FR 2021-00825

Overview

Title

Government-Owned Inventions; Availability for Licensing

Agencies

ELI5 AI

The government has a new test that can quickly find out if someone has COVID-19 and how sick they might get, and they're looking for people to help make it and use it.

Summary AI

The National Institutes of Health, part of the U.S. Department of Health and Human Services, has announced an invention available for licensing. This invention is a high-throughput COVID-19 diagnostic test that uses next-generation sequencing to simultaneously detect the virus and the host's response. It aims to provide accurate and fast testing on a large scale, with potential applications in detecting various infectious organisms. The technology reduces reagent use and can also help predict the severity of the disease based on gene expression.

Abstract

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development.

Type: Notice
Citation: 86 FR 4105
Document #: 2021-00825
Date:
Volume: 86
Pages: 4105-4106

AnalysisAI

The document from the Federal Register details a significant development by the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services. The NIH has introduced a novel diagnostic technology for COVID-19, aiming to streamline the testing process on a massive scale. This invention uses next-generation sequencing (NGS) to detect not only the virus but also the host's transcriptional response to the infection. This approach may offer substantial advantages, such as reducing the cost and material required for testing while enhancing the understanding of a patient's disease severity.

General Summary

The document serves as a public notice announcing the availability of a government-owned invention for licensing. The high-throughput COVID-19 diagnostic test aims to address the urgent need for large-scale, rapid, and reliable testing. By employing an advanced method, this test can significantly increase the capacity for COVID-19 testing and provide comprehensive insights into the host's response to the virus. Such advancements are crucial for managing and mitigating the effects of the pandemic effectively.

Significant Issues and Concerns

Several concerns arise from the document, particularly regarding the transparency and fairness of the licensing process. The notice does not detail how licensees will be selected, which might raise questions about potential bias or lack of transparency. Furthermore, the document's technical language could be challenging for lay readers to fully comprehend, limiting its accessibility. It's also important to note that gaining access to more unpublished information requires signing a Confidential Disclosure Agreement, potentially restricting the flow of crucial information to stakeholders who are not in a position to engage in such agreements.

Broad Public Impact

The implications of this invention for the public are considerable. If successfully commercialized, it could lead to faster, more efficient COVID-19 testing, significantly contributing to public health efforts by enabling widespread monitoring and early detection of the virus. The ability to assess a patient's transcriptional response could also influence treatment approaches, potentially leading to better patient outcomes.

Impact on Specific Stakeholders

For the scientific and medical community, this invention represents a significant step forward in diagnostic technology, with potential applications extending beyond COVID-19 to other infectious diseases. However, the requirement for a Confidential Disclosure Agreement before accessing detailed information might hinder some researchers or smaller companies from contributing to or benefiting from this advancement.

From a business perspective, companies able to secure licensing could capitalize on the test's commercial potential, leading to economic benefits. However, without detailed criteria for licensing, smaller entities may face challenges in entering the market, possibly limiting competition and innovation.

Overall, while the invention holds significant promise for public health advancements, transparency and accessibility in the licensing process will be key to maximizing its benefits and ensuring fair opportunities for stakeholders across various sectors.

Issues

  • • The notice does not explain any specific criteria or process for selecting licensees, which might raise concerns about potential favoritism or lack of transparency in the licensing process.

  • • The potential commercial applications and competitive advantages of the invention are described briefly; additional details could help assess the broad economic or public health impact.

  • • The document includes potentially complex technical language ('massively paralleled multiplexed screening method using next generation sequencing') that may not be easily understood by all readers.

  • • The document mentions the need for a signed Confidential Disclosure Agreement to obtain unpublished information, which may limit transparency and access to critical information for potential stakeholders who cannot engage in such agreements.

Statistics

Size

Pages: 2
Words: 564
Sentences: 25
Entities: 46

Language

Nouns: 203
Verbs: 43
Adjectives: 34
Adverbs: 7
Numbers: 30

Complexity

Average Token Length:
5.25
Average Sentence Length:
22.56
Token Entropy:
5.21
Readability (ARI):
17.70

Reading Time

about 2 minutes