Prior to and only enhanced by the pandemic, in vitro analysis of biological specimens like tissue samples or blood amongst others plays a huge role in guiding accurate diagnosis & subsequent therapy. When used in tandem with a specific therapeutic drug or medicine and relying on the presence or absence of a predictive biomarker, such IVD are known as Companion Diagnostics (CDx).
A companion diagnostic is essentially a medical device while helps differentiate patients between responders & non responders with reference to a certain drug or therapy. For example, a ‘CDx’ may allow doctors to identify whether a cancer patient’s tumor has had a specific gene change or a reduction when a specific therapy was administered. The test may also showcase lack of efficacy or any potential side effects if that method of treatment continues.
Effectively, companion diagnostics help in:
- identifying patients who could most likely benefit from a certain kind of therapy/treatment.
- identifying patients who could be adversely affected or stand at risk of life-threatening side effects due to a specific kind of therapeutic product.
- monitoring the ongoing response to therapy in order to efficiently alter or adjust the dosage to achieve improved benefit.
We can clearly understand that purely based off their ‘modus operandi’, companion diagnostics are paving the way forward for personalized & precision medicine with specifically targeted therapies, tailored according to an individual’s genetic makeup.
A number of benefits exist for the entirety of the healthcare eco-system in adopting, utilizing & pushing forward the use of companion diagnostics.
- A better understanding of genetic characteristics and/or biomarkers of a patient can initiate standard procedures of administering ‘the right drug, at the right dosage for the right person & most importantly at the right time’.
- CDx tests allow for early detection and screening of chronic illnesses.
- Limit ineffective usage of crucial medical care while optimising patient benefits.
- Several entities stand to benefit apart from the patient who stands as the number one priority. Pharmaceutical & diagnostic companies working in collaboration with drug developers to create a therapy linked with a particular CDx shall reap huge profits if the combination is useful & approved.
- Reduction is future side effects of drugs on patients who are not suited for a specific form of therapy/treatment.
- Highly touted as the next best thing for oncology, chronic musculoskeletal, cardiovascular, neuropathic and metabolic disorders have also hugely benefited from the ongoing research on CDx and biomarker-based therapies.
While game-changing technologies & innovations give rise to novel pathways like the use of companion diagnostics, some inherent challenges exist as well.
- CDx tests can take up to 5 years to develop at an estimated cost anywhere between $15 to $30 million & the pharmaceutical company must also develop & market the combinational drug simultaneously with the future still hazy at different point in the lifecycle.
- A lengthy process which involves several key stages means it takes a toll on those developing these therapies. 6 key stages exist as follows with no guarantee of the an approved or working end product.
- Scientific validation -> Analytical validation -> Clinical validation -> Demonstration of clinical utility -> Marketing authorization -> Marketing & Post-Commercialization.
- Oncology is the main field promoting the growth of biomarker based CDx tests but extremely high costs of cancer immunotherapies could render patients w/o any options but to resort to other means. CAR T-cell therapies cost well over hundreds of thousands of dollars and switching treatment based od CDx could hamper the progress of the market.
- A lack of awareness is omnipresent around the world regarding diagnostics and clinical trials. The eyes of patient & even healthcare professionals must be opened to the potential gains using CDx.
- Most importantly, the increasingly stringent regulatory requirements for IVD’s means scientific, clinical & analytical validity will be frequently tested & reconfirmed making it harder to get or maintain the stamp of approval.
Explore & get up to speed on the future roadmap, trends & challenges within the CDx Industry at the 7th Annual MarketsandMarkets Biomarker and Companion Diagnostics Conference on the 16th-17th June 2022 at San Diego, USA.