Biomarkers in patient selection point towards Personalized medicine. Different individual responds differently to different treatments which results in therapy’s poor outcomes. For stratification of different patients according to their treatment response molecular profiling of the individual is done. This stratification diagnostic indicates towards different Biomarkers that are identified in an individual in response to distinct treatments. With these markers identifying patients that are more likely to respond favorably to a given therapy, determining the predisposition to disease at the population level, the drug doses and the deliver time is optimized.

Biomarkers have several uses in pharmaceutical R & D. With the recent introduction of high performance instrumentation, protein and gene arrays and bioinformatics, clinical decisions like Drug development and choosing type of treatment can be made efficiently. However, there is a lack of valid biomarkers to increase the drug development from pre-clinical through all levels of clinical studies. Biomarker in Drug Discovery can also lead to development of Personalized Medicines.

Neurological biomarkers are present in CSF (cerebral spinal fluid), but hardly or at imperceptible levels in blood. The brain is carefully shielded by the blood–brain barrier, which protects it from damaging elements flowing in the bloodstream. Sadly for diagnostic purposes, this barricade has also made the brain’s chemistry unreachable to a fitting blood test. Neurological biomarkers can be studied using CSF, but this requires an incursive and hurting lumbar puncture technique.

Biomarkers that can monitor various immune system diseases like autoimmunity, immunodeficiency, cancer, allergy and infections are called Immunological biomarker. As the immune system interacts with every other system in the body it plays a very important role in Biomarker discovery.  Immunological biomarker such as miRNA a serum Biomarkers can give information regarding immune response of a body under normal or abnormal conditions.

Whenever the Heart muscles get damaged or are under some kind of stress it releases components (like proteins) in the blood. Presence of these components in blood can indicate your heart’s condition. These molecules are called Cardiovascular Biomarkers. Measuring the Biomarkers can help us monitor presence of cardiac ischemia, Acute Coronary Syndrome or the risk of having these conditions.

To get the coverage and reimbursement remained a primary hurdle towards the adoption of new Biomarker testes for d3edliest diseases like cancer. If certain tests are not accepted by the regulatory bodies, and insurance companies,  it highly impacts the entrant of new Biomarker tests. The Centers for Medicare & Medicaid Services identified only 65 tests under the reimbursement category. Any test beyond that although useful may not reimburse hence creates a huge challenge.  

Personalized medicine uses an individual’s genetic profile to optimize decisions made regarding prevention, diagnosis, and medical treatment of diseases. The goal is to provide accurate therapy to the correct patient at the right time. Genomic data of an individual is the base of personalized medicine. Personalized medicine works by separating different population groups according to their molecular model. Different Biomarkers have been identified in an individual associated with different therapeutic response. Using these markers can results in complete understanding of drug doses, timing of treatment and type of treatment to be given to individual patients.

Medical imagining for clinical decision making has been very crucial over the past decades. In medical images like X-ray, CT and MRI the trait of the image that shows the condition of health and disease of the patient is called Imaging Biomarkers. A lesion, tumor etc. on the body part that can be noticed in the medical image and can cause suspicion about certain disorder is an Imaging Biomarker itself.

The use of Biomarkers in drug development has clinical benefits that lie in evaluating therapeutic response or in monitoring and diagnosing the activity of diseases. The discovery and validation Biomarkers serve as new surrogate endpoints in initial stage of drug trials. The components of the biomarker development process include qualification, discovery, verification, research assay optimization, commercialization and clinical validation. For development and discovery of biomarker omics techniques like metabolomics, Transcriptomics, proteomics, and genomics are used and for validation of Biomarkers computational biology, profiling techniques, data mining methods and microarray data analysis can be utilized.

Though the therapeutic effects of targeted drugs treating various cancers and other diseases are promising still there is limitation in their clinical success. The factors limiting the clinical success include both primary and acquired drug resistance including unpredictable side effects. Hence there are various researches are in progress to discover new Biomarkers for various disease starting from autoimmune disorders to cardiovascular and Cancers. 

There are many circulating components found in biofluid but the one gaining significant attention is Exosomes. Exosomes are extracellular vesicles released from cells when an intermediate endocytic compartment fuses with the plasma membrane. It is found in almost all biological fluids like blood, urine, saliva, serum, breast milk etc. These acts as a mediator of cell to cell communication as they transfer bioactive molecules like lipids, nucleic acids, proteins etc. to the other cells.  As they carry important molecular information like nucleic acid and protein they show the source of cell and indicate if there is any presence of abnormal cells, hence acting as a Biomarker.

Genetic-based Biomarkers are nothing but DNA or sequence based Biomarkers that can provide genetic information of the person. Next-Generation Sequencing has allowed researchers to sequence individual genomes and compare several mutations with specific diseases. Cancer being an inherent disease of the genome, it is expected of NGS technology to be applied in the area cancer for better understanding of carcinogenesis. NGS can also be used for analysis and validation of sequence based biomarker. It further assists in development of a more precise Personalized medicine.

Efficiency of mobile health or mhealth techniques in collecting, integrating, analyzing health related data has given rise to a cost and time effective sensor called Digital Biomarkers. Digital Biomarkers have ascended from Patient-facing devices. These uses machine learning techniques and smartphone sensing technologies to monitor users’ health status such as heart rate and blood pressure. They can also be used to check their mental health by collecting and analyzing data regarding mobile phone usage patterns, mobility and communication. Their aim is to reduce the damage cause by computer models and wearable sensors and to make clinical trials more precise.