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 healthy life. For each disease expression, genetic testing plays a vital role for more precise tests through better biomarkers that closely match the actual genetic material. The promise of personalized medicine could only be through better diagnostics for the development of safer and efficient therapies.

Companion diagnostics are tests or assays IVDs intended for the extraction of a patient's genetic and genomic characteristics, which help the doctors and physicians to take better decisions for treatment of a 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 on cost regulations through the development of companion diagnostics, along with a targeted therapeutic area. For this, there has been a significant rise in the partnerships with diagnostic firms, in order to develop and produce such diagnostics, which are more targeted and effective.

How did companies visualize opportunities in therapeutics development through companion diagnostics?

The first companion diagnostics was launched in the 1980s. Its future success relates majorly on the sequencing and development of personalized medicine. In 2014, Illumina introduced a sequencing system, HiSeq X Ten, which reduced the cost of human genome sequencing to USD 1000 only and was acceptable by many families. The system could transmit almost 18000 human genomes in a year. Companion diagnostics are mainly used in oncology, to scan tumor samples from a large population. Other indications, like the treatment for cystic fibrosis, are also in focus.

The financing environment for diagnostic and research tool companies is also a key factor. Recently, Qiagen collaborated with Centogene, to increase the clinical prediction of rare diseases. Inotrem collaborated with Roche Diagnostics, to develop a companion diagnostic test in the field of septic shock. Although there have been many collaborations, the success rate has been low. For example, Gefitinib, marketed by AstraZeneca, had a disappointing outcome (the drug did not work for 90% of the patients and wave results.) Since then, there are several launches of new therapies. is FoundationOne CDx, by Foundation Medicine, a genomic profiling test for all solid tumors.

Can Companion Diagnostics be a success in the near future?

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

Some of the major hurdles for this market are high costs associated with the development of therapeutics and diagnostic tests. With the high risk of failure in clinical trials, many companies prefer partnerships to minimize their failure rate. The reimbursements issues in different countries also impede the growth of this market.