BY SAARANI VENGADESEN & THIVIYA DARMARAJAN
BIOGENES TECHNOLOGIES (BIOGENES) is already known for its novel innovation of diagnostic kits using an aptamer-based biosensing platform to replace the use of animal-derived antibodies.
After successfully innovating aptamer-based diagnostic kits to detect the Covid-19 virus and sepsis infection – the company is developing a similar diagnostic kit to detect the Human Papillomavirus (HPV), which causes cervical cancer.
The kit is all set to enter the clinical trial stage this year.
Cervical cancer is the fourth most common cancer in females worldwide, but it is a curable cancer if detected in the early stage.
“The Malaysian government has introduced HPV vaccination and created awareness on cervical screening among the public, but there are still gaps for early detection of cervical cancer,” said Dr Shazana Hilda Shamsuddin, biosensor researcher from the Department of Pathology, Hospital Universiti Sains Malaysia.
Shazana citing the Malaysia Cancer Registry Report (2012-2016), said 76% of cases are diagnosed at later stages, which are stages two, three, and four.
“Most women are reluctant to go for pap smear as it is an invasive technique. Only 22% of Malaysian women submit themselves for pap smear, and it has a potential error during sampling and less sensitive in detecting early cervical cancer because it relies on cytological smears.”
“Another alternative we have is HPV DNA testing but it is costly and only available in certain laboratories in Malaysia.”
As a specialist in the area of biosensor and bio-nanotechnology, she could immediately see aptamers as the perfect fit to overcome the limitations in current testing methods such as pap smears and DNA testing.
According to her, aptamers are synthetic analogue to antibodies that replace monoclonal antibodies. In her HPV biosensor research, the HPV aptamers are designed in collaboration with the biocomputational team from Biogenes using Aptamer Computer Aided Device (APTCAD) platform.
She said aptamers are folded into a specific shape and they target specifically the protein of interest. For HPV detection, the aptamer detects oncoproteins instead of capsid proteins, which can differentiate latent infections from persistent infections with carcinogenic effects of the virus on the tissue.
Currently, the HPV DNA testing is detecting the virus capsid gene, which unable to differentiate between these infections. Hence, it may lead to false positivity and unintentional anxiety to the patient.
More precise detection is required because not all HPV viruses lead to cervical cancer. The body will naturally fight HPV infection for 9 to 12 months. However, the virus will induce cervical carcinogenesis approximately within 15 to 20 years if the body fails to fight the virus.
The aptamer-based diagnostic technology will be able to detect carcinogenic infections to be treated, she said. She also said that using an aptasensor, HPV can be detected with urine tests and can be carried out by the individual themselves within the comfort and privacy of their homes.
She said: “It eliminates the invasive method which makes women reluctant to go for screening. In the future, we are looking into making this test kit which is affordable and readily available as the Covid-19 test kit. Currently, the existing diagnostic modalities range from RM40 to RM4000. The aptasensor test kit can be cost-effective because it is completely homegrown and has no minimal import cost included.”
“With this new test kit, I am confident it would also reduce the national healthcare burden and the waiting time for the test results. Antibody-based detection will take around two days for the results to be known, but with aptasensor test kits, results can be obtained in less than one hour.”
She said the aptamer-based histochemical staining could be an alternative to cytological staining test methods – especially in pathology labs that do not have molecular testing facilities.
“Aptasensor is the future technology for diagnostic test kits. These new generation test kits can help attain the World Health Organisation (WHO) target of zero-cervical cancer by 2030,” she added.