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Semaphore Helps Adaptive Biotechnologies Meet Milestones

Discover how Semaphore can help Adaptive Technologies avoid risk and meet key timelines

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Client Overview

Adaptive Biotechnologies, based in Seattle, WA, is a pioneer and leader in immune-driven medicine that aims to improve people’s lives by learning from the wisdom of their adaptive immune systems. Adaptive’s Immune Medicine Platform reveals and translates insights from the human adaptive immune systems with unprecedented scale and precision. Working with drug developers, clinicians, and academic researchers, Adaptive is applying these insights to develop products that will transform diseases such as cancer, autoimmune conditions, and infectious diseases.

CHALLENGES

For a rapidly growing company like Adaptive Biotechnologies, maintaining and improving critical software systems are top priorities, which requires the right team with the right experience.

Solution Overview

Custom Software Powers Modern Laboratories

Adaptive has developed a comprehensive suite of custom software solutions to support their complex laboratory business. Their software team is also responsible for an implementation of Clarity LIMS, an off-the-shelf system that manages wet lab workflows. Adaptive has a mature software development organization with an advanced Agile practice suitable for their feature release and compliance milestone cadence. They must ensure that all software instances, whether fully custom or COTS, are validated according to various regulatory environments including CAP, CLIA, and the FDA. Adaptive requires a team of experienced and qualified developers capable of executing the software engineering roadmap of a complex NGS laboratory.

Maintaining the Right Sized Technical Team

Adaptive requires individuals with experience in regulated software development environments. This includes software team members that not only have strong programming experience, but also can adopt established process and integrate with a fast-paced team. New business goals and new regulatory requirements can sometimes lead to an urgent need for technical resources to work on the critical software systems.

Scaling the Diagnostic Business

Increased sample throughput requires software that evolves to support higher laboratory efficiency. This results in a new test development pipeline to include assays with complex software needs. New tests also increase the load of regulatory compliance activities that must be supported by software systems.

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Key Outcomes and Measurable Results

Regulatory Approvals

Adaptive Biotechnologies celebrated multiple successes in 2018-2019, including the FDA De Novo designation for their clonoSEQ Assay which detects and monitors 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. Furthermore, Adaptive also received Medicare coverage for the clonoSEQ Assay, which supports their work to obtain coverage for eligible patients in need.

Key Milestones Met

Adaptive was able to meet software development milestones during a time of increased load due to FDA clearance, and continues to scale laboratory infrastructure to meet the demands of innovative new test development and increased in sample throughput.

Key Outcomes and Measurable Results

Regulatory Approvals

Adaptive Biotechnologies celebrated multiple successes in 2018-2019, including the FDA De Novo designation for their clonoSEQ Assay which detects and monitors 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. Furthermore, Adaptive also received Medicare coverage for the clonoSEQ Assay, which supports their work to obtain coverage for eligible patients in need.

Key Milestones Met

Adaptive was able to meet software development milestones during a time of increased load due to FDA clearance, and continues to scale laboratory infrastructure to meet the demands of innovative new test development and increased in sample throughput.

“Using software to differentiate our business has been part of Adaptive’s strategy since its inception. We don’t do a lot of outsourcing, but our relationship with Semaphore has been instrumental to our success. They help us scale up quickly when needed, and their experience with Clarity and NGS lab process is a key resource we use regularly.”
Sean Nolan, Chief Technology Officer, Adaptive Biotechnologies

In-Depth Analysis

During times of growth, laboratory businesses need a trusted partner that provides domain-specific software staffing solutions appropriate to their goals. Adaptive’s engagement with Semaphore includes a specialized solution for their growing business.

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Expert Laboratory Software Staffing: Semaphore’s full-stack software engineers, experienced in the NGS clinical diagnostic domain, are high contributors on Adaptive’s internal software team.

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Pool of Experts: Adaptive benefits from Semaphore’s collective knowledge of NGS clinical diagnostic laboratories and custom software solutions. When complex challenges arise, Adaptive technical staff are able to draw upon Semaphore’s pool of software experts to provide additional software architecture and laboratory workflow consulting as needed.

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Software Development Practices: Semaphore’s technical team is committed to software engineering practices that lead to high-quality software. Our experienced developers fully participate in Adaptive’s well-established software methodology and quality practice.

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Quick Ramp Up: Semaphore’s team members quickly and efficiently integrate into Adaptive’s software organization due to Semaphore’s extensive experience developing software for clinical diagnostic laboratories.

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Flexible Staffing Arrangements: Successfully managing the software systems for a dynamic laboratory business requires a partner that can respond to an evolving development plan. Semaphore continually works with Adaptive management to help meet business goals in a fast-changing landscape.

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Why it Matters

With the support of Semaphore’s expert software staff solutions, Adaptive is able to navigate the clinical diagnostics market with minimal risk due to variable demand in their software roadmap.

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