Spring has come for the genetic sequencing industry. Manufacturers and service providers previously devastated by the CFDA announcement on the prohibition of clinical testing for genetic sequencing in February 2014 can now take courage in the recent approval of a second generation sequencers from BGI (Shenzhen, China).
After acquiring the technology from Compete Genomics (California, USA) for earlier 2014, BGI has worked hard with CFDA to introduce this device to the Chinese market. To this effect, CFDA has published their classification in January 2014 (announcement), specifying that genetic sequencing analysers for human DNB and RNA sequencing are Class III medical devices in China (highest risk category). However, with the prohibition on all genetic screening announced in February, this project has gone silent until now.
Last week, BGI has proudly announced the registration of the first approval by CFDA for second generation sequencing products. The registration certificates obtained on 30 June 2014 are for the:
- BSISEQ-100 and BSISEQ-1000 sequencers
- Detection kit for noninvasive fetal trisomy (T21, T18, T13) test [combinatorial probe-anchor ligation sequencing method]
- Detection kit for noninvasive fetal trisomy (T21, T18, T13) test [semiconductor sequencing method]
With the world’s largest population, these prenatal screening products should find ample appetite for it in the Chinese market.
In the meantime, manufacturers and service providers read the news as the first indication of the tide change on genetic sequencing products.
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