The current standard of tumor diagnostics is histopathology, where excisions are taken from the tissue of a diseased patient, followed by staining with dyes and visual inspection by a clinician or technician. The process is time-consuming, costly and with low sensitivity (ability to detect a condition and prevent false negatives) and specificity (ability to correctly identify those without the illness and prevent false positives). The results are subjective and qualitative, heavily dependent on the judgment of the clinician.
Spontaneous Raman (SR) scattering microscopy is a label-free and non-invasive biomedical imaging technique, giving objective and quantitative information on the tissue by measuring the detailed molecular composition without staining. SR has a proven capability to discriminate between healthy and tumour tissue and to identify the type and grade of tumour. However, the very weak Raman signal, requires up to several hours for an image, prohibiting real-time and in vivo imaging.
The Coherent Raman Scattering (CRS) microscope is based on an ultrafast graphene-enabled laser: a two-colour system using a graphene saturable absorber for both mode-locking and synchronization of two lasers operating at different wavelengths to image human tissue while differentiating by colour that which is healthy and that which is diseased ,without the use of chemical dye. The system exploits the unique optical properties of graphene including; broadband operation (covering the entire optical range), ultrafast response time (sub-picosecond) and inherent pulse synchronization in time.
There are two key features;
1. Low-cost graphene-enabled laser generating >100 mW per arm, < 10cm-1 linewidth, 2500-3300 cm-1 with picosecond pulse duration (patents submitted)
2. A laser scanning system integrated with a microscope, CRS detection chain, data processing and imaging system
Taken together, the platform will generate real time digital images of human tissue differentiating between diseased and healthy tissue by colour. The data can be further interrogated to identify chemical species present in the tissue samples; offering real time information on the status of a tumour, its stage, physical limits and response to drug therapy.
This low cost technology will enable a number of medical applications including:
The first product will be a CRS scanning microscope for use in a medical environment for diagnosis, treatment and drug therapy selection.
Together, cytopathology and histopathology systems combine to create a global market estimated at more than USD 8.6 billion in 2016. It is expected to reach USD 22.25 billion by 2023, representing a compound annual growth rate around 14 per cent. Histopathology systems made up 40 per cent of this market in 2016. The target market for histopathology will therefore reach around GBP 9 billion in 2023.
In 2016 the largest market for cytopathology/histopathology was North America where the availability of well-equipped diagnostic clinics is a key factor. Europe accounted for a substantial market share due to local presence of major market players and affordability. Asia Pacific is expected to be the fastest growing region over the forecast period, driven by government initiatives and healthcare tourism.
In some countries, the government is the major buyer, such as the NHS in the UK. In others, there are large providers backed by insurance such as in the US. Nearly all countries adopt national or supranational standards. Examples include those set by the Food and Drugs Administration in the US and the Medical Device Directives in Europe. Certification processes and existing supply relationships dominate market access.
The leading providers now also offer additional services such as digital image storage with global access and more recently, referral services where the patient may have their images anonymously examined by a second consultant for a fixed fee. These value-adding services are very popular in parts of Asia.
Users will be health care providers including laboratories and hospitals.
For healthcare providers, the benefits will include:
For pharmaceutical companies, benefits may include: