China Medical Technologies get Chinese SFDA approval for HPV analyser
China-based in-vitro diagnostic (IVD) company China Medical Technologies
Inc (Nasdaq:CMED) told investors that it has received approval from the
State Food and Drug Administration of China (SFDA), for a microchip
which is designed to analyse and indentify the human papillomavirus
(HPV) - a primary cause of cervical cancer.
According to China
Medical Technologies, its SPR (Surface Plasmon Resonance) based HPV-DNA
Chip can detect genotypes which are at high risk from HPV, by placing a
patient's sample on one chip and processing the chip through its
fully-automated SPR analyzer.
The technology can also identify
low-risk genotypes, distinguish multiple HPV infections, and determine
the viral load. The analysed data can prove important for physicians in
order for them to recommend patient treatment.
HPV is a common
virus, which infects the skin and mucous membranes and causes various
kinds of warts as well as cervical cancer. The company note that over
100 HPV subtypes have been identified, including 16 high-risk HPV
subtypes which can lead to the development of cervical cancer and 8
low-risk HPV subtypes which can lead to genital warts.
In terms
of the HPV-DNA Chip’s potential market, the company highlighted a report
by the World Health Organisation (WHO). According to the WHO, China has
a population of about 500 million women aged 15 years and older who are
under the risk of cervical cancer. Furthermore, China Medical
Technologies cited a statistic from the Chinese Ministry of Health which
states that approximately 70 million gynecological check-ups were
conducted in China during 2008.
China Medical Technologies
develops, manufactures and distributes its products which are used for
the detection of various cancers, diseases and disorders. China Medical
Technologies generates all its revenues in China through the sale of
diagnostic consumables including FISH probes, SPR-based DNA chips and
ECLIA re-agent kits to hospitals.
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