Business Wire

FDA Grants De Novo Designation for Adaptive Biotechnologies’ clonoSEQ Assay to Detect and Monitor Minimal Residual Disease (MRD) in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

Jaa

Adaptive Biotechnologies® announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance of clonoSEQ marks several “firsts” for patients and for the FDA. The clonoSEQ Assay represents a first-in-class MRD assay that uses next-generation sequencing (NGS) technology to assess disease burden, representing an important additional use of NGS in cancer. clonoSEQ is the first and only assay to be cleared by the FDA for MRD assessment in any lymphoid cancer and the first FDA-cleared diagnostic assay powered by immunosequencing. It is also a major milestone for Adaptive Biotechnologies as the first regulatory clearance for the company’s proprietary (NGS) platform for immune system profiling.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180928005655/en/

Detecting Minimal Residual Disease in MM and ALL (Graphic: Business Wire)

Detecting Minimal Residual Disease in MM and ALL (Graphic: Business Wire)

MRD refers to the small number of cancer cells that can remain in a patient’s body after treatment, which often cause no signs or symptoms but eventually can lead to recurrence of the disease. These residual cells can be present at very low levels and require highly sensitive tests to identify them. Even very small amounts of MRD can have a profound effect on treatment success and patient outcomes. A test that can reliably determine the presence and amount of residual disease at very low levels can be used by physicians in conjunction with other clinical information to predict treatment outcomes, guide management decisions and improve patient care.

“MRD testing provides patients with real-time insights about their response to therapy or the depth of their remission, therefore the MMRF is deeply committed to this important advancement in patient care,” said Paul Giusti, president and chief executive officer, Multiple Myeloma Research Foundation (MMRF). “The sensitivity of the test is extremely important, as the number of cells remaining after treatment has been linked to patient outcomes. This clearance provides patients and physicians with access to a highly sensitive, standardized MRD test that can be an important tool in guiding treatment decisions.”

There are more than 200,000 MM and ALL patients living in the U.S., and more than 35,000 new cases are diagnosed each year. The clonoSEQ Assay uses NGS to precisely identify and monitor MRD in these patients throughout treatment and remission, with greater sensitivity than other technologies for any given amount of bone marrow sample.1 Detecting MRD with deep sensitivity can be clinically informative for the many patients being treated for these cancers.

“The FDA clearance of clonoSEQ is an important advance for patients with MM and ALL and for the oncologists who care for them. This milestone underscores the importance of MRD as a predictor of patient outcomes,” said Aaron Logan, associate professor, Division of Hematology and Blood and Marrow Transplant, UCSF. “Quantification of MRD should be standard practice to assess response to treatment, monitor disease progression and direct patient care. It is thus essential to have an MRD assay that meets regulatory standards and can accurately and reliably measure and track disease burden over time.”

For patients who achieve complete response to cancer treatment by traditional response criteria, the presence or absence of MRD has been demonstrated to have a significant relationship with patient outcomes.2 For this reason, many pharmaceutical companies have begun using MRD as a clinically meaningful endpoint to evaluate efficacy and to guide use of their therapies.

“This year has been historic for the field of hematology, with a paradigm-shifting FDA decision to approve the first therapy, BLINCYTO, based on the MRD status of a patient with ALL, validating the clinical relevance of MRD in ALL as a clinically meaningful endpoint,” said Greg Friberg, M.D., vice president, Global Development, Oncology at Amgen. “Now, physicians and patients will have access to the first FDA-cleared MRD assay, providing them with another important tool to make informed decisions about treatments to help achieve MRD negativity. We look forward to continuing our collaboration with Adaptive Biotechnologies to further explore MRD and deliver on our mission to serve patients through transformative science.”

The recent FDA review and approval of drugs with MRD included as a clinical endpoint, as well as the agency’s inclusion of MRD on the recently released list of surrogate endpoints that can serve as the basis of drug approvals, demonstrate the clinical actionability of MRD and reinforce the need for an accurate and standardized, FDA-cleared method like clonoSEQ.3,4

“The clearance of the clonoSEQ Assay is an exciting advance for MM and ALL patients and physicians; as MRD is increasingly used to inform treatment decisions, the importance of having an accurate and standardized assessment method becomes paramount,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “NGS MRD testing is already part of National Comprehensive Cancer Network (NCCN) treatment guidelines for patients with MM, ALL, and CLL, and clonoSEQ is already in use for patient management in the majority of NCCN cancer centers, further demonstrating the clinical importance of MRD and acceptance of NGS MRD testing by the oncology community. Adaptive is working diligently with public and private payers to make clonoSEQ broadly available to patients in need.”

About Minimal Residual Disease

Minimal residual disease (MRD), also referred to as measurable residual disease, refers to cancer cells that remain in the body after treatment for patients with lymphoid cancers. These cells can be present at levels undetectable by traditional morphologic methods, microscopic examination of blood, or a bone marrow or a lymph node biopsy.

MRD is used by physicians to detect and monitor disease burden in patients and to inform their treatment decisions. Clinical practice guidelines recommend assessing MRD at multiple time points during treatment and maintenance in MM and ALL, and guidelines for both diseases include NGS as a recommended testing method.5,6 The prognostic value of MRD assessment has been demonstrated in multiple lymphoid cancers.7,8 Controlled trials have shown that even small amounts of disease are profoundly significant for predicting a patient’s long-term clinical outcomes.1,9,10,11,12 Therefore, highly sensitive, standardized molecular technologies are needed for reliable detection of MRD.

Measurement of MRD is currently being evaluated as a way to measure efficacy in drug trials, with the potential to expedite the approval of emerging therapies.13

About the clonoSEQ ®  Assay

The Adaptive Biotechnologies clonoSEQ Assay has been granted De Novo designation by the FDA as an in vitro diagnostic (IVD) to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. It identifies and quantifies specific DNA sequences found in malignant cells, allowing clinicians to monitor patients for changes in disease burden during and after treatment. This robust assay provides sensitive and accurate measurement of residual disease that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers.

clonoSEQ was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.

About Adaptive Biotechnologies

Adaptive Biotechnologies is the pioneer and leader in combining next-generation sequencing (NGS) and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immunosequencing platform to researchers and clinicians around the world to drive groundbreaking research in cancer and other immune-mediated diseases. Adaptive also translates immunosequencing discoveries into clinical diagnostics and therapeutic development to improve patient care. For more information, please visit adaptivebiotech.com.

Adaptive Biotechnologies does not endorse the use of any particular therapy.

1 Perrot A, et al. Blood. 2018:blood-2018-06-858613.

2 Martinez-Lopez J, et al. Blood. 2014;123(20):3073-9.

3 BLINCYTO (blinatumomab) Full Prescribing Information. Retrieved September 26, 2018 from: https://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.pdf

4 DARZALEX (daratumumab) Full Prescribing Information. Retrieved September 26, 2018 from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf

5 NCCN Clinical Practice Guidelines in Oncology for Multiple Myeloma. V.3.2018.

6 NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia. Version 1.2018.

7 Wu, D, et al. Clin Cancer Res. 201:20(17):4540-9.

8 Korde N, et al. JAMA Oncol. 2015:1(6):746-54.

9 Dimopoulos MA, et al. N Engl J Med. 2016;375:1319-1331.

10 Pulsipher M, et al. Blood. 2015;125(22):3501-8. Adaptive Biotechnologies provided financial support for this study.

11 Mannis GN, et al. Biol Blood Marrow Transplant. 2016;22:1030-1036. Adaptive Biotechnologies provided financial support for this study.

12 Logan AC, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-13. Adaptive Biotechnologies provided financial support for this study. Clinician has received compensation to participate in advisory meetings sponsored by Adaptive.

13 Avet-Loiseau H. Am Soc Clin Oncol Educ Book. 2016; 35e425-30.

Contact information

Adaptive Biotechnologies
Beth Keshishian, 917-912-7195
media@adaptivebiotech.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Blue Danube Systems Enhances BeamPlanner™ Software Including Artificial Intelligence and Machine Learning Capabilities21.2.2019 23:00:00Tiedote

Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing new capabilities into its BeamPlanner™ cloud software suite. BeamPlanner is the world’s first network planning and optimization tool for beamforming antenna systems. With the new and enhanced artificial intelligence (AI) and machine learning (ML) functionalities, BeamPlanner becomes the automated platform for network-wide operation of Blue Danube’s Coherent Massive MIMO systems. BeamPlanner utilizes an intelligent analytics-based, data-driven multi-site optimization engine that now has been enhanced with 3D ray tracing capabilities for improved prediction results accuracy. The simulation platform provides actionable beamforming recommendations and expected capacity results matching the real-world performance results validated through drive tests, network statistics data and standard key performance indicators (KPIs). In

Recipients of HCL GRANT 2019 Felicitated by Amitabh Kant & Sourav Ganguly21.2.2019 22:06:00Tiedote

Mr. Amitabh Kant, CEO, Niti Aayog and Mr. Sourav Ganguly, Former captain of the Indian National Cricket Team felicitated the winners of HCL Grant 2019 at a ceremony held today at HCL Technologies Campus, Noida, in the presence of Mr. Shiv Nadar, Founder & Chairman, HCL, Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies, along with senior dignitaries, bureaucrats, NGO-partners and the HCL leadership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005822/en/ L to R - Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies; Mr. Sourav Ganguly, Former Captain of Indian National Cricket Team; Mr. Amitabh Kant, CEO, NITI Aayog and Ms. Robin Abrams, former president of Palm Computing and longest-serving Board member of HCL Technologies along with the HCL Grant 2019 recipients - Environment - Wildlife Trust of In

International Indigenous Languages Conference Set for June in British Columbia21.2.2019 20:48:00Tiedote

In celebration of the United Nations 2019 International Year of Indigenous Languages, the First Peoples’ Cultural Foundation (FPCF) and the First Peoples’ Cultural Council (FPCC), in partnership with the Canadian Commission for UNESCO, will host a major international conference on Indigenous language revitalization in British Columbia this summer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005758/en/ WHAT: The HELISET TŦE SḰÁL – ‘Let the Languages Live’ – 2019 International Conference on Indigenous Languages will bring together Indigenous leaders and language experts, speakers, learners and advocates from around the globe to celebrate, honour and share expertise in Indigenous language reclamation, revitalization and maintenance and to learn about successful language projects in B.C. The goal of the conference is to provide participants with practical skills and knowledge to support the Indigenous language revitaliz

Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot21.2.2019 20:00:00Tiedote

Axilum Robotics, specializing in the development of medical robots, announces that, 2 weeks after the CE mark, the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005667/en/ Axilum Robotics TMS-Cobot (Photo: Business Wire) After having successfully developed and launched outside of the United States (OUS) the TMS-Robot, the first robot designed to assist health care professionals in delivering Transcranial Magnetic Stimulation (TMS), based on an invention of ICube laboratory in Strasbourg, Axilum Robotics has reinforced its expertise in medical robotics with the development of a new platform based on collaborative robot technology. TMS-Cobot, the first medical device built on this platform, allows

myPOS Presented with Best POS Innovation Award by the Merchant Payment Ecosystem21.2.2019 17:57:00Tiedote

myPOS, one of the fastest growing European payment providers was handed the Best POS Innovation/POS Software Payment Applications award for 2019 by the Merchant Payment Ecosystem (MPE) at a Gala Dinner ceremony in Berlin last night. Being known for offering instant settlement and no-monthly-fees model to SMEs across Europe, myPOS provides a range of innovative features on its payment devices, some of which include Tipping, Payment Request, Top-up and GiftCards. In addition, myPOS merchants are entitled to a whole range of subscription-free, value-added services such as Virtual MO/TO, PayLinks and PayButtons, Checkout module with the most popular shopping carts and more. myPOS clients are also given the opportunity to manage their funds with a free online account and a unique banking platform. The company got nominated in two categories: Best POS Innovation and Best Acquirer of the year, but ultimately won the Best POS Innovation award. "We accept this award with gratitude and appreciat

New Release Crea Records: "ABBA We Love You Forever"21.2.2019 17:44:00Tiedote

Not many people on this earth can say that they have never heard of ABBA. In addition to the wonderful voices of Agnetha Fältskog and Anni-Fried Lyngstad, the musicians, Björn Ulvaeus and Benny Andersson have written the most wonderful songs, not only composed with charm and elegance, but also so breathtakingly beautiful and unforgettable that they will always resonate. For the Danish singer, BILLBOARD Hot 100 artist, composer and lyricist, Lecia Jonsson, ABBA has been much more than an inspiration. Lecia shared the same melodic universe as ABBA, making her mark with many records as part of duo LECIA & LUCIENNE. Later, as part of another duo, LABAN, Lecia entered BILLBOARD HOT 100 in the United States, had releases in 48 countries worldwide, and sold more than 1.5 million albums. Lecia’s identity is formed by her pure voice and her great sense for writing unique songs filled with a great melodic substance. If anyone should write a song to honour ABBA’s music, Lecia is definitely the pe

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme