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

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

IFF Recognized by SAM’s 2019 “Industry Mover” Sustainability Award15.2.2019 21:15:00Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), was recognized for its sustainability efforts with the 2019 “Industry Mover” award from SAM, a subsidiary of RobecoSAM which specializes in providing environmental, social and governance (ESG) data, benchmarks and ratings. The recognition acknowledges the Company’s top-scoring performance in economic, social and environmental categories. “We are thrilled to receive this award from SAM,” said Andreas Fibig, IFF Chairman & CEO. “Our sustainability efforts are not only a key enabler of our overall strategy, but also a true passion here at IFF -- and we place it at the forefront of everything we do. It is deeply gratifying to have our work and our people recognized for doing the right thing for the planet.” SAM’s 2019 scoring is based on its 2018 Corporate Sustainability Assessment. Using a weighted methodology, SAM evaluates companies for criteria such as: codes of business conduct, ope

SFL: strong financial position and results in 2018, consolidating the Group’s position as a prime player15.2.2019 18:01:00Pressemelding

Regulatory News: The financial statements for the year ended 31 December 2018 were approved by the Board of Directors of Société Foncière Lyonnaise (Paris:FLY) on 15 February 2019 at a meeting chaired by Juan José Brugera. 2018 business indicators were very robust, with further underlying growth in rental income and historically high EPRA earnings. The portfolio's appraisal value and the Company's net asset value also continued to grow, attesting to SFL’s excellent positioning. The auditors have completed their audit of the annual financial information and are in the process of issuing their report. Consolidated data (€ millions) 2018 2017 Change Rental income 193.5 195.8 -1.2% Adjusted operating profit* 162.1 164.1 -1.2% Attributable net profit 351.6 685.3 - EPRA earnings 106.7 102.4 +4.1% * Operating profit before disposal gains and losses and fair value adjustments 31/12/2018 31/12/2017 Change Attributable equity 4,010 3,763 +6.6% Consolidated portfolio value excluding transfer cost

5 Happening Cultural Destinations to Visit in 201915.2.2019 10:11:00Pressemelding

Hong Kong There’s never really a sleepy year to visit Hong Kong, but 2019 is particularly ripe for visitors. Spearheaded by the dynamic entrepreneur Adrian Cheng of K11 and New World Development, the rejuvenation of Tsim Sha Tsui harbourfront is just the starting point. The city’s iconic harbourside walkway, Avenue of Stars, has just received a much-awaited makeover that’s the brainchild of Cheng and visually conceived by James Corner, the landscape architect responsible for the High Line in New York. It sees the addition of design-driven rest areas, kiosks featuring homegrown brands, hand prints from Asian film stars and interactive digital elements. Featuring Hong Kong’s first wave energy demonstrator that produces electricity for the Avenue, the place is turned into one of the most sustainable promenades in Hong Kong. This is just one part of Cheng and his company’s grander urban revitalisation plan, Victoria Dockside, a new art and design district which will fully open in the third

ISAE-SUPAERO Launches a New MOOC about Flight Mechanics15.2.2019 09:36:00Pressemelding

"ABC of Flight Mechanics: How Do Planes Fly?": a MOOC dedicated to flight mechanics. The notion of flight often defies our human terrestrial instincts. How does an airplane fly? How can a pilot maintain control? How high in the sky can an aircraft climb? How does a fighter pilot fly while spinning? This online course (available in English) will cover many topics, such as atmospheric physics and Newton's laws applied to aircraft, as well as propulsion forces and longitudinal stability the question of traction. The MOOC "ABC of Flight Mechanics" is aimed at general public with a specific level of scientific knowledge. Nevertheless, various levels of learning are available, thus it allows all students to take the course without needing to plenty understand the mathematical principles. Undergraduate students in aerospace engineering, trainees as well as novice and experienced pilots, journalists and professionals in the aeronautics domain (business, engineering, marketing, communications,

REPLY: Red Reply Wins the Oracle “Partner of the Year Autonomous” Award15.2.2019 09:30:00Pressemelding

Red Reply, the Reply group company that specialises in the Oracle Cloud IaaS and PaaS platform has been named as Oracle “Partner of the Year: Autonomous.” The award recognises Red Reply for its work as an Oracle Cloud Managed Service Provider Partner in developing highly innovative projects using the Oracle Autonomous Database technology. Red Reply has launched a project aimed at re-engineering the Policy Enterprise DataWarehouse of Verti Assicurazioni, company operating in the online insurance sector, using the Oracle Cloud Autonomous DataWarehouse service. The Autonomous DataWarehouse is a cloud-based database that uses machine learning to eliminate manual labour in operations such as tuning, security, backups, updates and other routine activities. This selected Oracle solution is the only one of its kind capable of addressing aspects such as security, performance and high availability of data, using automatic update and tuning mechanisms, while maximising the protection of data in l

Posiflex showcases new Interactive Self-Service Kiosks and IoT Retail Product Innovations at EuroCIS 201915.2.2019 08:00:00Pressemelding

The Posiflex Group — a synergy of world-leading POS, kiosk, and industrial computing technologies — will introduce its full product portfolio and latest innovations at EuroCIS, the leading trade fair for retail technology, from February 19th – 21st in Düsseldorf. With a product strategy focus on serviced IoT, the Posiflex Group will be displaying smart and connected retail solutions with fully-integrated middleware, RMS (Remote Monitoring System) and hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190215005008/en/ Posiflex at EuroCIS Hall 9 / C42 (Graphic: Business Wire) “I am excited to introduce the Posiflex Group portfolio to the European market,” says Hans Peter Nüdling, the newly appointed Chief Strategy Officer for the Posiflex Group. “The Posiflex Group references the collective brands of the corporation, including Posiflex, Portwell and KIOSK Information Systems (KIOSK) – all under one corporate umbrella. As