COMPANION DIAGNOSTICS: AN ABOSULUTE NECESSITY TO TARGETED THERAPEUTICS

A replacement for solid tumor biopsy could be a reality. A baby could be sequenced at birth so that the same could help to lead a healthier life. For...

A replacement for solid tumor biopsy could be a reality. A baby could be sequenced at birth so that the same could help to lead a healthier life. For each disease expression, genetic testing plays a vital role for more precise tests through better biomarkers that closely matches the actual genetic material. The promise of personalized medicine could be only through better diagnostics for development of safer and efficient therapeutics.

Companion diagnostics are tests or assays IVDs intended for extracting patient’s genetic and genomic characteristics which helps the doctors and physicians to take better decisions for treatment of the specific indication. The US FDA defines it as a medical device that identifies or determines a condition for a therapeutic product. It helps in providing the most likely and successful therapeutic intervention by getting the information through patient diagnosis. Many pharmaceutical and biotech companies have focused themselves on cost regulation using development of companion diagnostic along with a targeted therapeutic area. For this, there has been a significant rise in the partnerships with diagnostics firms to develop and produce such diagnostics which are more targeted and effective.

How companies visualized their opportunities in therapeutics development through companion diagnostics???
The first companion diagnostics were launched in the 1980s. The future success relies majorly on sequencing and development of personalized medicine. In 2014, Illumina introduced a sequencing system HiSeq X Ten that reduced the cost of human genome sequencing to USD 1000 only and was acceptable by many families. The system could transcribe almost 18000 human genomes in a year. The companion diagnostics are used mainly in oncology for scanning tumor samples from a large population. Other indications are also being in focus such as treatment for cystic fibrosis.
The financing environment for diagnostic and research tools companies also plays a key factor. Recently, Qiagen collaborated with Centogene for increasing the clinical prediction of rare diseases. Inotrem collaborated with Roche Diagnostics develop a companion diagnostic test in the field of septic shock. Though there have been many collaborations but success rate has been low. For example, gefitinib marketed by AstraZeneca had a disappointing outcome as for 90% of patients the drug did not work and gave required results. Since then there have several launches of new therapeutics. One of the recent approval of diagnostic test by FDA is FoundationOne CDx by Foundation Medicine, a genomic profiling for all solid tumors.

Could Companion Diagnostics be a success near future??

A report by a market intelligence firm has estimated a growth at a CAGR of 35% for the global companion diagnostics market and predicted the market to be worth of around USD 26 billion by 2022. The industry has seen huge growth due to increasing demand for personalized medicines and awareness among the population for the same. The rising cases of cancers globally have also been a major driving factor in this market. With companies increasing their collaborations for better biomarkers and diagnostics, there have high opportunities of its applications in indications other than cancer such as cardiovascular, neurological etc.

Some of the major hurdles in this market are high development cost in development of therapeutics and diagnostic test. With the high risk of failure in clinical trials, many companies prefer collaborations minimize their failure rate. The reimbursement issues in different countries also impede the growth of this market.

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