Course unit details:
Role of Diagnostics in Medicine

Course unit fact file
Unit code BIOL31832
Credit rating 10
Unit level Level 3
Teaching period(s) Semester 2
Offered by School of Biological Sciences
Available as a free choice unit? No

Overview

This new lecture unit will be delivered entirely by senior scientists from QIAGEN from their Global Development and Molecular Diagnostics division. Students will learn about current diagnostic concepts as well as how to translate advanced molecular technologies into future diagnostic techniques - as explained by commercial scientists working at the cutting edge of this process. The unit will cover both the science and the regulatory requirements necessary for such developments. Though running conventionally (i.e. in Stopford, with Podcasts, Blackboard and an internal Unit Coordinator) the unit is otherwise a unique and extremely exciting opportunity to hear directly from very senior scientists working at a major international Life Sciences company. This unit should be of special interest to the Biomedical Sciences (and related) and Biotechnology (and related) programmes as well as to those students doing an Enterprise project.

Pre/co-requisites

None. Helpful units include:BIOL21351: Molecules & Cells in Human DiseaseBIOL20902: Clinical Sciences RSM

Aims

To explore current approaches in medical diagnostics, as well as how to develop and obtain approval for future diagnostic techniques. To consider Translational Medicine and its possible impact on human healthcare.

Syllabus

•       Introduction to Medical DiagnosticsWhy is it needed? Overview of existing diagnostics:Patient interview (symptoms);In vivo imaging e.g. X-ray, PET, MRI; In vitro sampling (Blood, biopsy etc)Diagnostics performance - Sensitivity, Specificity, Precision.Positive & negative predictive values (PPV, NPV) •       Molecular Diagnostic (MDx) TechnologiesDNA-based e.g. (q)PCR, Sequencing (Sanger, Pyro, Next Gen/NGS)Syndromic testingProtein-based e.g. ELISA, ImmunohistochemistryMetabolite-based e.g. Chromatography (LC-MS)Diagnostic devices and formats; Companion diagnostics •       Medical Diagnostics - Regulatory Environments and RequirementsWhy regulation is necessary. Regulatory agencies in EU/US/CN/JP/AUSApproval process and requirements.Overview of US regulations - ASR, CLIA, 510k, PMA.Example of regulatory approval process for device and assay (FDA/CE documents)Typical development process and documentation requirementsPost-launch surveillanceImpact of regulatory processes - positive and negative on healthcare •       Translational Medicine OverviewRationale: translate new discoveries into clinical practice - improve human health. Definition (three pillars: benchside, bedside and community).Combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies.Future of Diagnostic MedicineMechanisms supporting this: Government, Commercial, Programs and organizations supporting translational science

Assessment methods

Method Weight
Other 20%
Written exam 80%

800 word essay – 20% On campus written examination (80%), comprising 1 essay from a choice of 2.

Feedback methods

Blackboard Discussion Board - checked regularly by Unit Coordinator.

Recommended reading

There are no specific textbooks for this unit.

Study hours

Scheduled activity hours
Assessment written exam 2
Lectures 17
Independent study hours
Independent study 81

Teaching staff

Staff member Role
Nicola High Unit coordinator

Fees and funding

Fees

Tuition fees for home students will be £10,050 for the 2027/28 academic year. In England and Wales, tuition fees for home undergraduate students are subject to the Government fee cap, which the Government has announced will be £10,050 for the 2027/28 academic year.

Government policy is to increase the fee cap on an annual basis to reflect inflation (i.e. increasing costs), and the tuition fee home students pay in subsequent academic years will reflect any increases in the Government fee cap (which we will communicate to you as soon as we can in advance of the relevant academic year).

Tuition fees for international students will be £38,000 for the 2027/28 academic year. For subsequent academic years, the University reserves the right to increase the tuition fee by up to 7% each year, including to reflect rising costs associated with delivering our education and wider student experience.

For general information please see the undergraduate finance pages.

Tuition fees are considerably lower for your placement year. Please see the fees page for full details.

Policy on additional costs

All students should normally be able to complete their programme of study without incurring additional study costs over and above the tuition fee for that programme. Any unavoidable additional compulsory costs totalling more than 1% of the annual home undergraduate fee per annum, regardless of whether the programme in question is undergraduate or postgraduate taught, will be made clear to you at the point of application. Further information can be found in the University's Policy on additional costs incurred by students on undergraduate and postgraduate taught programmes (PDF document, 91KB).

Scholarships/sponsorships

Students participating in placements outside the UK may be able to apply for funding from the UK's Turing scheme depending on eligibility. Priority will be given to students from low income households.

Return to course details

Regulated by the Office for Students

The University of Manchester is regulated by the Office for Students (OfS). The OfS aims to help students succeed in Higher Education by ensuring they receive excellent information and guidance, get high quality education that prepares them for the future and by protecting their interests. More information can be found at the OfS website.

You can find regulations and policies relating to student life at The University of Manchester, including our Degree Regulations and Complaints Procedure, on our regulations website.