Advancements in molecular biology have given an insight into disease mechanisms at the genetic and molecular levels. This has led to the development of prognostic, diagnostic and therapeutic applications in medicine. Molecular diagnostics (MDx) measure genetic construction of an individual to assess any inherent tendency towards developing a disease. MDx also helps find out effective treatment options for a patient, depending on their DNA. The foundation of this science is that unusual molecules are an indication of a disease.
Benefits of Molecular Diagnostics
Earlier, cancer cells were categorized based on pathology results. This meant that the patient’s tissue sample was only screened through a microscope. However, molecular diagnostics makes use of mass spectrometry and gene chips to classify cancer. MDx is a blend of two disciplines – proteomics and genomics. A close study of the interaction between genes and proteins in cancerous cells helps develop molecular signatures. These molecular patterns are then used by clinicians to diagnose cancer. Expression patterns are made with the help of DNA microarrays, also known as gene chips.Apart from cancer and cystic fibrosis, molecular diagnostics is also used to ascertain infectious diseases, such as influenza, gonorrhea and tuberculosis. However, it is important to understand that the genetic predisposition of an individual to develop a disease does not guarantee that the person will necessarily develop that disease at some stage. Nonetheless, molecular diagnostics has revolutionized the monitoring of individuals who are more prone to certain kinds of diseases. MDx also helps in choosing specific drugs for individual patients.
Molecular Diagnostics Market Size
The US market for molecular diagnostics was estimated at $6 billion in 2011. Various reports give different figures, and consolidated data is not available. However, there is consensus among market analysts that the molecular diagnostics market will witness growth of more than 14% per annum and will reach about $11 billion by 2015. The growth will primarily be driven by an increase in chronic diseases and extensive availability of advanced tests. Emphasis on personalized medicine will also boost this market.
The Genomics and Personalized Medicine Act
Supporters of the Genomics and Personalized Medicine Act are trying their best to get a legislation passed in the US Congress to:
- Ensure patient access to personalized medicine through delivery system reforms
- Secure Medicare coverage of personalized medicine diagnostic products and services
- Incentivize personalized medicine by creating a transparent and predictable regulatory environment for products
- Establish R&D tax credits for companies developing personalized medicine drugs and diagnostics
The future of the molecular diagnostics market looks bright for the foreseeable future.