TruScreen Obtains Chinese CFDA Approval

Published: 30 April 2015

Obtaining Chinese CFDA Approval Opens a Huge Market to TruScreen Limited

TruScreen has now open access to a potential NZD $1 billion per annum market after receiving Chinese Food and Drug Administration (CFDA) approval to market their device in China. This approval and accreditation represents a watershed moment in the evolution of the Company.

TruScreen’s cervical cancer technology utilises a digital wand which is touched on the surface of the cervix to measure electrical and optical signals from the surrounding tissue to identify precancerous change, or cervical intraepithelial neoplasia (CIN).

The Company’s revolutionary technology, which took scientists over 15 years to develop, will now be immediately available to Chinese women following a series of successful trial and marketing programmes.

TruScreen’s CEO Martin Dillon said “the Chinese market represents a very significant commercial opportunity for the Company.”

“With 388 million women aged 25-60, China is probably the world’s largest market for cervical screening worth an estimated NZD $1 billion per annum. There is currently no national programme in place in China, and with an increasing focus on women’s health we are well positioned to strengthen our existing presence there.” says Dillon.

“Large scale trial programmes conducted by the company in several key hospitals in China was a key factor in securing the China Food and Drug Administration (CFDA) approval.”

“Our Clinical and Familiarisation trials using the TruScreen device involved testing thousands of women in China. The positive feedback about the device’s efficacy helped us secure not only the CFDA approval but also contracts with some of the country’s largest medical distributors,” says Dillon.

“We have signed contracts with three key distributors in China who between them cover all customer segments. Our distributors have a combined national sales force of more than 3,000 medical professionals – which provides some idea of the scale and potential of the market.”