Author: mallyse

In July, the China Food and Drug Administration (CFDA) approved the registration of four gene sequencing products, opening the gene sequencing market, frozen over the previous six months, and reversing its previous conservative and cautious attitude, Shanghai-based China Business News reports.

In 2013, China’s non-invasive prenatal testing market had a scale of about 1 billion yuan (US$161.9 million), with BGI and Berry Genomics taking a dominant market share. Non-invasive prenatal testing is increasingly being adopted by high-risk pregnant women for the screening of common fetal chromosomal aneuploidies. Read more.

The Food and Drug Administration announced on Thursday that it would start regulating medical laboratory testing, saying that tests used to make important treatment decisions must be vetted and validated before they go into use.

The decision, long in coming, has been fiercely opposed by some laboratories and pathologists, who have said that regulation by the agency is unnecessary and would significantly increase the cost and time needed to develop tests, stifling innovation and depriving patients of some vital tools. Read more.