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Adaptive Bio Plans New NGS-based Immune Profiling Tests; RUO ImmunoSeq Kit to Launch This Year

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Adaptive Biotechnologies is aiming to develop new next-gen sequencing-based immune profiling tests over the next two years and plans to begin marketing its proprietary ImmunoSeq technology as a research-use only kit in the second half of the year, the company said last week at the JP Morgan Healthcare Conference in San Francisco.

Adaptive Bio, a Fred Hutchinson Cancer Research Center spinout, launched its first clinical test last year out of its CLIA-certified laboratory in Seattle. ClonoSeq assesses minimal residual disease in leukemia and lymphoma patients by targeting the CDR3 regions of T cell and B cell receptors. Adaptive uses a proprietary multiplex PCR technology coupled with next-gen sequencing on Illumina's HiSeq 2500 or MiSeq.

CEO Chad Robins told Clinical Sequencing News that the firm is also considering purchasing Illumina's cleared MiSeqDx system. "There's a huge demand from pathology labs to have a [US Food and Drug Administration cleared] MRD product using next-gen sequencing," he said.

Turnaround time for the test is seven days. Adaptive Bio bills the prescribing institution $500 for the diagnostic test, which measures clonality, and $850 for a monitoring test. Robins said that the firm had not yet collected enough data on reimbursement to say whether payors are regularly covering the test and for how much.

Aside from its clinical test, Adaptive Bio provides immune sequencing services via its ImmunoSeq research assay. The firm currently is working with more than 350 academic customers and around 20 pharmaceutical clients. Academic customers use Adaptive's services to characterize the immune repertoire, identify public T cells, and to track clones, Robins said during a presentation at the JP Morgan conference. Its pharmaceutical clients use Adaptive's services for things like monitoring patients' response to therapy and identifying maximum tolerated dose of drugs.

Its pharmaceutical partnerships include Bristol Myers Squibb, MedImmune, and Johnson & Johnson. Recently, it inked a biomarker discovery agreement with Janssen Research & Development to identify patients more likely to respond to immunology and oncology drugs being developed by Janssen.

By the end of this year, the company plans to market ImmunoSeq as a research use-only kit, rather than just offering it as a service. Similar to its ClonoSeq test, ImmunoSeq uses multiplex PCR and next-gen sequencing to analyze the CDR3 region. According to Robins, the company has a patent pending on methodology to control amplification bias from its multiplex PCR step.

Additionally, even though researchers will be able to purchase a kit version of ImmunoSeq, Robins said that all the data generated from laboratories running ImmunoSeq will be sent back to Adaptive Bio through its data analysis portal. From there, the data is uploaded to the firm's cloud-based ImmunoSeq Analyzer. Users can log on to the ImmunoSeq Analyzer to view, access, analyze, and share their data.

Robins said that the research market for immune profiling in blood-based cancers would reach $390 million by 2018, including work with academic researchers, pharmaceutical companies, and clinical trials. Meantime, the diagnostic market for immune profiling in blood-based cancers and in solid tumors is projected to reach $850 million by 2018, he said.

To expand its reach into immune profiling in solid tumors, Adaptive Bio next year plans to launch its second clinical product, QuanTILfy. The test will assess tumor-infiltrating lymphocytes in solid tumors, targeting and sequencing the CDR3 region of TILs. Initially, the test will be designed to assess the number and clonality of TILs to enable more accurate staging. Robins said that the assay is currently being validated in ovarian and colorectal cancer. By the end of 2015, the firm plans to validate QuanTILfy for a second purpose — determining how patients respond to immunotherapy.

Aside from oncology, Adaptive Bio is also tackling transplantation and in 2016 is aiming to launch a test that determines the health of a patient's immune system post-transplantation.

"There is a diverse repertoire of cells that make up the immune system and after transplantation, the immune system has to reconstitute," Robins said. "You have to have a diversity of clones to fight infection." Studies have found that patients who do not redevelop their immune cell diversity after a couple of months are more likely to die from infection, he said.

Adaptive Bio plans to develop a test that can accurately assess immune system reconstitution, which could help physicians make decisions about whether a patient needs higher doses of medication to keep infection at bay, or whether their therapy can be reduced.

Along those lines, the company recently secured a $2.53 million Phase II Small Business Innovation Research Grant from the National Institutes of Health to support development of such a test for cancer patients that receive a cord blood transplant. Under the grant, the company will conduct a prospective phase II study over a three-year period on approximately 400 cord blood transplant recipients from five transplant centers at Harvard University, Dana-Farber Cancer Institute, Johns Hopkins University, the Fred Hutchinson Cancer Center, and Duke University.

Looking ahead, Robins said while Adaptive's initial focus is in oncology, the technology could be applied to "anything related to the immune system," such as autoimmune diseases, infectious disease, and vaccines.

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