Logo
  • Home
  • About
  • What we do
  • Partners
  • News
  • Resources
  • Careers
  • Contact
Biomarkers

Developing a biomarker? Keep these 3 take aways in mind

05 May 2021

Liesbeth Ceelen, General manager at BioLizard

 

Developing a biomarker – either for diagnosis or supporting drug development – is a costly and time-consuming process. Over the years, we’ve built up reliable experience concerning this topic. That’s why in this blog, we’ll talk about three key take aways when you develop biomarkers: one during biomarker discovery, one during biomarker development and one during biomarker validation.

 

Biomarker discovery: map out your gold standard

 

The goal of using a biomarker is to objectify a person’s physiological state. In general, a biomarker will…

…determine if a disease is present in someone,

…predict how a disease will develop,

…or predict the response of a specific therapy.

However,  before a biomarker can do this, you will need to know what you are looking for. The starting point of biomarker development relies on a specific disease detection gold standard: if the test result of the measured biomarker comes back positive, this result will also need to be validated independently.

If you don’t have a gold standard for what you are objectifying, it’s impossible to develop a biomarker. For example, how can you make a biomarker for chronic fatigue syndrome? There is no way to measure this disease objectively. If you can’t prove a disease is present in a patient, you can’t expect your biomarker to tell you either.

The next question that arises is: ‘If you can tell that someone has a particular disease, why even bother making a biomarker?’ An excellent example concerning this question comes from colorectal cancer, where polyps inside someone’s intestines can only be found by performing a colonoscopy. Only by locating and identifying these polyps, are you able to diagnose that this person has cancer. This is a clear gold standard. The examination is effective but only at a late stage of the disease and it is not very pleasant for the patient. Developing a liquid biopsy biomarker could make it less intrusive, and more pleasant for this patient. Most importantly: the biomarker could even detect colorectal cancer at an earlier stage, making it easier to treat and improving survivability.

In summary, to develop a biomarker, you need a good gold standard to identify what you are looking for, and it needs to add value to the diagnosis and treatment of a certain disease.

 

Biomarker development: enroll a high-risk population

 

The most time-consuming and resource-intensive stage for biomarker development is phase 3. To know if your biomarker detects or predicts the presence of a disease, or if the biomarker can indicate a response to a certain therapy, you need to have patients in your study that actually have the right profile. Enroll a high-risk population to have a more efficient, shorter, and cheaper testing stage.

Let’s have a look at bladder cancer. If you would develop a biomarker to identify this type of cancer, it’s a smart move to look at the specific symptoms and pathology of this cancer. People with bladder cancer tend to have blood in their urine. Does this mean that everyone with blood in their urine has bladder cancer? No, but the odds are a lot higher. This is your high-risk population. When testing your biomarker for bladder cancer, you need patients in your testing panel with blood in their urine.

Why is it so important to have a high-risk population in your study? Because if you don’t, you may need 100 000 subjects before you have enough cases that present with bladder cancer. When you reach out to patients with a higher risk, you will need fewer subjects for your study. Therefore, it makes it easier to show a more substantial effect, and as a result, your trials will be shorter and cheaper.

 

Biomarker validation: create a win-win situation

 

Many biomarkers fail after they get marketed. All those years of research, all the investments – gone. It doesn’t even matter that your biomarker does what it promises to do, because there is no gain for doctors or caregivers. These are the people who will eventually be using your biomarker. You need to make sure they see value in your biomarker.

To convince doctors & caregivers of your biomarker, conduct a cost-effectiveness study. Show them your biomarker also provides economic benefits. A biomarker should either save costs or improve the quality of life. Preferably both. Also, make sure you prove this country by country. Work-operations, procedures, and pricing of diagnostics change per country. This makes your biomarker’s position and marketability change wherever you go around the globe.

 

In short

When developing a biomarker, keep in mind these three take aways:

Start with a gold standard of the disease your biomarker needs to identify.

Enroll a high-risk population during the biomarker testing stage.

Convince doctors and caregivers by showing both cost-effectiveness combined with medicinal benefits

When you keep these three key take aways in mind, your biomarker is more likely to be successful.

In addition to these three take aways, don’t forget the data that you generate throughout the whole process is your goldmine. Be sure to use and organize your generated data correctly when you develop biomarkers. We created an article about the most common pitfalls when developing biomarkers to help you. Be sure to check it out.

 

We’d love to help you develop a winning biomarker!

Get in touch

cta_blog2

Let's do something
great together

Contact us

Join the social
media discussion

Stay informed with
our latest news

Read our news
  • Home
  • About

©2022 BioLizard nv. All Rights Reserved. Design by Just Jax. Development by TYL.

  • Privacy Policy
Logo
Biolizard Cookie Consent Information

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.

Cookie SettingsAccept All

Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
CookieDurationDescription
bcookie2 yearsLinkedIn sets this cookie from LinkedIn share buttons and ad tags to recognize browser ID.
langsessionThis cookie is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc1 dayLinkedIn sets the lidc cookie to facilitate data center selection.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_gat_gtag_UA_164325847_11 minuteThis cookie is set by Google and is used to distinguish users.
_gat_UA-164325847-11 minuteThis is a pattern type cookie set by Google Analytics, where the pattern element on the name contains the unique identity number of the account or website it relates to. It appears to be a variation of the _gat cookie which is used to limit the amount of data recorded by Google on high traffic volume websites.
_gcl_au3 monthsProvided by Google Tag Manager to experiment advertisement efficiency of websites using their services.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
CookieDurationDescription
_fbp3 monthsThis cookie is set by Facebook to display advertisements when either on Facebook or on a digital platform powered by Facebook advertising, after visiting the website.
bscookie2 yearsThis cookie is a browser ID cookie set by Linked share Buttons and ad tags.
fr3 monthsFacebook sets this cookie to show relevant advertisements to users by tracking user behaviour across the web, on sites that have Facebook pixel or Facebook social plugin.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
CookieDurationDescription
a3aa548f857642d7ad9818410843280acd93d104c52e466aa7c59da011282bb01 yearNo description
AnalyticsSyncHistory1 monthNo description
li_gc2 yearsNo description
UserMatchHistory1 monthLinkedin - Used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
SAVE & ACCEPT
Powered by CookieYes Logo