Feb 20, 2019
Seegene has announced that they have completed development of 16 new products including 14 of CE-IVD marked new products are now release in the European market.
After receiving CE-IVD certification for a total of 8 products in June 2018, including detection product for meningitis and antimicrobial resistance, In December 2018, Seegene has launched 8 additional CE-IVD marked products, and 2 RUO (research-only) customized products specialized for India and the United States. And following that, 6 new products were now certified in February 2019. This means that a total of 16 products are newly developed and released by Seegene within just 8 months.
While it usually takes 2 to 3 years from the planning stage to the launch of a single product, it is nearly impossible to complete acquisition of certificates for multiple products within 6 to 8 months without extensive investment. However, Seegene was not only able to significantly shortened the oligo design process using the in-silico system made based on its know-hows as the foundation, but also reduced the labor and cost as well as the development period through validation using the SGDDS.
Among the products to be launched, 14 of them ? 3 STI detection products, 7 respiratory infection test products, and 1 test product for Helicobacter pylori and clarithromycin resistance? have been approved as clinical trial products in Europe.
In particular, a number of symptom based screening products have been released that can report within one day, including AllplexTM Bacterial Vaginosis Plus Assay, which is the first in the industry to be able to conduct a full simultaneous quantitative test for female vaginitis, AllplexTM Vaginitis Screening Assay, which is suitable for mass screening tests and AllplexTM MG-AziR Assay, a product that can simultaneously detects MG and drug resistance to MG that causes urethritis and cervical inflammation. In addition, Seegene also released a product for a test for the most prevalent causative 7 pathogens of acute diarrhea - AllplexTM GI-EB Screening Assay, a simultaneous test product for 9 parasites that causes diarrhea - AllplexTM GI-Helmints(I) Assay, and a respiratory infection related product for mass screening tests - AllplexTM RV Essential Assay.
These all newly launched products will be presented under the title “First Line Syndromic Solution” at ECCMID, the largest clinical microorganism society in Europe, which will be held in Amsterdam for 4 days starting April 13, 2019.