FAQs for Patients
For patients interested in
the AMBRA1 and loricrin Referral Service
The following FAQs are designed to answer the questions of patients. If you are a clinician, please see your dedicated FAQs here.
Which type of melanoma is suitable for the test?
Non-ulcerated melanomas staged as IA, IB, IIA and IIB have been shown to be responsive to the AMBRA1 and loricrin antibodies.
Who can order the test?
The test can only be ordered by your doctor as they need to ask the pathology department to prepare the tissue slides.
How do I order the test?
How much does the test cost?
The cost of the test from AMLo is £385 excluding VAT. This does not include pathology costs that your trust may charge to prepare the samples.
Do I have to pay for the test?
Currently the NHS does not routinely fund the AMBRA1 and loricrin test so you will have to pay for it yourself.
How do I pay for the test?
The test is still very new so until a dedicated payment system is established, you will need to contact AMLo at [email protected], or call us on 0191 580 7180. We will take your details and issue an invoice for the test.
How long does the test take?
After the dermatologist has confirmed the need for the test with pathology, the pathology team will need to send 5 x 4-micron sections of the melanoma to CellPath in Newcastle. From the point of receiving the sample CellPath will report the result back to the requesting clinician within 10 working days.
Can I order the test without my doctor's consent?
No, the test needs to be conducted with the doctor’s consent.
To whom will the test results go?
The test results will be sent from CellPath at Newcastle Hospitals to the referring clinician (your doctor) by secure email.
Does the NHS fund the test?
At present the AMBRA1 and loricrin test is not routinely funded by the NHS. Individual doctors will need to make the request for special case funding or make a business case request to their hospital.
Do private insurers fund the test?
At present the test is not routinely funded by private insurers. Individual doctors will need to make the request for special case funding to your insurer. AMLo is working with private providers so watch the website for updates.
Does the NHS routinely use the test?
The AMBRA1 and loricrin test is very new and so it has not yet been adopted into routine NHS practice. Watch the websites for updates.
Which bodies in the UK have approved/reviewed the test?
The AMBRA1 and loricrin test has been approved for use at CellPath by UKAS through their validation process.
Melanoma diagnosis occurred several years ago. Can the test still be conducted?
As long as enough tissue has been retained, the test can be conducted. However, for Stage IA diagnoses the standard follow up is 1–2 years and so AMLo only recommends retrospective use of AMBRA1 and loricrin on Stage IA melanomas of less than 2 years since diagnosis. For melanomas that were staged as IB, IIA or IIB the standard follow up is 5 years and so AMBRA1 and loricrin could be used on this stage of melanoma for up to 5 years post diagnosis.
How accurate is the test?
The antibodies to AMBRA 1 and loricrin have been tested on retrospective melanoma biopsies with up to 10 years clinical follow-up. They have now been validated in over 750 patients from UK, USA, Australia and Spain. The latest data set in over 400 Stage I and II melanomas demonstrated an NPV of 97.1% and sensitivity of 95.7% meaning that AMBRA1 and loricrin is very effective at identifying melanomas that are truly low risk.
Why is the test not available as a blood test?
The test uses the tissue taken during the initial biopsy or later wide layer excision. It is applied to this tissue to enable a pathologist to examine the melanoma and surrounding healthy skin under the microscope. No further surgery is required.
I am not in the UK. Can I order the test?
Job code: 2023/AMBLor/UK/0023(1)
Date of preparation: February 2023
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