The Eastern Pathology Alliance (EPA) has announced that it is to offer Hepatitis C genotyping testing to the wider NHS nationally leveraging its investment in next generation sequencing assays.
Founded in 2012, the EPA has become a centre of excellence for pathology – particularly virology – providing centralised laboratory medicine for the Norfolk and Waveney region. It has selected state of the art equipment from Vela Diagnostics, which incorporates Ion Torrent semiconductor sequencing to provide rapid turnaround of results for clinicians and their patients. It is currently the only laboratory in the UK to put this kind of a high-tech solution into routine use.
Aimed at other acute NHS Trusts, CCGs and private healthcare providers, the new service will comprise a whole package involving fast testing, clinical interpretation, along with guidance and advice about drug selection. Pricing will be based on a per test fee.
HCV infections a major public health threat in the UK
Mainly affecting the liver, Hepatitis C is the only blood born virus, which is a curable infection with success rates of between 92-95%. Although a national data set is unavailable, most recent estimates by Public Health England (PHE) show that 160,000 people are living with chronic Hepatitis C virus infections in the UK.
The use of next generation sequencing assays enables detailed analysis of the genetic material of the Hepatitis C virus (HCV) to confirm its strain – predominantly genotypes 1 and 3 in the UK – and the determination of resistance mutations. This information is crucially important for clinicians so they can then prescribe the optimum mix of drugs to treat the virus.
Dr Samir Dervisevic, a Consultant Virologist and the Clinical Lead for Virology at the EPA’s Microbiology Department explains, “In May 2016, the UK signed up to the World Health Organization strategy on viral hepatitis, which commits participating countries to the elimination of Hepatitis C virus as a major public health threat by 2030. In England, HCV treatment is centrally funded and the NHS England direct acting antiviral (DAA) treatment programme continues to be rolled out with several medications authorised. Given this, ascertaining the genotype strain before treatment starts is recommended especially as the duration of treatment among other factors depends on the virus genotype.”
Samples collected from patients in Norfolk used to be referred to a private laboratory for HCV genotyping. When drugs were prescribed but the treatment failed – which could be due to virus resistance to a particular directly acting antiviral drug – blood samples were then sent to the Reference Laboratory in London for resistance profiling. Due to the turnaround time, some patients had to wait a prolonged period in order to receive the results and be re-treated.
This time-consuming process – often taking months - slowed down the effective delivery of clinical services. Furthermore, samples were split, testing was overly costly and patients experienced significant distress.
Dr Dervisevic adds, “We’ve opted out of referring samples to these two external laboratories and instead invested in the latest cutting-edge solution of our own, which gives us automated workflow from sample to results within just two days so that patients get the right treatment fast. We’re now happy to offer our clinical colleagues access to this modern technology so that they receive a quick, accurate and reliable diagnostic service, combined with clinical backup and expertise.”
New HCV testing enabled by vendor neutral managed services
With a small physical footprint, the compact Vela Diagnostics technology – a combination of a Sentosa SQ Genotyping Assay and Sentosa ST401 instrument unit - is perfect for use in a busy space-constrained laboratory setting. The EPA has installed both, working in close collaboration with its established vendor neutral managed services partner, Genmed.
The use of a managed services contract (MSC) has meant that the EPA has been able to introduce the new test equipment rapidly and benefit from a pay-to-use approach.
Reenesh Prakash, EPA microbiology network manager explains, “The contract we’ve signed is an interesting one. We've agreed with Genmed and Vela Diagnostics the volume of work we’ll deliver over time and adopted a tax efficient MSC where we’re charged per reportable test.”
An MSC provides the EPA with other benefits also. First, it is able to reclaim VAT to give the organisation a 20% budget boost. Genmed provides all administrative support related to arranging equipment maintenance and the ordering of consumables and it minimises operational risk as Genmed takes responsibility for equipment uptime with a SLA set at 90% availability.