Diagnostics PR services: how tests and labs earn credible coverage

Diagnostics PR services help test makers, labs and digital diagnostics companies earn coverage that clinicians, investors and patients will trust. That trust is harder to win than in most of health: a diagnostics story is, at heart, a claim about accuracy, and journalists, regulators and competitors all know how to check one.

This guide is for founders, marketers and lab leaders deciding how to run diagnostics PR, in-house or with an agency. It covers how to describe accuracy honestly, the US, EU and UK regulatory backdrop, the extra care at-home tests need, what the Theranos case changed, the story angles that work and what to look for in a partner.

What do diagnostics PR services cover?

The FDA describes in vitro diagnostics (IVDs) as tests done on samples such as blood or tissue taken from the body, and says these products are devices under the Federal Food, Drug, and Cosmetic Act, classified like other devices into Class I, II or III. Some are used in laboratories and clinics; others are sold for people to use at home. Diagnostics PR usually serves four kinds of company:

• IVD manufacturers selling kits, analysers and assays to labs and hospitals.
• Clinical and specialist laboratories, including those running their own laboratory developed tests.
• At-home and direct-to-consumer test brands.
• Digital diagnostics companies, such as software that reads images or signals.

The work itself spans launch announcements, validation and study news, expert comment for health and trade journalists, clinician and trade press relations, and issues handling when a result, a recall or a competitor’s claim makes the news. Launches follow the same regulatory logic as other devices; our medtech product launch guide covers the cleared-versus-approved wording, pre-clearance limits and embargoes in detail.

What separates good medtech and diagnostics PR from general tech PR is that every story has to stand up to a clinician reading the numbers.

Why do accuracy claims make or break a diagnostics story?

Most diagnostics coverage turns on one sentence about how well the test works. Get that sentence right first.

Two terms carry most of the weight. In a BMJ statistics note, Altman and Bland define sensitivity as the proportion of true positives the test correctly identifies, and specificity as the proportion of true negatives it correctly identifies. Both are measured against a reference standard: the best available way of knowing who really has the condition.

When the comparison isn’t against a reference standard, the FDA’s 2007 statistical guidance on diagnostic test studies says not to use “sensitivity” and “specificity” at all. The same calculations should be reported as positive percent agreement and negative percent agreement, with the comparator described, the two-by-two table shown and confidence intervals given. The guidance also warns that “‘Agreement’ does not mean ‘correct.’”

For a press release, that turns into a short checklist:

• Name the measure (sensitivity, specificity, or positive and negative percent agreement) and what it was compared against.
• Give the study size, setting and population, and the confidence interval.
• Avoid a single “accuracy” figure; it hides the difference between missed cases and false alarms.
• Say what the test is for and who it isn’t for, and what a positive or negative result means for the person tested.
• Have a clinician or biostatistician check the numbers before the release goes out.

A well-informed health journalist may ask for the two-by-two table. If you can’t share it, be ready to explain why.

The regulatory backdrop for diagnostics PR

Regulatory status shapes what you can say, and in diagnostics it has changed recently in both the US and Europe.

Laboratory developed tests in the US

The FDA defines a laboratory developed test (LDT) as an IVD that is designed, manufactured and used within a single laboratory. In 2024 the FDA amended its IVD definition to include tests made by laboratories. On 31 March 2025, a federal district court in Texas vacated that rule, in American Clinical Laboratory Association v. FDA, and on 19 September 2025 the FDA issued a final rule restoring the regulation’s previous text. If you run an LDT, describe it accurately as a laboratory developed test and don’t imply FDA clearance or approval it doesn’t have.

IVDR transition in the EU

The EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) replaced the old directive on 26 May 2022. Ireland’s regulator, the HPRA, summarises the extended transition deadlines for devices that already met the old rules: 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and sterile Class A. The extension only applies if conditions are met, including no significant change to the device’s design or intended purpose, a quality management system in place by 26 May 2025 and an application to a notified body by class-specific dates. Before announcing an EU launch or a “new version”, check which regime your test sits under.

Great Britain

The MHRA says CE-marked IVDs remain accepted in Great Britain until 30 June 2030 (for those under the old directive, until their certificate expires if that is sooner), and devices must be registered with the MHRA before they are placed on the market.

At-home tests and consumer claims

Consumer tests bring consumer protection law into play. The FTC’s Health Products Compliance Guidance (December 2022) says health benefit claims need “competent and reliable scientific evidence”, that randomised controlled trials are generally the kind of substantiation experts would expect, and that anecdotal evidence is never enough to support claims about a health product’s effects. Its preface lists cases involving diagnostic tests and health-related apps, and says the same legal principles apply to marketing any health-related product.

The FTC’s file shows how accuracy claims can go wrong. In December 1999 it charged an internet marketer of home HIV tests who promoted “99% sensitivity and 99% specificity”; the FTC alleged that when the tests were tried on HIV-positive blood, nine of ten gave false negatives and the tenth didn’t work. That was an allegation in a complaint, not a court finding, but the lesson for PR is plain: a headline accuracy figure will be tested.

Honest communication about limits is also part of the story. In 2022 the FDA warned that at-home COVID-19 antigen tests can give false negative results and recommended repeat testing after a negative: at least two tests 48 hours apart for people with symptoms, and at least three for people without symptoms who may have been exposed. A consumer test brand that explains what a negative result does and doesn’t mean, in plain words, gives journalists a more useful story than one that leads with a single accuracy figure.

For the wider rules on testimonials, influencers and UK advertising, see our guide to health claims and PR compliance.

Credibility: what the Theranos case changed

On 14 March 2018 the US Securities and Exchange Commission charged Theranos, its founder and chief executive Elizabeth Holmes, and its former president Ramesh “Sunny” Balwani with raising more than $700 million through what the SEC called “an elaborate, years-long fraud”. The SEC alleged that the company’s portable blood analyser could run only a small number of tests, and that most patient tests were run on analysers made by other companies. Holmes settled without admitting or denying the allegations, agreeing to a $500,000 penalty and a ten-year bar from serving as an officer or director of a public company.

For anyone doing diagnostics PR now, the case raised the bar on evidence. Expect journalists to ask:

• Has the validation been published in a peer-reviewed journal, or only announced?
• Was it done or checked by anyone independent of the company?
• What exactly does the test run on, and in what setting were the results produced?
• Will an independent clinician or lab scientist comment on the record?

The safest order is to publish, then publicise. Announcing performance figures that haven’t been peer reviewed invites exactly the scrutiny you least want at launch.

Story angles that work for diagnostics companies

Diagnostics companies have more angles than they think. The ones that tend to land:

• A published validation study, explained by a named author, with the numbers in context.
• The care-pathway story: what changes for patients and clinicians when a result arrives sooner, closer to home or without a second appointment.
• When to test, and when not to: a lab scientist or clinician explaining which test suits which situation. Health desks value this, and it builds trust because it isn’t a sales pitch.
• Reactive expert comment when a condition, outbreak or screening debate is in the news.
• Accurately worded regulatory milestones, such as a clearance or a CE marking under the IVDR.
• Aggregate testing trends from your own data, if they are properly anonymised and analysed, and the method is shared.
• Awareness days for the condition your test detects, tied to a spokesperson rather than a discount.

Match each angle to an audience: lab and IVD trade titles for the business and technical story, clinician press for the evidence, and consumer health desks only when the public can act on it.

What to look for in a diagnostics PR partner

Whether you hire an agency, a freelancer or build the function in-house, look for:

• Medical-accuracy review. Someone who knows the difference between sensitivity and positive percent agreement should read every release before it goes out.
• Regulatory literacy. Cleared, approved, CE-marked, laboratory developed: the partner should use the right term without being reminded.
• Clinician and lab spokespeople, briefed and media trained, plus access to independent experts journalists will accept.
• Reach in the right press: lab and diagnostics trade titles, clinician publications and health desks, not just tech blogs.
• Honest reporting. Coverage shown and linked, with outcomes such as links, referral traffic and enquiries rather than vanity metrics. Our guide to measuring health PR sets out what a useful report includes.

At HealthSpark, every placement is shown and linked to the client. Retainers run $3,000 to $5,000 a month, and reactive expert placements cost $300 each, billed only when the placement is live.

This guide is general information, not legal advice.