Novacyt (Paris), a specialist in cancer and infectious disease diagnostics, has received approval for its new consumable NOVAPrep HQ+ orange from the China Food and Drug Administration (CFDA).
The CFDA has approved the NOVAPrep HQ+ orange consumable which includes a new medium that better preserves the cervical samples for cytology and also for HPV testing. This follows the CFDA approval of the NOVAPrep platform in 2014 and completes the necessary regulatory approvals for Novacyt to expand into the highly significant Chinese oncology diagnostics market.
The NOVAPrep HQ+ orange sample preservation consumable has a number of advantages over traditional liquid based cytology consumables. Its unique design improves the sensitivity and specificity of collected samples, while the new medium provides excellent stability ensuring samples are neither damaged nor degraded prior to testing which is a significant advantage for HPV reflex testing.
Graham Mullis, Group CEO of Novacyt, said: "With NOVAPrep HQ+ orange now approved in China, we are ready to commercialise NOVAPrep into this rapidly expanding cytology market which is forecast to be the largest cytology market in the world during the next five years. I look forward to updating everyone with our plans for this important market in due course."
The approval of the platform and the consumable follows a series of new developments for Novacyt since its merger with Lab21 in 2014. Since then, it has delivered strong double digit sales growth in 2014, raised €3.1 million, expanded in new markets, including the Far East and Middle East, and secured new patents for NOVAPrep to maintain its strong proprietary and competitive position in the cytology market.
The Novacyt Group makes cellular diagnostics with a growing portfolio of cancer and infectious disease products and services. Through its technology platform NOVAPrep and a strong international network, Novacyt is able to provide an extensive range of oncology and infectious disease diagnostic products.
Meridian gets CE mark for Chlamydia tests
Meridian Bioscience (Cincinnati) has received the CE mark for two new molecular diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), the sixth and seventh assays on the illumigene platform.
Along with these two new assays, Meridian also received the CE mark for a sample preparation system, M-prep, that is designed to facilitate the isolation of Chlamydia and Gonorrhoeae from clinical samples. All three products will be distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the company's global distribution network.
The illumigene CT & NG assays utilize endocervical swabs, self-collected vaginal swabs, and female and male urine, making collection easy and non-invasive for physicians and patients. The test procedure is universal for all specimen types, and takes less than one hour to report a final result. Unlike other molecular systems, the illumigene platform requires no expensive capital equipment, and no costly annual service contracts. The performance and simplicity of this technology, along with its cost efficiency and small footprint, makes these new assays ideal for enabling a more rapid diagnosis, the company said.
The company also reported CE mark for its new test for Streptococcus pneumoniae. TRU STREP PNEUMO is a rapid, qualitative immunoassay for the detection of S. pneumo antigen in urine and CSF and will be distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company's global distribution network.
Meridian makes a range of diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.
Kenya picks GE Health as strategic partner
As part of a what it calls a wide-scale healthcare transformation program, one of the largest of its kind in Africa, the Kenyan Ministry of Health (MoH) has named GE Healthcare (Chalfont, St. Giles) as a key strategic technology and solutions partner, following the conclusion of an open tender process.
Through the program, GE Healthcare will bring a comprehensive package, including its advanced technologies and capabilities in design and software, covering:
1. The deployment of over 585 units of diagnostic imaging equipment including X-ray and ultrasound systems supported by a long-term servicing contract;
2. Training and education programs in line with GE Healthcare's focus on skills development and capacity building;
3. Scope for the assessment and potential establishment of a GE Healthcare Training Center to be run jointly with an accredited local partner. If established, it would become the first training center for GE Healthcare in Africa.
Over the coming months the GE Healthcare team will be working in close collaboration with the MoH, local project management partners and Project Partners, including the relevant county healthcare administrators and recipient hospitals, to ensure the rapid and successful implementation of the program. Further details on the deployment schedule in the respective counties will be made available in due course.