A Medical Device Daily

China Medical Technologies (Beijing) a manufacturer of in vitro diagnostic products, reported receiving Chinese State Food and Drug Administration (SFDA) approval for its Prenatal FISH Probe and Cervical Cancer FISH Probe.

The Prenatal FISH (fluorescent in situ hybridization) probe is a detection kit for the analysis of trisomies 13, 18 and 21 and sex chromosome aneusomies (X and Y).

The company said prenatal screening of trisomy 21 (Down syndrome) is becoming more prevalent in China and that its Prenatal FISH Probe can provide a quicker and more efficient confirmative approach to the prenatal screening results.

The Cervical Cancer FISH Probe is designed to detect the amplification of the TERC gene in human cervical tissue, which has been demonstrated to be associated with the severity of cervical disorders. Detection of the TERC amplification as a biomarker can provide better assessments of cervical disorders for clinical diagnosis, according to China Medical.

The company also reported that its Chinese subsidiaries have received approval for high-tech enterprise status from Beijing government authorities. With this status, the subsidiaries are entitled to an income tax rate of 15% instead of the statutory income tax rate of 25%. The status is valid for three years and will be eligible for renewal after evaluation by relevant government authorities every three years.

"We are pleased to receive SFDA approval for two of our FISH probes and achieve the high-tech enterprise status under new stringent criteria," said Chairman/CEO Xiaodong Wu. "With the SFDA approval, our hospital customers in different provinces can apply for the inclusion of the two FISH probes in the reimbursement menu of respective provincial medical insurance programs, which we believe will result in increased usage of the probes in the future."

He added that the high-tech enterprise status "demonstrates the government's recognition of our achievements in developing and manufacturing advanced innovative products. Furthermore, the ... government announced yesterday that an estimated amount of RMB850 billion will be spent in the next three years on healthcare reform initiatives, with a significant portion in medical insurance programs. We believe the IVD industry in China will strongly benefit from these initiatives."

Merge eyes gains in China

Merge Healthcare (Milwaukee), a medical imaging solutions provider, said it has solidified the leadership team for its Chinese operations.

"Because of the opportunity in this market, Merge has moved quickly to solidify sales operations for ShanghaiCo, now doing business as Merge China," said CEO Justin Dearborn. "China has the potential to be our biggest market in a few years."

Merge cited Frost & Sullivan (F&S) statistics indicating that China holds one-fifth of the world's aging population. With a per-capita healthcare expenditure that increased by eight times from 1979 to 2004, China controls a large percentage of the world's healthcare spending, that company said.

It added that recent Chinese government initiatives have further sparked investment in healthcare resources, particularly to populations outside of the major metropolitan areas of China. F&S said this has resulted in a medical imaging growth rate that outpaces most of the world and that revenues from advanced modality sales alone are expected to reach $1.5 billion by 2010.

"With a unique ability to provide toolkits and technologies for local medical imaging companies, as well as finished applications focused on easy web access, Merge is well equipped to meet China's market needs," Dearborn said. "We are excited to be an active participant in this growth."

Merge China was reacquired after the dissolution of a transfer agreement to Inqgen Technology Co. earlier this month.

Zhong Wang, who leads Merge China, has built a team that includes Diana Dai as sales manager; Weiming Li as customer operations manager; Feng Chen leading engineering; XinLiang Li leading customer service and Wei Chen leading HR, finance & administration.

All have extensive experience in medical imaging in China, as well as with the specific Merge solutions and customers there. "This team is already showing success in continuing our existing business and expanding development efforts," according to Wang. "I've been very pleased with the smooth transition."

Philippines is new market for USANA

USANA Health Sciences (Salt Lake City) has begun operations in the Philippines, the 14th market where independent representatives sell the company's nutritional supplements.

"During these tough economic times, USANA is fortunate to be able to continue its international growth," said Dave Wentz, CEO of USANA. "We believe the Philippines will be another strong market for our company."

USANA manufactures nutritionals, personal care and weight management products that are sold in the U.S., Canada, Australia, New Zealand, Hong Kong, Japan, Taiwan, South Korea, Singapore, Malaysia, the Philippines, Mexico, the Netherlands and UK.

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