Are you a medical director, or a founder, considering introducing testing services in your company? Whilst it may seem simple and inconsequential, offering biomarker testing to customers turns them into patients, and with that comes large medical, legal and ethical responsibilities. 

There are misconceptions at both ends of the spectrum. At the one end are those who consider that a wellness test isn’t important enough to require medical scrutiny; which is false, because we are revealing medically-relevant information that patients didn’t previously know. 

At the other end of the spectrum are those who think that this is a minefield that cannot be navigated; which is also false, because at the heart of this are the core principles employed in medicine globally. I have tried to concisely describe the key principles in this article. 

Here are the top 8 areas to consider before offering any test:

1. Is the group of tests clinically appropriate?
2. Are the tests appropriate for the mode of patient communication?
3. Are the tests appropriate for the timescales of the service?
4. How will pretest counselling be delivered?
5. Might the results be psychologically or socially sensitive?
6. Are there any post-testing pathways to follow with the results?
7. Is certification required?
8. How will unexpected critical results be managed?

 

Is the group of tests clinically appropriate?

Whilst the commercial department may identify the greatest demand for specific biomarkers, these will need to fit into a clinically coherent group of tests. In clinical practice tests are grouped together based on symptoms or conditions that will allow for a diagnosis, or the need for further tests, to be identified; the medical director must ensure that this motivation for testing isn’t forgotten in the search for commercial goals.  

 

Are the tests appropriate for the mode of patient communication?

It is important to consider how any pretest counselling or results will be communicated with the patient. If you can’t speak to your patients via telephone, or see them on video, are the tests that you are offering appropriate? 

Are the tests appropriate for the timescales of the service?

If the patient won’t get their test results immediately, consider if that is appropriate for that type of test. For example, if a patient is checking their CRP to assess for the risk of acute infection, they will need to have a test result the same day that the test is requested, and taken. 

How will pretest counselling be delivered?

A patient needs to be fully informed before purchasing, and taking, any test. Ensure that you have considered the following and how it translates practically within the service that you offer:

• Intended use of test – is this a screening test or a diagnostic test?
• Test accuracy – whilst exact numbers may not be required, is the patient aware how much weight they should place on the result?
• Significance of negative result – can a condition be ruled out with this test?
• Significance of positive result – can a diagnosis be made with this test?
• Information on condition – what is being tested for exactly?
• Test timing – does the patient know what time of day, or where in their menstrual cycle, a test needs to be taken?
• Pretest requirements – does the patient need to stop certain medication, such as biotin, for the test to be accurate?

Might the results be psychologically or socially sensitive?

For tests such as those for sexual health conditions, there needs to be consideration of:

• What medium will the results be delivered by?
• How will confidentiality be maintained?
• What opportunities for dialogue are there?
• What supporting information (ie patient education) is required?

Are there any post-testing pathways to follow with the results?

Consider if retesting is required as part of a care pathway. An example would be a test for levels of Anti-Mullerian Hormone, which needs to be repeated in 6 weeks; the patient should know this before buying the first test. 

Some tests may be for notifiable diseases; if so, the responsibility for reporting needs to be agreed with the laboratory or requesting clinician. Other tests, such as HIV require retesting and/or onward referral to local services; how will this be delivered?

Is certification required?

Tests for communicable disease or test that are part of an occupational health assessment will require a confirmatory certificate. If the test is being used in this way, it is necessary to confirm the identity of the patient, ensuring the name on the certificate is that of the person who took the test. 

How will unexpected critical results be managed?

Even so called “wellness tests” may produce results which are unexpectedly out of range, or critical. To manage these, it is important to consider:

• Have appropriate patient contact details been gathered?
• Has the patient consented to sharing their data?
• What system will be in place to allow for a patient to be contacted?
• What will happen if it’s not possible to contact a patient?