attomarker

Attomarker COVID Antibody Spectrum Test (United States)

CE Marked Technology Platform

UKCA Marked Test Certified

Developed with University of Exeter

Access under Compassionate Use

The Attomarker COVID Antibody Spectrum Test is currently authorised under UKCA for use in the United Kingdom, on our CE-marked platform. It is not yet approved or cleared by the U.S. Food and Drug Administration (FDA). In the United States, it is available only under Compassionate Use provisions, in accordance with FDA Expanded Access regulations.

Compassionate Use provides a route for individuals to access diagnostic technologies that are not yet approved in the U.S., where there is a reasonable expectation of potential benefit, no satisfactory alternative, and appropriate medical oversight.

Access Criteria

Access to the test is limited to individuals who confirm that they:

  • Have persisting symptoms consistent with Long Covid, or
  • Have received a clinical diagnosis of Long Covid, or
  • Are under medical supervision and have been advised that immune evaluation may be appropriate.

By confirming one of the above, you automatically establish eligibility to request access under Compassionate Use.

About the Test

The Attomarker COVID Antibody Spectrum Test is a quantitative multiplex blood test that measures both the quantity and quality of antibodies to multiple variants of SARS-CoV-2. It provides a detailed profile of immune response patterns that may inform ongoing care or research into post-COVID conditions. 

You may learn more about the Persistent Virus Hypothesis here:
Persistent Virus Hypothesis

The test identifies three broad immune response profiles (endotypes):

Endotype
Hypoimmune
Hyperimmune
Universal Responders
Description
Low antibody levels and/or poor antibody quality.
Unusually high antibody levels or exaggerated response.
Antibody patterns consistent with an effective immune response.

Interpretation should always be undertaken in conjunction with a qualified healthcare professional.

You may learn more about Endotypes here:
Endotypes in Long Covid

Access Process for U.S. Patients

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1. Submit a Compassionate Use Request

Complete the form below to request access. You will be asked to:

  • Confirm that you meet one of the eligibility criteria listed above (have persisting symptoms consistent with Long Covid, or have received a clinical diagnosis of Long Covid, or are under medical supervision and have been advised that immune evaluation may be appropriate.)
  • Provide your contact information.
  • Confirm your clinician or clinical advisor (including name, professional title, and contact email).
  • Confirm that your nominated clinician has agreed to receive and review your results on your behalf.
  • Provide consent for Attomarker and its authorised partners to share your results securely with that clinician.

 

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2. Cost Recovery

A cost recovery contribution of $400 USD is required to cover laboratory processing, logistics, and reporting. This amount does not constitute a purchase and does not imply FDA approval or commercial sale. This is collected by Stripe payment on submission of form.

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3. Compassionate Use Review

Each request will be reviewed by designated scientist affiliated with the Attomarker Compassionate Use programme. Approval will be confirmed before sample collection materials are dispatched.

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4. Sample Collection and Testing

You will receive a sample collection kit and instructions for blood sample collection, along with secure shipment to our authorised sample preparation and transfer laboratory in the United States. They are responsible for ensuring the blood sample reaches our UK laboratory safely.

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5. Test Processing

Once we have received your blood sample from our US laboratory partner, we conduct the full 15 variant analysis of your COVID antibody immune profile in our Exeter University Science Park Laboratory
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6. Results Provision

After the results have gone through our normal QA process and have been finalised, they are then returned to your designated physician by email, copied to you if you have confirmed a desire to also receive them directly, in the form of a comprehensive PDF report.
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7. Interpretation & Ongoing Care

You should then discuss the results in conjunction with your care team to consider how this applies to you and your care journey in Long Covid.

Reporting and Follow-Up

After testing, your results will be securely provided to your nominated clinician or advisor. The report describes your antibody responses across multiple COVID variants and identifies your immune endotype.

Results are provided for informational and research purposes only and do not represent a diagnosis or treatment recommendation. Any interpretation or follow-up action should be made by your clinician.

Important Notices and Disclaimers

  • The Attomarker COVID Antibody Spectrum Test is not FDA-approved and not intended to diagnose, treat, cure, or prevent any disease in the United States.
  • Access is limited to Compassionate Use arrangements for individuals confirming eligibility and medical oversight.
  • Results are for informational and research use only.
  • Any clinical decision or treatment should be made under the supervision of a licensed healthcare professional.
  • By submitting a request, you confirm your understanding of the test’s regulatory status and consent to your data being handled under these conditions.

Submit a Compassionate Use Access Request