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LISA brings together industry leaders and experts to support CAP and COLA-accredited diagnostic laboratories.
Our association includes key industry players such as Argonaut Manufacturing Services, Arete Biosciences, SeqOnce Biosciences, PCRassays.com, and BlazedX, each bringing specialized expertise in manufacturing, regulatory affairs, technical assessments, and laboratory support.
Argonaut Manufacturing Services is a leader in quality control testing and cGMP manufacturing. They bring extensive expertise in supply chain management and fulfillment, ensuring that all reagents and assay components meet the highest standards of quality and regulatory compliance. Argonaut’s role in LISA is crucial to produce cGMP reagents, required in FDA Phase 3 and beyond.
Arete Biosciences excels in navigating FDA communications and regulatory requirements. They manage the entire 510(k)/PMA process, from pre-submission to final approval, and oversee both analytical and clinical testing. With a deep understanding of the regulatory landscape, Arete ensures that all assays meet stringent FDA standards, providing essential guidance throughout the submission process.
SeqOnce Biosciences brings innovative qPCR assay technology and expertise to the consortium. They are responsible for the technical assessment and documentation of assays, as well as the transfer of this documentation to manufacturing. SeqOnce’s role is pivotal in ensuring that assays are technically sound and ready for regulatory submission.
BlazedX provides technical support for LISA products and its members, including field application specialists. BlazedX is responsible for organizing the consortium, communicating with lab members, and providing essential training and technical assistance. BlazedX’s role is integral to maintaining a cohesive and informed association, ensuring that all members are aligned and well-supported.
PCRassays.com specializes in multiplexed assay design and development using their exclusive access to the tools from DNA Software, Inc. With over 23 years of experience serving the leaders in molecular testing, they are responsible for probe and primer design, multiplex compatibility, in-silico inclusivity, exclusivity, and cross-reactivity analysis, assay optimization and formulation, and engineering batches. PCRassay.com’s role in LISA is to ensure the highest standard of assay performance.
Epstein Becker & Green, P.C., a national law firm, provides legal counsel to LISA with respect to FDA, CLIA, health regulatory and antitrust issues. With a team of diverse attorneys and professionals, they focus their resources on health care, life sciences, and workforce management solutions, coupled with powerful litigation strategies.
Joining LISA offers your lab a strategic advantage in navigating the complex regulatory landscape introduced by the FDA’s oversight of LDTs.
By becoming a member, you gain access to expert guidance, new assays, and shared financial resources, enabling your lab to maintain compliance without the overwhelming burden of going it alone.
LISA’s collaborative and innovative crowd-funding model ensures that your lab can continue to develop and implement new assays efficiently and cost-effectively, securing your place at the forefront of diagnostic testing.
Together, we can shape the future of diagnostic testing. Welcome to LISA.