebiotech.com