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TruScreen Receives CFDA Approval for its Second Generation

Regulatory4 December 2017TRUIndustrials

NZX and Media Release 4 December, 2017
NZX Limited

WELLINGTON


TruScreen Receives CFDA Approval for its Second Generation Device in China


Cervical cancer screening technology company, TruScreen Limited (NZAX: TRU) is pleased to advise

that the China Food and Drug Administration (CFDA) have issued its formal certificate of approval

permitting the commercial supply and sale in China of the new upgraded TruScreen2 cervical cancer

screening device.

TruScreen CEO Mr Martin Dillon said “CFDA registration is, by global standards, an extremely

rigorous validation process which certifies the engineering, quality and efficacy of our product for

use in our major market , China. The company has been steadily building up its inventories in

anticipation of receiving the registration and will now commence export sales of the new device to

China as soon as practicably possible.”


ENDS

For more information visit www.truscreen.com or contact:

Martin Dillon

TruScreen Chief Executive Officer

Email: martindillon@truscreen.com

Media Liaison

Jackie Ellis

Email: jackie@ellisandco.co.nz

Phone: +64 27 246 2505


About TruScreen:

TruScreen’s real time cervical cancer technology

utilises a digital wand which is placed on the

surface of the cervix to measure electrical and

optical signals from the surrounding tissue. A

sophisticated proprietary algorithm framework

distinguishes between normal and abnormal

(cancerous and precancerous) tissue to identify

precancerous change, or cervical intraepithelial

neoplasia (CIN). A Single Use Sensor (SUS) is used

for each patient to protect against cross-infection.

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