OCTOBER 1- OCTOBER 14, 2016

By Susanna Lim

susannamenonlim @ malaysiasme. com. my

Pics by YC Chu

chuyc @ malaysiasme. com. my

small Malaysian firm has created an affordable and accessible medical device which will encourage early detection and treatment of cervical cancer in women. The company is currently on the lookout for funding for operation, market development, and branding purposes.

The medical device, Cervisafe, allows women to collect their own cervical cell samples for screening instead of visiting a hospital for the traditional pap smear – widely accepted as the gold standard for detecting the cancer.

The two-year old company, LaDIY Healthycare, says it plans to launch Cervisafe in Malaysia by October 2016 and will soon make it available at GP clinics and pharmacy chains nationwide by January 2017.

The company has set out to provide an accessible, affordable form of self-diagnosis of the human papillomavirus( HPV) in women, which causes cervical cancer.

According to Romli, director of LaDIY Healthcare, the problem with pap smears, which use conventional cytology methods, is that they only detect changes in cells once the cancer has started to progress.

“ If there are no changes in cells, nothing comes up on the pap smear. So a woman who goes in every year for a pap smear and whose tests are initially clear, could suddenly discover during the next annual test that the cancer has already progressed to stage 2,” he added.

Cervisafe, unlike the traditional pap smear, focuses not on detecting cell formation but instead on detecting HPV DNA in women using liquid-based cytology.

“ The cause of the cancer is the HPV virus, so by detecting the presence of HPV on the cervix, a woman can then consult a doctor on how to eliminate the virus before it attacks the cells.”

The samples are then sent off to laboratories which have partnered with LaDIY Healthcare. If necessary, Romli added that the company updates these laboratories with the facilities required for the company’ s HPV DNA screening system and liquid-based cytology method.

Liquid-based cytology samples have been shown to offer better clarity, uniform spread of smears, less time for screening and better handling of haemorrhagic and inflammatory samples as compared with conventional cytology used in pap smears, according to a study by the Postgraduate Institute of Medical Education and Research in India.

Besides its claimed accuracy, the product is reasonably priced at RM300 per screening set. This includes a sampling kit, the logistics of delivering the sample to a lab, as well as cytology results. It also saves women the

Unlike the traditional pap smear, Cervisafe focuses not on detecting cell formation but instead on detecting HPV DNA in women using liquid-based cytology.

Annual number of new cases of cervical cancer

Annual number of cases and ����������c incidence rates of cervical cancer in Malaysia( estimations for 2012)

1500

1250

1000

750

500

250

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Romli added that there is an alarming rate of cervical cancer deaths in Malaysia, with a woman dying every 14 hours from the disease. In fact, statistics show that cervical cancer is the fourth leading cause of death for female cancer in Malaysia.

“ The number of cases in Malaysia is increasing every year. What’ s ironic is that cervical cancer is the only cancer you can prevent.”

Given the MedTech industry boom sweeping ASEAN, the potentially disruptive home-grown startup is on the lookout for both local and regional partners.

The company’ s goal for the coming year is to get Conformité Européene( CE) and US-FDA registered, and it is on track for both certifications, according to Romli.

Presently, the start-up is on the lookout for RM2 million in funds for operation, market development and branding purposes, Romli told MALAYSIA SME ® in an exclusive interview at the Medical Fair Asia 2016 in Singapore recently.

The company has appointed two distributors in South Africa and India, and will soon partner with distributors in Indonesia, Nigeria and Oman.

R & D work for Cervisafe began in 2011 and clinical validation was completed in 2014. A major portion of the initial capital came from BiotechCorp, with a total sum of

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Source: Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [ Internet ]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http:// globocan. iarc. fr.

RM1 million. LaDIY also received a Commercialisation of Research & Development Fund( CRDF) grant from the Malaysian Technology Development Corporation( MTDC), and the Market Development Grant( MDG) under MATRADE.

“ The process of application for both grants was very simple and easy. There wasn’ t much red-tape but it’ s most important that you comply with their requirements,” said Romli.

“ The original concept of Cervisafe was already in the market but the design of Cervisafe is unique and our own. We’ ve already applied for our own IP at Intellectual Property Corporation of Malaysia( MyIPO) and Patent Corporation Treaty( PCT) for worldwide filing. As for now, we’ ve got strong support from MTDC through their CRDF grant for our machines, marketing and promotion.” MSME