Posted in IVD by Thomas Klein on January 23, 2015
In 2014, many of the big pharmaceutical and medical device companies, such as Thermo Fisher, Abbott, and Roche spent billions to built up capacities in molecular diagnostics. Siemens CEO Kaeser even assumes that there is a ‘Paradigm shift’ towards molecular diagnostics within diagnostics. The technology is seen as to promote the new era of personalized medicine.
“Companion diagnostics will become more routine. Healthcare providers and Pharma need the tools that can allow them to stratify patients into those that stand to benefit from a particular treatment [or] product and those who don’t,” Jim Greaves, head of marketing and business development of the molecular diagnostics start-up Renishaw Diagnostics Ltd , told EMDT.
“I think personalised medicine is coming and can see the benefits especially with antimicrobial resistance being such an issue now and for the future. Cost will be a factor and I’d imagine it will be for the expensive medicines and/or cases where resistance is growing,” said Duncan Graham, professor at the FRSE Centre for Molecular Nanometrology Department of Pure and Applied Chemistry at the University of Strathclyde and co-founder of Renishaw Diagnostics. “It may also allow patients to be monitored to see if they need to continue with long term medication or if that can be reduced or removed.”
Graham, who will give a presentation on ‘Molecular Diagnostic Product Development’ at this year’s Medtec UK conference, is convinced that the impact of the technology will be significant not only for medical technology but for the entire healthcare sector. “[…] yes, I do think pharma and diagnostics could converge in the future, but suspect economics will dictate this rather than medical efficiencies!”
While the prospects for companies active in that area might be bright, regulatory compliance is the major challenge. “We’ve had the assay working for some time, but getting all the necessary paperwork together, has been a lot more effort than I’d ever imagined, ” admits Graham whose company is working on molecular diagnostics assays that have the ability to test for multiple infectious agents simultaneously based on specific DNA analysis and a read out using surface enhanced Raman scattering (SERS).
Greaves says that the financial burden and resources required to conduct the clinical evaluations and to obtain ISO 13485 certification to demonstrate product quality are significant. “Designing studies to evaluate performance when no gold standard method exists or when the performance of current methods is poor,” is a key challenge for Greaves as well as the forthcoming regulatory changes to the medical device directives which will likely mean increased regulatory scrutiny of IVDs.
“Reimbursement is also a difficult topic, with significant differences between countries, even within the EU. The legislation is very complex and we have engaged a specialist consultancy in Germany, one of our first target markets, to help guide us through the process,” Greaves said. “In the UK, the NHS has a reputation for being a difficult customer to win over and the combination of tight financial constraints and ‘silo’ budgets compound this. For example, many molecular diagnostic tests are more expensive than ‘traditional’ laboratory tests, but they may offer savings in reduced costs of patient care and improved outcomes. But these savings are not visible to the manager of the laboratory budget and it can be difficult for the hospital to account for the wider benefits.”
In comparison to more ‘mature’ technology areas in diagnostics where progress is relatively slow, the frequency of breakthrough innovations in molecular diagnostics is still high. The following years will likely see new developments that will drive the costs down and improve outcomes. For Graham, the key technology trend within molecular diagnostics will be closed tube and minimal sampling with quantitative detection of multiple species at ultra low concentrations.
Jim Greaves thinks that Next Generation Sequencing (NGS) will probably become the gold standard test. “[…] but until the cost and time to result align with the payers’ expectations, there remains a place [for] high-multiplexed, higher throughput molecular diagnostics, as well as point of care (PoC) diagnostics.”
“I think it is also worthwhile mentioning the shift towards deskilling laboratory based diagnostics through the introduction of more sample-to-result style platforms. The advances in microfluidics has allowed the development of some clever cartridge based systems for this purpose,” Greaves told EMDT. “However, these systems are currently very expensive and their introduction requires a tricky equation to be balanced between the time/resource cost savings and the system price and cost per test. Their current applications tend to fit best at PoC where rapid diagnosis is critical.”