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Diagnostic Test For The Differential Diagnosis of Bipolar Disorder and Major Depressive Disorder

Periodic Reporting for period 1 - DDBSD (Diagnostic Test For The Differential Diagnosis of Bipolar Disorder and Major Depressive Disorder)

Okres sprawozdawczy: 2016-03-01 do 2016-11-30

Neuropsychiatric disorders contribute 13% to the global burden of disease and cost the European economy an estimated 789bn EUR a year. Psyomics is a Cambridge-based biotechnology start-up focussed on reducing this burden by providing scientifically-validated solutions that improve the prevention, diagnosis and treatment of psychiatric disorders. This project relates to the first clinical diagnostic that we intend to bring to market, a test to improve the differential diagnosis of bipolar disorder (BD) and major depressive disorder (MDD).
Psyomics conducted this feasibility study in order to assess the commercial viability of the project. Specifically, the study aimed to investigate and evaluate four key areas: market access and reimbursement; technical feasibility; operational feasibility; and regulatory requirements.
The feasibility study has been conducted over 9 months. The market access, regulatory and technical studies were undertaken in parallel from the start date of the project. The outputs of these first three studies in terms of key dates, expected sales figures and expected price then fed into the operational and financial feasibility studies. The operational study assessed the logistical and human resource required to achieve the milestones outlined in the first three sections and the financial study attributed costs to these resources and determined the overall return on investment for the project.
Summary of findings:
Market Feasibility
The market feasibility investigation identified the most advantageous markets for the commercialisation of the Psyomics test, quantified the market potential in those countries and indicated an initial market access strategy for those selected countries.
The results have indicated that Psyomics should focus on Germany, France and the UK for initial commercialisation, branching out to additional markets such as Spain and Italy through licencing partnerships only after the test has been established in these core markets.
Quantification of the market size involved a thorough survey of stakeholders in the sector and a literature review. In both cases, we could identify clear unmet need and cost savings to the healthcare system. This work formed the basis of pricing strategy and initial health economic analysis. Following on from this work, Psyomics will commission an independent market access and health economic consultation to gain further independent validation to support future investment rounds.

Regulatory Feasibility
Although conducted in parallel with the other work packages, the regulatory feasibly was core to the project objectives. As the product and market access strategy developed, the regulatory approach was refined to give an integrated product strategy. As a result of this project, Psyomics now is able to implement the regulatory approach early in the product development pipeline and has a clear understanding of the resource required to comply with the regulatory standards as the product is developed. This will reduce time to market and avoid greater costs if implemented at a later stage.
Psyomics have also begun the process of compiling the technical documentation for ISO 13485 certification for the company in Q2 2017 and are using this framework in the initial phases of development for the bipolar/ MDD diagnostic. The project would be initially CE marked as a Class I medical device, moving to a Class IIa as the evidence builds for diagnosis vs. risk identification.
In addition, the CE marked product will now be a risk based algorithm which will combine both biomarker results, which can be outsourced to an accredited CPA laboratory, and a primary digital test. This allows initial development and product launch within the company and a route to expand via licencing with partner European laboratories. During this project, Psyomics also developed a CE marked blood collection kit which was used as part of the technical feasibility.
In order to achieve full regulatory approval for the diagnostic in 2019 Psyomics will need to expand its regulatory affairs team to an estimated 4 full time employees.
Technical Feasibility
The technical feasibility study involved discussions with key stakeholders to define key characteristics of the target product profile (TPP). The process of refining the TPP was highly impactful for Psyomics. Through the process it became clear that a two-stage test model would be beneficial to both payers and patients. Psyomics therefore adapted the profile to incorporate an initial risk screen using a digital question-based approach to identify patients at higher risk of bipolar disorder prior to utilisation of the blood-based diagnostic. Only patients at increased BD risk are therefore advised to take the blood-based diagnostic test. This approach improves cost-savings, predictive-performance and clinician acceptability. It was therefore a key finding of the technical feasibility study.
The technical investigation has also identified and designed the two trials that will be required for full regulatory approval. Further funding will be required to undertake these essential trials.
Operational & Financial Feasibility
The operational and financial feasibility study identify the need for further investment of >£3M in 2017 to support R&D requirements and the results project a strong return on this investment over the coming 10 years. Further evidence to support key assumptions in the financial model will be gathered through independent health economic and market access consultancy projects that are currently underway.
It is estimated that 33.4m people within the WHO European region suffer from major depression each year, and around 7m suffer from bipolar disorder. The separation of these two groups for appropriate treatment is very challenging because patients with an underlying bipolar disorder typically present with depressive symptoms that are indistinguishable from those of MDD. The psychiatrists surveyed by Psyomics explained that the diagnosis of BD is particularly challenging for those under 35, where symptoms of hypo(mania) are less likely to be reported. This is compounded by time-pressures on doctor’s initial assessment, meaning that these patients are typically likely to be initially diagnosed with depression and treated with antidepressants (5.21m antidepressant prescriptions were made in London last year).

Overall, around 40% of all patients with an underlying bipolar disorder are initially misdiagnosed with depression and prescribed antidepressant monotherapies (Knežević & Nedić., 2013). On average it takes over 7.5 years for the correct diagnosis to be reached (Ghaemi et al., 1999, and 2012) (BipolarUK survey of 706 patients)

This misdiagnosis has detrimental consequences for both the individual patients and the healthcare system. Antidepressant monotherapies are ineffective in the treatment of BD and furthermore they are known to lead to an increased risk of anti-depressant induced mania, rapid cycling and suicide attempts among these patients, all of which lead to an increased rate of hospitalisation and healthcare costs. For instance, Yerevanian et al., 2007 reported that the rate of suicide events was over 7 times higher in BD patients receiving an antidepressant monotherapy in comparison to those receiving mood stabilisers.

Psyomics will reduce this rate of misdiagnosis by providing doctors and psychiatrists with a simple two stage blood-spot diagnostic that will indicate the risk of bipolar disorder vs MDD and therefore the most appropriate treatment strategy and clinical care pathway for that patient. The diagnostic will be based on a biomarker panel of 20 proteins that has been recently discovered by the Cambridge Centre for Neuropsychiatric Research (CCNR) and published in the journal of Brain, Behaviour and Immunity (Haenisch et al., 2015). The principle investigator of the CCNR, Professor Sabine Bahn, is a co-founder of Psyomics, and Psyomics has completed a licence agreement for 6 biomarker patents from the CCNR, as well as a framework agreement, which gives Psyomics exclusive rights to future IP generated by the group. Psyomics will continue to work closely with the CCNR through validation of the identified biomarker panel and development of the diagnostic.

This feasibility study investigated the commercial viability of this project.