As unfortunate as they are, global catastrophes are often accelerators for change. Smartphones, for example, use advanced technology like satellite maps or high-resolution video cameras, initially developed for war purposes.
Recently, the world was hit by another catastrophe: the COVID-19 pandemic. Lockdowns, hospital overflows, mass layoffs, lost lives; billions of people had their world turned upside down. More than two years later, people are still healing from the pandemic. Although we cannot downplay the hurt it has caused many, we can also acknowledge the good that came out of it.
Before the pandemic, personalised testing was almost a myth. Although it existed, we reserved it for specific situations. As the coronavirus spread, we had to come up with solutions to quickly identify the infected individuals in an effort to contain the virus.
Companies quickly developed personal and private diagnostic solutions for people to self-test. Today, as the worse of the pandemic is behind us, this infrastructure is still in place, representing an opportunity for other companies who want to offer personalised medicine for domestic use.
What is personalised medicine?
Personalised medicine, also called precision medicine, is a type of medical care that offers treatment customised to the individual patient. In other words, we consider the individual characteristics of the person to choose the most effective treatment.
Personalised prescribing is an example of personalised medicine. It uses pharmacogenomic testing to establish a person's genetic profile and prescribe the most effective medication for them. Based on Genomics England, the genetic variations from person to person can affect how they respond to a particular medicine, the dose they need, and their risk of suffering from serious side effects. By using this information, it is more likely that each patient will receive the most effective medicine, at the best dose, the very first time. So far, researchers have found more than 40 medicines for which genetics can play a role in tolerance and effectiveness (1).
In the UK, the British Pharmacological Society and the Royal College of Physicians advocated for the full integration of personalised prescribing into the healthcare system. They believe it is the best way to provide NHS patients with safe and effective medicine.
Improving the quality and the efficacy of drugs with personalised medicine
Despite the colossal amount of money invested in drug development, it is not a very successful enterprise. Indeed, 9 out of 10 drugs fail clinical trial testing. We can attribute these failures to one of four reasons: lack of clinical efficacy, unmanageable side effects, poor pharmacokinetic properties, and lack of commercial interest/poor strategic planning (2).
The main reason for drug development failure is lack of clinical efficacy, with 40-50% of drugs failing for this reason. Therefore, if we could find a way to select better drug candidates, i.e. candidates that are more effective to treat the condition they are meant to treat, we could improve the success rate. Considering that the average cost of bringing a new drug to the market is $1.3 billion, there is a big financial incentive to improve the drug development process (3).
The cost of developing drugs varies based on the disease, with cancer drugs being the most expensive (3). Since developing cancer treatments is so costly, it is probably one of the areas where it is the most worth it to improve the drug development process. One way is to correctly identify the molecular target causing the disease and ensure the drug targets it (2). We can do so using a powerful gene editing tool called CRISPR for identification of potential new targets for treatment (7)
Another way to ensure the drug is successful is to select the right patients. For example, we should not administer a medication meant to target HER2-positive breast cancer cells without first checking if the patient has that particular type of cancer cell. The HER2-positive breast cancer cells medication attach to the HER2 protein and help stop the cancer cells from growing. This treatment will be unsuccessful on HER2-negative breast cancer cells and will cause unnecessary side effects.
Vivan Therapeutics provides a personalised medicine service called Personal Discovery Process (PDP). They replicate patients' genetic profiles to analyse their exome, the region of gene responsible for coding proteins. They do so to identify all the gene mutations associated with the cancerous tumour. Then, they engineer all the genetic information related to the patient's cancer into 500,000 fruit flies, so they carry same cancer mutations as in the patient. Finally, they will use the avatar flies they have created to screen over 2,000 drugs to find the most effective cancer treatment and in what combinations for that particular patient.
Improving drug development using genetic tools like CRISPR combined with technology like PDP can increase the quality and efficacy of cancer drugs, enabling us to fight the disease better.
Fighting antibiotic resistance with personalised medicine
Bacterial infections are another condition for which we need targeted medications to prevent antibiotic resistance, a growing public health threat. A recent review by the UK Government revealed concerning data as they estimate that bacterial antimicrobial resistance (AMR) could kill as many as ten million people yearly by 2050 (4).
Despite developing more potent antibiotics, bacterial resistance continues to be an issue. Pathogens like methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae are becoming more common. This situation is problematic because those resistant bacteria are more difficult to treat and require intense treatment. The worry is that they continue to evolve and acquire resistance, making treatment impossible.
The main cause of the antibiotic resistance crisis is attributed to antibiotic overuse and misuse, as well as lack of new drug development (5). Coordinated efforts are greatly required to set new policies therefore, prescribe antibiotics only when indicated and also implant new research studies. Moreover, the prescribed medication should be as specific as possible to target the pathogen responsible for the infection. Finally, healthcare practitioners must select the appropriate dose and treatment duration, as these factors can also play a role in bacterial resistance (5).
Companies like DNAe decided to tackle the problem of bacterial antimicrobial resistance. They developed the LiDia-SEQ Platform, a hospital-friendly system that can accurately diagnose infectious diseases in as little as 3-4 hours. They extract the microbial DNA sequence information using the patient's whole blood specimens. This way, they can identify the exact pathogen causing the infection. This information improves antibiotic use because healthcare professionals can select the best antibiotic and dose for that bacterium.
Is personalised testing invasive?
Personalised testing would not be feasible if it was terribly invasive for patients. Although the level of invasiveness varies depending on what you need to test for, a simple blood test is often sufficient, sometimes even just a few drops. Needles can be uncomfortable, but for most, a few blood drops are not bad compared to a rapid lateral flow test.
With time, personalised testing will likely become even less invasive. Indeed, technology is constantly improving, and we can do a lot with very little blood.
Have you heard of Elizabeth Holmes and her company Theranos before? Her full story is discussed on The Dropout Podcast. Although her company was a scam, many recognise that her original idea was brilliant: using a few blood drops to run tests and diagnose conditions like cancer or autoimmune disorders.
It is unsure if we will one day be able to develop a test like the one Theranos promised, but some are getting close.
ZIO Health has developed proprietary biosensor technology, bringing hospital lab testing to the point of care to improve patient outcomes. Using this pocket-sized technology, they have developed a portable therapeutic drug monitoring device - A powerful tool for dose individualisation to enhance drug efficacy. The therapeutic drug monitoring device quantitatively tests medication levels at the point-of-care. Using machine learning algorithms, they combine the real-time test results with the patients' unique profile to accurately provide dosing information, significantly reducing toxic side effects & improving outcomes. Monitoring certain medications' therapeutic levels is important, especially when they have a narrow therapeutic target range or significant pharmacokinetic variability which often leads to severe toxicity or ineffective drug treatment. ZiO Health's POC device maximises the clinical benefit of a medication while minimising its side effects.
Personalised testing: the key to overcoming the barriers to healthcare access?
The healthcare system is overflowing, making it difficult for patients to get the care they need. Personalised medicine and testing could be part of the solution.
The urgency of the COVID-19 pandemic resulted in a rapid acceleration of personalised testing technology. The healthcare industry and its patients experienced personalised medicine, and they want more, an opportunity for biotech companies and their investors.
There is a lot of interest in applying personalised medicine principles and technology to all the fields of medicine. For example, telehealth has become a popular option for many patients and doctors. They prefer meeting virtually as they find it more practical and less time-consuming.
Companies like Chronomics can facilitate the transition to telehealth with their diagnostic tool. They analyse patients' biomarkers to provide invaluable insight into their body's biological processes. With this information, providers can tailor their care plans to each patient. For example, they can improve their sleep, create personalised diets, and customise their skincare regimen.
For personalised testing to work, we must find solutions for testing facilities. Indeed, there is no point in sending patients to hospitals to get their blood tests done if the goal is to reduce hospital visits. OpenCell may have found the solution: testing in shipping containers using portable equipment. OpenCell implemented these labs quickly and processed 598,155 samples in about a year (6). Their portable labs were invaluable in controlling the COVID-19 pandemic.
We could implement such facilities for other personalised testing purposes. Hypothetically, patients could visit the container laboratory closest to their home to give their blood samples. The tests would be sent to the biotech company responsible for the analysis, which would then input the results into its smartphone app for the physicians and patients to access.
The Take-Home Message
Although many advocated for more personalised medicine before the COVID-19 pandemic, it was not commonly done. The coronavirus hit the world by storm in 2020, creating the need for quick, personalised testing to limit infection. It is recognised that during the COVID-19 pandemic, the genetic profile of individual patients is one of the leading contributors to drug effectiveness. Therefore, the challenges faced during the pandemic made the health care system understand and acknowledge the importance of personalised medicine (8). There is now interest and a will to continue using personalised medicine for other purposes, like cancer treatment, appropriate antibiotic use, and virtual primary care, an opportunity for biotech companies and their investors.
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- Genomics England: New report calls for personalised testing for safety and effectiveness of common medicines throughout the NHS
- The Conversation: 90% of drugs fail clinical trials – here’s one way researchers can select better drug candidates
- The Lancet: Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis
- LIEBERMAN, JAY M. MD. Appropriate antibiotic use and why it is important: the challenges of bacterial resistance. The Pediatric Infectious Disease Journal: December 2003 - Volume 22 - Issue 12 - p 1143-1151 doi: 10.1097/01.inf.0000101851.57263.63
- Rapid genome surveillance of SARS-CoV-2 and study of risk factors using shipping container laboratories and portable DNA sequencing technology. Sara Farahi Bilooei et al. medRxiv 2022.02.25.22271277; doi: https://doi.org/10.1101/2022.02.25.22271277
- Bin Liu, Ali Saber, Hidde J. Haisma, CRISPR/Cas9: a powerful tool for identification of new targets for cancer treatment, Drug Discovery Today, Volume 24, Issue 4, 2019, Pages 955-970
- Visvikis-Siest Sophie et al, Milestones in Personalized Medicine: From the Ancient Time to Nowadays—the Provocation of COVID-19, Frontiers in Genetics. Volume 11, 2020