EH 6/2014

You’re not the only one who needs to trust the test results ACCURACY THE FIRST TIME For In Vitro Diagnostic Use. Not available in all countries. © 2014 AB SCIEX.The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners.AB SCIEX™ is being used under license. IVD-MKT-13-1360-A Clinicians and patients count on the most reliable diagnostic answers. We want you to be confident that results are as timely and accurate as possible. SCIEX Diagnostics offers an in vitro diagnostics solution with exceptional assay performance that helps overcome the limitations of current testing methods. Our newly introduced assays for Vitamin D, Newborn Screening and Immunosuppressants accurately measure multiple analytes in a single run, and virtually eliminate the need for re-runs and send-outs. And not only are SCIEX Diagnostics solutions backed by over 25 years of leadership in mass spectrometry, they are surprisingly affordable, too. Find out how SCIEX Diagnostics can help improve your accuracy, turnaround and confidence at www.sciexdiagnostics.com MASS SPECTROMETRY SOLUTIONS FOR IN VITRO DIAGNOSTICS Diagnostics www.european-hospital.com 13LABORATORY Jie Ren received a master’s degree in Cell and Molecular Biology from Fordham University in New York and a Masters in Veterinary Infectious Diseases in China. At Whitney Research she focuses on the molecular testing market. bag full of cash for R&D80% in east China, 70% in middle China, and 60% in West China, all by 2015. Blood screening test reagents are registered in the CFDA drug depart- ment, with very strict requirements. Thus the blood screening nucleic acid test market has few players, including Roche, Novartis (Chiron), Shanghai Haoyuan, Kehua, and Daan. Gene sequencing, with major clinical use in prenatal testing, In 3-5 years, the net manufacturers’ revenue from prenatal tests will be around $600-700 million annually. Gene sequencing for cancer and genetic disorders is also accelerat- ing. Companion diagnostic tests have already seen rapid growth, according to our interviews with lab leaders in Class III hospitals. Molecular diagnostics requires skilled professionals and expensive instruments, which limits their market in lower level hospitals. Cost effective, easy to operate point of care (POC) products will expand the lower level market for molecular diagnostics, as well as show up in satellite and spe- cialist labs. More molecular automation and integrated instruments are the future trends for large labs but the number of healthcare institutions outside large city hospitals increases exponentially. Again, many foreign companies are collaborating with Chinese firms to take full advantage of the market. Enigma Diagnostics, with a very impressive molecular POC offering, has teamed with the reagent firm Leadsman to enter the market from which Cepheid has out-priced itself. UStar, which we identified as a top prospect to the Gates Foundation and FIND (Foundation for New Innovative Diagnostics) in Geneva, has an inter- esting technology for molecular POCT and is now directly invested in by Gates and Lenovo to broaden the UStar product portfolio. Many interesting developments in molecular POCT are progressing, pri- marily with overseas Chinese finan- cially supported to bring innovation to Chinese firms. These innovative molecular diagnostic companies are the new darlings of the Chinese fund- ing programmes as well as independ- ent foreign investors. Overall, the molecular diagnostic market is very lucrative in China. Nonetheless, some obstacles still exist – registration possibly among the first. All class II and class III products not on the exemption list must do clinical trials in China. The China Food and Drug Administration (CFDA) rules require imported products to be reg- istered in their home countries before applying for CFDA approval. Therefore, joint venture and col- laboration with domestic companies has been a way to expedite Chinese market entry. Both Illumine and Life Technologies recently chose to expand their China gene sequencing market through local partnerships. After 20 years of PCR, gene sequencing faces a similar situation in China. Beginning in 2011 with prenatal testing, early this year the CFDA and National Health and Family Planning Commission (now including the former Ministry of Health) banned clinical use of gene sequencing, but requested applications for an experi- mental centre and began to take appli- cations to register products one month later. To date, no experimental centre has been approved and only BGI received CFDA approval, in a quite speedy fashion, for gene sequencing for clinical diagnostic purposes. Daan received their sequencing approval in November 2014. Several other gene sequencing companies have applied. Foreign gene sequencing products must first be approved in their home country and only Illumina, which approached China by collaborating with local firms, has received home country approval. The Health and Family Planning Commission is encouraging class III hospitals to purchase domestic medical instruments, empowering the country’s Association of Medical Instruments to select high quality, competitive domestic medical instru- ments and reagents – finally creating a catalogue and evaluation system as a purchasing reference. This started with X-ray and ultra- sound machines and biochemistry analysers. Selection standards include 60% technical performance, 20% pro- fessional opinions and 20% company performance, plus company size, sales volumes, market share, financial con- dition and service. This policy may also increase merger and joint ven- tures between foreign companies and domestic companies. We think we see a shift in the government monetary awards to manufacturers, in keeping with other reforms that President Xi has pri- oritised. If followed, grants will no longer go to mediocre establishments with ‘relationships’, but will be based on real innovation and technologi- cal merit. Collaborating with foreign companies will be encouraged – so, as a prospective grantee or grantee partner, you’d better watch out. Just being mediocre will not make it. Just be ‘good’, for goodness sake.

EH 6/2014

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