METADATA
last updated: 2026-03-20 RT initial creation
file_name: _AI_COVID_Rights_of_Reference_Report.md
file_date: 2026-03-20
title: FloodLAMP COVID-19 Diagnostic Rights of Reference Report
category: regulatory
subcategory: open-euas
tags: rights-of-reference, quantigen, fda-eua, specimen-collection, gates-foundation, cdc-test, audere, swab-stability
source_file_type: md
xfile_type: NA
gfile_url: https://docs.google.com/document/d/1n4ar7uEMzZyuUtB83u_ZsV3toSBnENrCuplmOPp3wFs
xfile_github_download_url: NA
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pdf_github_url: NA
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conversion: NA
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 5611
words: 3516
notes: Created by [model not specified by user] during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Analysis of public, broad, and private rights of reference in the COVID-19 FDA EUA ecosystem, with primary focus on Quantigen Biosciences' specimen-collection stability data. Key sources include FDA COVID-19 test development FAQ, FDA EUA summaries, FDA virtual town hall transcript, user-supplied Gates Foundation presentation, and Padgett et al. PLOS ONE paper.
summary_short: COVID-19 diagnostic rights of reference report analyzing public, broad, and private rights of reference in the FDA EUA ecosystem, with primary focus on Quantigen Biosciences' specimen-collection stability data. Identifies four broad/public COVID-era RoRs (CDC assay, CDC Flu SC2, Quantigen swab stability, Emory/CHOA pediatric self-swab), documents widespread reuse of Quantigen's RoR across unrelated sponsors, and distinguishes broad/public RoRs from private bilateral and master-file-based arrangements.


CONTENT

## Prompt (Cleaned)
Analyze whether COVID-era FDA rights of reference were ever made broadly and publicly available, not just through private bilateral arrangements. Focus especially on Quantigen Biosciences' specimen-collection stability data. Identify the main publicly documented examples of broad/public rights of reference, explain how they were used across the EUA ecosystem, and distinguish between broad/public RoRs and private/master-file-based RoRs. Include analysis of a user-supplied Gates Foundation presentation on dry nasal specimen transport and collection methods.

**Files included in context window:**
`various/external-programs-reports/2020-09-17_Gates Foundation - Collection of Nasal Specimens and Dry Transport.pdf`


# COVID-19 diagnostic rights of reference
Public, broad, and other rights of reference used in the FDA EUA ecosystem, with a primary focus on Quantigen Biosciences

_Prepared March 18, 2026 by ChatGPT 5.4 Pro. This report is based on public FDA materials, selected EUA summaries, peer-reviewed literature, and the user-supplied Gates Foundation presentation. Because many bilateral rights of reference are not publicly disclosed, the public record is likely incomplete._


## Bottom line
- The public FDA record supports the user's core intuition: rights of reference (RoRs) can be granted specifically to one developer, or they can be granted broadly/publicly so that any qualifying developer may rely on previously reviewed data without receiving the underlying proprietary dataset. [1][3][4]
- In the public COVID-19 materials I reviewed, the clearest broad/public examples are: CDC's 2019-nCoV RT-PCR Diagnostic Panel, CDC's Flu SC2 Multiplex Assay, Quantigen Biosciences' swab-stability data, and Emory University/Children's Healthcare of Atlanta's pediatric self-swabbing data in MAF3543. [1][2]
- Quantigen appears to be the most important public specimen-collection/shipping example: FDA repeatedly described it as available to any sponsor pursuing an EUA, and multiple unrelated EUA summaries reused it. [1][3][7][8][9][10][11][19][20]
- I did not find official FDA language expressly saying these broad/public RoRs were royalty-free or fee-free. What the public record does show is that developers generally did not need a bespoke, one-off permission letter when a broad/public RoR had already been announced. [1][3]


## 1. Scope, method, and limitations
- Primary question answered: whether COVID-era rights of reference were ever made broadly and publicly available, especially in an 'open' practical sense rather than only through private bilateral arrangements.
- Priority sources: FDA's COVID-19 test development FAQ, FDA's In Vitro Diagnostics EUA page, FDA EUA summaries, FDA virtual town hall transcript, the user-supplied Gates Foundation presentation, and selected peer-reviewed papers. [1][2][3][5][6]
- Important limitation: private or confidential RoRs often do not appear in public FDA summaries. The absence of a public statement does not mean no RoR existed; it may simply have been handled privately through a letter or master file. [1][4]
- Terminology note: in this report, 'public' or 'broad' RoR means the data holder publicly announced that any qualifying sponsor/developer could rely on the FDA-reviewed data. That does not necessarily mean the raw data themselves were made public. [1][3]


## 2. What a right of reference is in the FDA/EUA context
FDA explains that a right of reference allows a new test developer to rely on validation data that FDA already reviewed for another COVID-19 test EUA, even though the new developer does not get direct access to the underlying proprietary data. FDA can consider the data because it already has them from the original developer or researcher. [1]

- Specific or bilateral RoR: the usual case. FDA says a sponsor seeking to leverage another party's data should include a letter from the original developer/researcher granting a specific right of reference, unless that party has already publicly announced a broad RoR. [1]
- Broad/public RoR: a publicly announced permission that applies to any qualifying developer or sponsor. During COVID-19, FDA's FAQ expressly identified a small set of these. [1]
- Master-file-based RoR: the data may stay in a confidential FDA master file, while the applicant submits a RoR letter from the master-file holder. FDA's general combination-products FAQ expressly describes this mechanism for proprietary, trade-secret information. [4]
- Operational meaning: a broad/public RoR can reduce duplicate validation work and shorten submissions, but the new developer still needs to show that its own test, specimen type, workflow, and labeling fit within the validated use case. [1][3][18]

| RoR type | How it works | What is public vs. non-public | Typical COVID-era example(s) |
| --- | --- | --- | --- |
| Specific / bilateral | Original holder gives a sponsor-specific letter allowing FDA to rely on already-reviewed data. | The permission may be referenced publicly, but the underlying data can remain non-public. | RapidRona to PacificDx for collection-kit data; Everlywell to Exact Sciences for its home kit. [14][20] |
| Broad / public | Original holder publicly announces that any qualifying sponsor or developer may leverage certain FDA-reviewed data. | The permission is public; the underlying dataset may still remain with FDA and/or the original holder. | CDC EUA200001; CDC Flu SC2; Quantigen swab stability; Emory/CHOA pediatric self-swab MAF3543. [1][2] |
| Master-file-based | Applicant cross-references a device or other master file and provides a RoR letter from the master-file holder. | The master file is confidential to FDA; the applicant need not receive the protected data. | DNA Genotek device master file for Ambry saliva collection; various instrument/quality-system references. [4][13][19] |
| | | | |


## 3. Broad/public COVID-era rights of reference identified in the public record
In the public FDA materials I reviewed, I identified four clearly articulated COVID-era broad/public RoRs. I am intentionally describing this as a public-record finding, not as a claim that only four ever existed in practice. Private RoRs could have existed without being publicly posted. [1][4]

| Data holder | Public scope described by FDA | What other developers could leverage | Why it matters |
| --- | --- | --- | --- |
| CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (EUA200001) | Right of reference to any test developer seeking an EUA for a COVID-19 diagnostic device. [1][2] | Performance data in the EUA request, especially for assays similar to the CDC assay; many developers used this to rely on CDC inclusivity and cross-reactivity work. [1][15][16] | This is the canonical pandemic-era blanket assay-data example. |
| CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (EUA201781) | Right of reference to any test developer seeking an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2. [1] | Performance data for similar multiplex respiratory panels; FDA also notes CDC published primer/probe sequences on CDC's website. [1] | Important expansion from single-analyte COVID testing into multiplex respiratory testing. |
| Quantigen Biosciences swab-stability data | Right of reference to any sponsor wishing to pursue an EUA. [1] | Analytical validation data supporting sample stability for foam or polyester nasal swabs shipped dry or in saline for authorized molecular assays. [1][8][10] | This is the clearest publicly available specimen-collection/shipping RoR and the main example for the user's project. |
| Emory University and Children's Healthcare of Atlanta pediatric self-swabbing study (MAF3543) | Broad RoR for any entity seeking an EUA for supervised pediatric self-sampling of anterior nares samples in ages 4-14. [1] | Performance data and collection protocols from the pediatric self-swab study, together with the new developer's own supporting data. [1][17][18] | Shows that a RoR can be both broad/public and master-file-based at the same time. |
| | | | |


## 4. Quantigen Biosciences: the main public specimen-collection right of reference

### 4.1 Why Quantigen mattered
- Early in the pandemic, swab and media shortages made it important to validate alternatives to foam swabs, nasopharyngeal collection, and viral transport media (VTM). The Gates Foundation presentation and the PLOS paper both frame the work in exactly that supply-constrained context. [5][6]
- The Gates deck shows the transition from foam to spun polyester swabs, the comparison of saline versus VTM, and the push toward dry transport for home or decentralized collection. [5]
- The PLOS paper states that polyester nasal swabs stored in dry tubes offered a robust and inexpensive self-collection method and links the work to the later HealthPulse@home kit. [6]

### 4.2 What FDA says the Quantigen RoR covered
FDA's FAQ states that Quantigen Biosciences granted a right of reference to any sponsor wishing to pursue an EUA and that FDA reviewed analytical validation data from a Quantigen swab-stability study, supported by the Gates Foundation and UnitedHealth Group, that could be used with other sponsor data to support sample stability of foam or polyester nasal swabs shipped dry or in saline for authorized SARS-CoV-2 molecular assays. [1]

- The FDA virtual town hall provides the clearest plain-English explanation: FDA staff described the Gates-sponsored Quantigen work as a 'global auto reference' and clarified that developers did not need to go back to Gates/Quantigen for an individual permission letter if they were matching the validated procedures. [3]
- FDA also emphasized in the town hall that the broad RoR was to specific data studies, not to a particular branded home-collection kit. In other words, the usable asset was the validated stability evidence and workflow, not a turnkey product authorization. [3]
- This distinction is especially relevant for projects trying to build new collection kits or adapt existing assays to dry or saline anterior-nares workflows. [1][3]

### 4.3 What the underlying Quantigen program appears to have shown
- The user-supplied Gates deck attributes to Quantigen the findings that foam and polyester nasal swabs performed well when eluted in PBS in the lab, and that dry foam and dry polyester swabs had better time/temperature stability than saline in the tested conditions. [5]
- The same deck gives a Quantigen dry-swab elution workflow: add 1 mL PBS to the dry swab tube, vortex 30 seconds with intermittent pulsing, and incubate at room temperature for at least 10 minutes before extraction; swirling or passive incubation without vortexing is marked 'not recommended.' [5]
- The Padgett et al. paper describes warm-climate, cold-climate, and freeze-thaw stress testing and concludes that polyester swabs stored dry were stable under shipping-relevant conditions and suitable for self-collection. [6]
- The PLOS paper also states that the work was provided to FDA and made available via a right of reference, which is consistent with the later FDA FAQ language. [6]

### 4.4 Evidence that Quantigen's RoR was widely reused
Multiple unrelated EUA summaries cite the same Quantigen RoR language or use it to support sample-stability claims. That pattern is strong evidence that the RoR was not merely theoretical; it was actually used across the EUA ecosystem. [7][8][9][10][11][19][20]

| Representative EUA summary | How Quantigen was used | Public signal of breadth |
| --- | --- | --- |
| Stanford Health Care / Vera collection kit | Stanford states that Quantigen demonstrated up to 56-hour stability for dry anterior nasal spun polyester swabs; Stanford says Quantigen granted a right of reference to any sponsor such as Stanford, so Stanford did not run a separate dry-shipping stability study. [7] | Shows concrete reuse by a separate lab-developer and direct substitution for duplicate stability work. |
| Helix COVID-19 Test | Helix states FDA reviewed Quantigen's Gates/UHG-supported swab-stability data and that Quantigen granted a RoR to any sponsor wishing to pursue an EUA. [8] | Shows the language migrated into a major national testing program. |
| KPMAS COVID-19 Test | KPMAS cites Quantigen's summer-profile saline stability study and the RoR to any sponsor. [9] | Shows the RoR was still in active use well after 2020. |
| iC SARS-CoV-2 / Tempus kit | iC says Quantigen granted a RoR for summer shipping stability data, while Tempus ran its own winter study. [19] | Illustrates the practical pattern: broad RoR for what already existed, sponsor-generated data for conditions not already covered. |
| Exact Sciences SARS-CoV-2 test | Exact Sciences cites Quantigen for saline-shipping stability and adds its own robustness-of-elution work. [20] | Another example of mixed reliance: borrow broad stability data, then add assay- or kit-specific supporting data. |
| Audere HealthPulse@home / Fusion | Audere's EUA materials rely on Quantigen's general RoR for the foundational dry/saline stability program. [10][11] | Shows Quantigen became an enabling layer under later kit platforms rather than a one-off study. |
| | | |

### 4.5 Gates Foundation, UnitedHealth Group, and Audere
- FDA's FAQ explicitly says the Quantigen stability study was conducted with support from the Gates Foundation and UnitedHealth Group. [1]
- The user-supplied Gates deck is itself a Gates Foundation presentation by Karen Heichman and repeatedly attributes dry-transport and elution work to Quantigen. [5]
- The PLOS publication lists an Audere author (Shawna D. Cooper) and says the project was funded primarily by the Bill & Melinda Gates Foundation through a direct award to Quantigen Biosciences and Audere. [6]
- The Gates deck also shows that Audere's role was not limited to generic graphics: slide 3 says 'Instructions developed by Audere,' and slide 11 says SteriPack worked with Audere on customized labeling and a 2D-barcode-linked instruction workflow. [5]


## 5. Short summary of the user-supplied Gates Foundation presentation
The uploaded presentation--"Collection of Nasal Specimens and Dry Transport" (September 17, 2020)--fits well as supporting context for the Quantigen section because it connects specimen-choice, swab supply, transport conditions, elution workflow, and scale-up planning into one narrative. [5]

- Slides 2-3: present evidence that nasal swabs were acceptable and accessible compared with nasopharyngeal/oropharyngeal collection, and emphasize instruction quality; slide 3 explicitly credits Audere with developing collection instructions. [5]
- Slides 4-6: explain why spun polyester swabs were evaluated during foam-swab shortages and report that polyester performed equivalently to foam, with better concordance in saline than VTM. [5]
- Slide 5: highlights the practical shift away from VTM, noting saline as acceptable and pointing to Quantigen's findings that dry foam and polyester swabs had superior stability versus saline under the tested stress conditions. [5]
- Slide 7: provides the dry-swab elution protocol validated by Quantigen--1 mL PBS, 30 seconds of vortexing, and at least 10 minutes of room-temperature incubation before extraction; two lower-agitation alternatives are labeled not recommended. [5]
- Slides 8-10: describe the dry-stability study design and summarize the resulting time/temperature performance for dry foam, dry polyester, and saline arms. [5]
- Slides 11-13: move from validation science into manufacturing and deployment, discussing US Cotton, SteriPack, labeling/barcoding support from Audere, and the case for a low-cost dry-swab kit. [5]
- Slides 14-15: broaden the relevance beyond SARS-CoV-2 toward influenza and TB applications and identify other Gates-supported grantees working on oral and nasal swab pathways. [5]

_One cautionary note: slide 12 is explicitly marked 'CONFIDENTIAL.' I therefore used the deck mainly for the non-confidential scientific and workflow narrative rather than for any business-sensitive slide content. [5]_


## 6. Audere: important participant, but not the same type of RoR as Quantigen
The public record supports a more substantial Audere role than 'just the graphics,' but it also shows that Audere's own RoR model was generally more controlled and contractual than Quantigen's broad/public stability RoR. [5][6][10][11][12]

- Audere appears in three layers of the record: (1) collection instructions in the Gates deck, (2) co-authorship/funding in the Padgett paper, and (3) later EUA-authorized collection-kit platforms such as HealthPulse@home and HealthPulse@home Fusion. [5][6][10][11]
- The HealthPulse@home EUA summary says that, upon contracting with Audere, authorized laboratories may reference certain Audere validation data and that 'a RoR will be provided' by Audere upon contracting. That is useful, but it is not the same as Quantigen's openly announced RoR to any sponsor. [10]
- HealthPulse@home Fusion likewise limits use to laboratories designated by Audere, even while relying on Quantigen's broader RoR for core stability support. [11]
- The CDC 2019-nCoV IFU also states that Audere granted CDC a right of reference to the performance data supporting the HealthPulse@home and HealthPulse@home Blueprint kits. This is another real RoR, but it is a targeted one tied to specific kit use rather than a general public RoR like Quantigen's. [12]


## 7. Other relevant RoR examples beyond Quantigen and CDC

### 7.1 Other broad/public example found
- Emory University and Children's Healthcare of Atlanta: FDA says their pediatric self-swabbing study was submitted in Master File MAF3543 with a broad right of reference for any developer seeking supervised pediatric self-collection in ages 4-14. [1]
- FDA later cited this Emory/CHOA collaboration as an example of a right of reference that shortened both sponsor preparation time and FDA review time. [18]
- The supporting JAMA article reported high agreement between self-collected and healthcare-worker-collected nasal swabs in symptomatic children ages 4-14 after simple age-appropriate instructions. [17]

### 7.2 Narrower, private, or master-file-centered examples
- RapidRona -> PacificDx: PacificDx's EUA summary states that RapidRona granted PacificDx a right of reference to the data supporting RapidRona's self-collection kit. This is a classic specific, product-centered RoR. [14]
- DNA Genotek -> Ambry: Ambry's saliva test summary says DNA Genotek granted Ambry a RoR to information in the relevant device master file for the OMNIgene oral saliva collection device. This is a clear confidential/master-file example. [13]
- Audere -> contracting laboratories: Audere's HealthPulse summaries describe RoRs supplied to laboratories upon contracting, which is broader than a one-off bespoke letter but still not publicly open in the Quantigen sense. [10][11]
- Instrument and platform examples also exist. For example, the iC SARS-CoV-2 summary says Thermo Fisher granted a right of reference to any sponsor wishing to pursue an EUA for data addressing RUO qualification of a specific PCR instrument. This is a 'blanket' technical RoR, but narrower in scope than the CDC or Quantigen public examples. [19]


## 8. Conclusions for the present project
- Yes--the public record supports the statement that RoRs during the COVID-19 EUA period could be granted openly/publicly as broad RoRs, not just confidentially. CDC and Quantigen are the two strongest examples for your stated use case, with Emory/CHOA as another clear example. [1][2][3]
- Yes--the public record also supports the statement that RoRs can be handled privately or confidentially, including through master files and sponsor-specific letters. FDA's general master-file FAQ and multiple EUA summaries support that point. [4][13][14]
- Quantigen should be the report's main specimen-collection example because it combined: public breadth, FDA acknowledgement, Gates/UHG support, dry and saline transport relevance, repeated reuse across unrelated sponsors, and direct relevance to home or decentralized swab workflows. [1][3][7][8][9][10][11][19][20]
- Audere should be discussed as an important collaborator and later platform implementer, but distinguished from Quantigen: Audere's public record points more toward kit instructions, implementation tooling, and contracting-based RoRs than toward a universally open RoR. [5][6][10][11][12]
- I would avoid saying 'free of charge' or 'no license fee' as a hard factual claim unless you have separate documentary support. The public FDA record shows broad/public permission, but I did not find an official statement on pricing or royalty terms. [1][3]


## 9. Practical drafting language you can reuse
If you want a concise regulatory-style formulation for your own materials, the following language is well supported by the public record:

### Suggested language
- 'A right of reference allows FDA to rely on validation data previously reviewed for another EUA submission without disclosing the underlying proprietary data to the new sponsor. During the COVID-19 emergency, some rights of reference were granted broadly and publicly--for example, CDC's broad rights of reference for certain assay data and Quantigen Biosciences' broad right of reference for certain SARS-CoV-2 swab-stability data--while many others were granted privately through sponsor-specific letters or master files.'


## References
[1] U.S. Food and Drug Administration (FDA), "COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2," current page dated Apr. 25, 2024. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2

[2] FDA, "In Vitro Diagnostics EUAs." https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas

[3] FDA, "Virtual Town Hall Series -- Coronavirus (COVID-19) Test Development and Validation -- March 31, 2021" (transcript). https://www.fda.gov/media/147394/download

[4] FDA, "Frequently Asked Questions About Combination Products," section on use of master files and right of reference letters. https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products

[5] Bill & Melinda Gates Foundation, Karen A. Heichman, "Collection of Nasal Specimens and Dry Transport: Methods and Results from BMGF Grantees and Colleagues," Sept. 17, 2020. User-supplied presentation.

[6] Padgett LR, Kennington LA, Ahls CL, et al. "Polyester nasal swabs collected in a dry tube are a robust and inexpensive, minimal self-collection kit for SARS-CoV-2 testing." PLOS ONE 16(4): e0245423 (Apr. 14, 2021). https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245423

[7] Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 test EUA Summary (FDA PDF 136818). https://www.fda.gov/media/136818/download

[8] FDA, "Helix COVID-19 Test -- EUA Summary." https://www.fda.gov/media/140420/download

[9] FDA, "KPMAS COVID-19 Test -- EUA Summary." https://www.fda.gov/media/139067/download

[10] FDA, "Audere HealthPulse@home -- EUA Summary." https://www.fda.gov/media/154583/download

[11] FDA, "Audere HealthPulse@home Fusion -- EUA Summary." https://www.fda.gov/media/158135/download

[12] FDA, "CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel -- Instructions for Use." https://www.fda.gov/media/134922/download

[13] FDA, "Ambry COVID-19 RT-PCR Test -- EUA Summary." https://www.fda.gov/media/145410/download

[14] FDA, "PACIFICDX Covid-19 Test -- EUA Summary." https://www.fda.gov/media/144558/download

[15] FDA, "BU SARS-CoV-2 Test -- EUA Summary." https://www.fda.gov/media/165306/download

[16] FDA, "Orig3n 2019 Novel Coronavirus (COVID-19) Test -- EUA Summary." https://www.fda.gov/media/136873/download

[17] Martin GS, et al. "Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents." JAMA (published Aug. 26, 2022). https://jamanetwork.com/journals/jama/fullarticle/2795837

[18] FDA, "MDP Sept. 8, 2023 FDA Executive Summary." https://www.fda.gov/media/171779/download

[19] FDA, "iC SARS-CoV-2 Test -- EUA Summary." https://www.fda.gov/media/142596/download

[20] FDA, "SARS-CoV-2 (N gene detection) Test -- EUA Summary" (Exact Sciences). https://www.fda.gov/media/138328/download