Cancer Screening Programmes

Colorectal Cancer Screening

Colorectal cancer (CRC) is preventable if caught early but it often has no symptoms early on. Colorectal cancer screening is vital as it can help detect cancer in its earliest stages, or even before it develops. Up to 90% of cases can be successfully cured if caught early with a primary health care-based CRC screening programme.

Option 1:

We can offer a combination of a FIT and Faecal Calprotectin Test, with one dry fluorescence analyser machine that both tests can be performed using. Experimental design analysed both FIT testing as well as faecal calprotectin and then determined the sensitivity, specificity and accuracy for each test and for the combination of tests. In total 658 patients were assessed – of which 286 were in the colorectal cancer arm and 372 in the adenomatous polyp arm.

Results are shown in the following table;

Detection indicator	Experimental Group (polyp / adenoma)			Experimental Group (colorectal cancer)
Detection indicator	Positive	Negative	Sensitivity	Positive	Negative	Sensitivity
Faecal calprotectin	314	58	84.4%	236	52	81.9%
FIT	252	120	67.7%	336	52	86.6%
Combined	342	30	91.9%	262	24	91.6%

As can be seen in this study, FIT testing alone was highly sensitive at detecting those patients with an established colorectal cancer. It out-performed faecal calprotectin but its sensitivity was increased by the addition of this test. In contrast, faecal calprotectin was more accurate for diagnosing pre-cancerous conditions but again, the addition of FIT testing increased the accuracy, even for pre-malignant processes.

Option 2:

A Calprotectin/Transferrin/FOB/Hb-Hp combo test for the qualitative detection of Calprotectin, Transferrin, human haemoglobin and Haptoglobin-Haemoglobin in human faecal specimens. This test is CE certified and takes only 5 minutes to provide a test result.

Test Name	Specimen	Time to result	Sensitivity	Specificity	Accuracy
Calprotectin / Transferrin / FOB / Hb-Hp Combo Test	Faeces	5 mins	Calprotectin = 96% Transferrin = 99.1% FOB = 98.3% Hb-Hp = 97.9%	Calprotectin = 99% Transferrin = 98.5% FOB = 99.4% Hb-Hp = 98.6%	Calprotectin = 98% Transferrin = 98.8% FOB = 99% Hb-Hp = 98.4%

Cervical Cancer Screening

The popular method of cervical cancer screening is based on cytological analysis of endocervical swabs. However there is a precursor lesion of cervical cancer which leads to over 95% of cancers in this area. Human Papillomavirus (HPV) infection can be detected in vaginal swabs and will select out those individuals that require cytological assessment, more rigorous surveillance or colposcopy.

There are a number of HPV variants that exist and not all carry the same risk of cancer development. Low risk HPV variants are often associated with the presence of genital warts but do not lead to a significantly increased risk of cancer. High risk HPV variants are associated with over 90% of cervical cancers with the two highest risk HPV variants 16 and 18 causing 58% and 16% of cancers respectively. The other high risk HPV infections are HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Australia has now introduced self-screening vaginal swabs to detect HPV infection and identify the group of women that require further surveillance / treatment. Alongside this approach is vaccination against HPV to children of school age. The UK and the Netherlands have also introduced screening for HPV by self-testing as pilot projects. The UK’s pilot project took place in a select few north London boroughs where either women aged 25-64 years who were 15 months overdue for a check, or women who attended a GP appointment for another reason and were at least six months overdue a test, were offered a home test kit. The at-home test kit is an alternative to carrying out the swab via a healthcare professional (eliminating the degree of training required and invasiveness of the test compared to endocervical smear cytology), thus allowing more women to stay up to date with their routine cervical screening, and also reducing the total cost involved.

We can offer a combination of the swab sampling device, storage tubes and the PCR mix solution (this detects all 14 high risk HPV infections) while separately identifying HPV 16 and 18 in the same mix and experimental design. Once carried out, the swabs are stable for five days at 4^oC and for twelve months at -20^oC (normal freezer temperature).

The swab devices are CE marked and come complete with the tube containing preservation fluid. The PCR mix solution is also CE marked and is compatible with most thermal cyclers on the market. Therefore purchasing swabs and the PCR mix should give a turn key solution to HPV detection.

Once the swab is sent to the laboratory it is processed via Polymerase Chain Reaction (PCR) technology to detect the presence of HPV. The process of PCR is well established in most laboratories as it was used widely to detect the presence of SARS-CoV-2 infection during the pandemic. The infrastructure is already in place to carry out widespread screening of eligible women in most countries. In the event that this is not widely available, Kudu Spectrum can also provide PCR analysers.

Prostate Cancer Screening

Initiative is to screen eligible males with a simple to perform point of care test which gives results within ten minutes. This will serve the purpose of selecting those individuals for further investigation whether it be MRI prostate / prostatic biopsy, urology referral and/or confirmation of raised PSA using a quantitative method (e.g. laboratory assay). The current level of PSA used for further investigations is 4ng/ml. which is the level of detection used by the proposed semi-quantitative assay.

The strategy would be to semi-quantitatively test the number of 45-64 year old males in the population, selecting out those with a normal PSA and then quantitatively testing the remaining males with a positive lateral flow result using an immunofluorescence analyser. The population screen should be repeated yearly for all eligible males.

Test Name	Kit Size	Specimen	Time to result	Sensitivity	Specificity	Accuracy
Prostate Specific Antigen (PSA) Rapid Test Cassette	25	Whole Blood / Serum / Plasma	10 mins	100%	96.4%	98.0%

Liver Cancer Screening

Current liver screening programmes combine ultrasound and AFP measurement. Ultrasound is notoriously inaccurate in detecting small liver lesions in the fatty liver population.

Similar to the PSA screening an initiative could be set up to screen eligible citizens with a simple to perform point of care test which gives results within ten minutes. This will serve the purpose of selecting those individuals for further quantitative investigation.

The strategy would be to semi-quantitatively screen anyone with Cirrhosis or anyone who is either Hepatitis B or Hepatitis C positive. Those with an abnormal AFP level will be quantitatively tested using an immunofluorescence analyser. The same analyser can be used for both PSA and AFP screening. Eligible individuals should be invited back for repeat ultrasound and AFP test every six months.

Test Name	Kit Size	Specimen	Time to result	Sensitivity	Specificity	Accuracy
Alpha-Fetoprotein Rapid Test	25	Whole Blood / Serum / Plasma	10 mins	99.1%	98.9%	98.9%

Alternatively to AFP detection, Kudu can offer a multi analyte blood test combined with machine-learning technology in a groundbreaking algorithm for the detection of hepatocellular carcinoma – the most common form of liver cancer. The test is 20% more sensitive than ultrasound alone, and has a higher sensitivity and specificity than the combination of ultrasound + AFP. The test combines cfDNA methylation markers with patient demographic information and clinically available HCC tumor markers (components of the GALAD score) to enable robust and accurate HCC detection.

Breast Cancer Screening

Breast cancer is the leading cause of cancer deaths in women today. According to the World Health Organisation (WHO), one in every 12 women have the risk of a breast abnormality. Early diagnosis is very critical to decrease mortality rates.

We offer a novel artificial intelligence-based medical device to detect breast cancer at a much earlier stage than traditional methods or self-examination. The high resolution thermal sensing device solution is a low cost, accurate, automated, portable cancer screening tool that can be operated in any clinic. The imaging method is radiation free, non-touch, not painful, and works for women of all ages. The core technology of the solution has been developed using a patented machine learning algorithm for reliable and accurate detection of breast cancer. This unique solution can be used as a cancer diagnosis test in hospitals, for regular preventive health checkups, and also for large scale screening in rural and semi-urban areas.

The thermal device is placed 3 feet in front of the patient and captures 5 thermal images of the region. The accompanying software automatically analyses these images and sends the analysis report to be certified by a Senior Radiologist. There is no minimum age for thermographic screening, it does not depend on the age, colour, race or density of breast.

Test Name	Specimen	Sensitivity
Breast Cancer Screening [CE certified]	Thermal Breast Images	Results from clinical trials indicate very high accuracy that is non-inferior to X-Ray Mammography in general, and 25% better sensitivity than mammography in women with dense breasts.