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

0

���� trouble of hospital visits , and provides a safe and women-friendly alternative .

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

����

���������� 250 cases

���������� ���������

���������� ���������

���������� ���������

���������� ���������

���

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