BioCompute Object

<p>The BioCompute Object (BCO) project is a community-driven initiative to build a framework for standardizing and sharing computations and analyses generated from <a href="/facts/High-throughput_sequencing/hsPsNCQW">High-throughput sequencing</a> (HTS—also referred to as <a href="/facts/Next-generation_sequencing/FjLl8GGa">next-generation sequencing</a> or <a href="/facts/Massively_parallel_sequencing/FjLl8GGa">massively parallel sequencing</a>). The project has since been <a href="https://standards.ieee.org/ieee/2791/7337/">standardized</a> as IEEE 2791-2020, and the project files are maintained in an <a href="https://opensource.ieee.org/2791-object/ieee-2791-schema/">open source repository</a>. The <a href="https://www.federalregister.gov/documents/2020/07/22/2020-15771/electronic-submissions-data-standards-support-for-the-international-institute-of-electrical-and">July 22nd, 2020 edition</a> of the Federal Register announced that the <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">FDA</a> now supports the use of BioCompute (officially known as IEEE 2791-2020) in regulatory submissions, and the inclusion of the standard in the Data Standards Catalog for the submission of HTS data in <a href="https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/types-applications">NDAs, ANDAs, BLAs, and INDs</a> to <a href="/facts/Center_for_Biologics_Evaluation_and_Research/sXVhlqE1">CBER</a>, <a href="/facts/Center_for_Drug_Evaluation_and_Research/GXmqIjAk">CDER</a>, and <a href="/facts/Center_for_Food_Safety_and_Applied_Nutrition/C59Pl5Rc">CFSAN</a>.
</p><p>Originally started as a collaborative contract between the <a href="/facts/George_Washington_University/RBAg9f0r">George Washington University</a> and the <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a>, the project has grown to include over 20 universities, biotechnology companies, public-private partnerships and pharmaceutical companies including Seven Bridges and <a href="/facts/Harvard_Medical_School/jlqWerKX">Harvard Medical School</a>. The BCO aims to ease the exchange of HTS workflows between various organizations, such as the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers, and academic researchers. Due to the sensitive nature of regulatory filings, few direct references to material can be published. However, the project is currently funded to train FDA Reviewers and administrators to read and interpret BCOs, and currently has 4 publications either submitted or nearly submitted.
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BioCompute Object open-in-new

BioCompute Object