Biomarkers include a wide range of things, including proteins, genes, metabolites, hormones, and other molecules that are measurable in biological samples (blood, urine, tissue, or saliva). The discovery of biomarkers is a crucial step in various fields, including medicine, clinical research, and diagnostics, and serves many important purposes.

What Biomarker Discovery Does

There are many examples of things biomarker discovery helps with. These things include helping doctors and researchers both identify and make recommendations for dealing with specific conditions.

Disease Diagnosis

Biomarkers can help in the early and accurate diagnosis of diseases. For example, specific proteins or genetic markers in blood can indicate the presence of certain cancers.

Disease Prognosis

Biomarkers can provide information about the likely course of a disease, its severity, and the potential response to treatment. This information can guide healthcare decisions.

Treatment Selection

Identifying biomarkers associated with drug response allows for the selection of the most effective treatment options for individual patients, a field known as personalized or precision medicine.

Monitoring Disease Progression

Biomarkers can be used to track the progression of diseases, such as the measurement of certain enzymes in heart disease patients to assess heart function.

Predictive Biomarkers

Some biomarkers can predict an individual’s susceptibility to a disease or adverse events. For example, certain genetic markers can indicate an increased risk of developing Alzheimer’s disease.

Pharmacodynamic Markers

Biomarkers can be used to monitor the effects of drugs on the body and ensure that the intended biological responses are occurring.

How Biomarker Discovery Works

The process of biomarker discovery typically involves a few steps that can differ from field to field.

Biomarker Hypothesis

Researchers formulate hypotheses about potential biomarkers based on existing knowledge, clinical observations, or data from previous studies.

Biomarker Screening

High-throughput technologies, such as genomics, proteomics, and metabolomics, are often employed to screen a large number of potential biomarkers in biological samples.

Data Analysis

The collected data is analyzed to identify statistically significant associations between specific biomarkers and the condition or process of interest.

Validation

Candidate biomarkers are further validated using independent datasets or additional experiments to confirm their reliability and relevance.

Clinical Testing

Promising biomarkers are evaluated in clinical studies involving patient populations to assess their diagnostic or prognostic value.

Regulatory Approval

If a biomarker proves to be clinically useful, it may undergo regulatory approval processes, such as those set forth by the FDA, before being used in clinical practice or diagnostics.

Clinical Implementation

Once validated and approved, biomarkers can be integrated into clinical practice for disease diagnosis, prognosis, or treatment decision-making.

Biomarker discovery is a constantly evolving field, driven by advances in technology and our increasing understanding of the molecular and genetic underpinnings of diseases. It holds great promise for improving disease diagnosis and treatment, as well as advancing our understanding of complex biological processes.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.

The post What Is Biomarker Discovery? appeared first on Biofortis Research.

Why Substantiating Food Industry Claims Is Important

Substantiating claims in the food industry is a critical part of ensuring that marketing and labeling claims made about food products are truthful, accurate, and supported by scientific evidence. These claims can encompass various aspects of a product, including nutritional content, health benefits, sourcing, and production methods.

How Substantiating Food Industry Claims Works

There is a general process that must be followed to substantiate food industry claims to get approval on labeling & marketing.

Food Claim Development

Companies develop specific claims they want to make about their products. These claims may relate to health benefits (low in fat, high in fiber, etc), food sourcing (all-natural, organic, etc), or production methods (non-GMO, etc).

Research

To support these claims, scientific research is often conducted. This research often involves laboratory studies, clinical trials, nutritional analyses, and other forms of scientific investigation. If a product claims to be heart-healthy, studies may be conducted to demonstrate its impact on heart health.

Gathering & Analyzing Data

Data is collected and analyzed during the research process to provide evidence for the claim. This data may include nutritional content, ingredient analysis, health effects, consumer preferences, and more.

Legal and Regulatory Reviews

Companies must ensure that their claims comply with applicable laws and regulations. Food regulatory authorities, such as the U.S. Food and Drug Administration (FDA), have specific requirements for food labeling and advertising claims. Most companies consult with legal experts to navigate these regulations.

Third-Party Verification

In some cases, companies seek third-party verification or certification for their claims. Independent organizations or certification bodies may assess and verify that the product meets certain standards or criteria. A good example is the USDA Organic label is a third-party certification for organic products.

Documentation and Records

It is essential to maintain thorough documentation of the research, testing, and verification processes. This documentation can be crucial in case of legal challenges or regulatory inquiries.

Finalize Labeling and Marketing

Once claims are substantiated and verified, they can be used in product labeling, advertising, and marketing materials. Companies must ensure that these claims are clearly and accurately communicated to consumers.

Legitimate Consumer Education

In addition to making claims, companies often provide information to educate consumers about the benefits and attributes of their products. This can include nutritional facts, ingredient lists, and explanations of specific claims.

Regular Monitoring and Compliance

Even after a product is launched, companies must monitor its compliance with claims and regulations. Regular testing and quality control measures help ensure that the product continues to meet its claimed standards.

Prepare for Future Challenges

If consumers or regulatory agencies raise concerns or challenges about a claim, the company must be prepared to address them promptly and transparently. This may involve further research or modifications to the claim.

The Importance of Substantiating Claims

Substantiating claims in the food industry is a rigorous process designed to protect consumers from false or misleading information. The process is also designed to allow companies to communicate the genuine benefits and qualities of their products. Claim substantiation is subject to oversight by regulatory authorities and may involve legal consequences if claims are found to be unsubstantiated or misleading.

The food industry claims substantiation process is designed to protect both consumers and producers.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.

The post Substantiating Food Industry Claims appeared first on Biofortis Research.

GMO Usage

Genetically Modified Organisms (GMOs) are used in food primarily to introduce specific traits or characteristics into crops and agricultural products that can benefit both producers and consumers. These genetic modifications are made through biotechnology techniques, such as genetic engineering. There are many reasons GMOs are used in the food industry:

• Increased Crop Yield
• Pest Resistance
• Chemical Tolerance (herbicides, fertilizers, etc)
• Crop Disease Resistance
• Improved Nutritional Content
• Extended Shelf Life
• Reduced Allergens
• Crop Adaptation

The use of GMOs in food has been a subject of debate and controversy due to concerns about their safety, potential environmental impacts, and labeling. Some countries have implemented regulations to govern the cultivation and sale of GMOs, and consumer preferences vary regarding GMO-containing products. As a result, the use of GMOs in food production is a complex and highly regulated issue.

The Importance of GMO Testing

There are several important reasons for conducting GMO testing. GMOs are still being researched and little is known about the long-term consequences of heavy use in food. Some of the most important reasons GMO testing is essential include:

GMO Regulatory Compliance

Many countries have regulations in place that require the labeling of food products containing GMO ingredients. GMO testing helps ensure compliance with these regulations and provides consumers with information about the presence of GMOs in the products they buy.

GMO Product Quality Control

GMO testing is used by food manufacturers and producers to verify the accuracy of labeling claims and to maintain the quality and consistency of their products.

Supply Chain Information

Companies involved in the production and distribution of agricultural products use GMO testing to track and manage the presence of GMOs in their supply chains.

Standardized Research and Development

Scientists and researchers use GMO testing to study the characteristics and effects of genetically modified organisms, both in the laboratory and in the field.

GMO Testing Methodology

GMO testing is conducted in many different ways. Testing procedures can vary by industry. Some of the most common methods for GMO testing include:

Polymerase Chain Reaction (PCR) Testing

PCR is a molecular biology technique that amplifies specific DNA sequences. In GMO testing, PCR can be used to detect and quantify the presence of DNA sequences that are specific to genetically modified organisms.

Enzyme-Linked Immunosorbent Assay (ELISA) Testing

ELISA is an immunological assay that detects the presence of specific proteins. In GMO testing, it can be used to detect and quantify the expression of genetically modified proteins.

DNA Microarray Testing

DNA microarrays are tools that allow the simultaneous analysis of thousands of DNA sequences. They can be used to identify and characterize the genetic makeup of a sample, including the presence of GMOs.

Next-Generation Sequencing (NGS) Testing

NGS technologies can provide detailed genetic information about an organism, making them useful for identifying GMOs and their genetic modifications.

GMO testing plays a crucial role in ensuring food safety, transparency, and compliance with regulations related to genetically modified organisms. It allows consumers to make informed choices about the products they consume and helps maintain the integrity of the food supply chain.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.

Learn about the Non-GMO food Movement at Merieux Nutrisciences.

The post The Food Industry & Non-GMO Testing appeared first on Biofortis Research.