6 COVID-19 test kits obtained CE mark

Cepheid announced on Thursday that it has obtained the CE mark for a rapid molecular test to detect the SARS-CoV-2 virus. The new test will begin shipping this month.

LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.

On May 18, the treatment report of the first Chinese produced SARS-CoV-2 oral drug was announced.

The Food and Drug Administration published a Class I recall report for two COVID-19 testing products that covers the removal of more than 51,000 unauthorized coronaviurs tests from the U.S. market.

Genomics and diagnostics company Prenetics ended its first day as publicly traded company on the Nasdaq on Wednesday with its stock down 9 percent.

On May 18, Yunkang Group was listed on Hong Kong Exchanges and Clearing Limited (HKEX), stock code: 2325.HK. At press time, it opened down over 10% with a total market capitalisation of approximately HK$4.3 billion.

On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.

Achiko announced Tuesday that it has obtained the CE mark for its COVID-19 AptameX test and system, enabling its use in the European Union and other regions that accept the designation.

On May 14, Fosun Pharma announced that its holding subsidiary Fosun Pharma Industry signed a contract with Kite Pharma. Proportional capital increase, and subscription of the new registered capital equivalent to Fosun Kite.

Qiagen said on Monday that a higher-capacity version of its QiaStat-Dx automated syndromic testing system has received CE marking.

The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.

The US Food and Drug Administration earlier this month granted Emergency Use Authorization for Abbott's ID Now COVID-19 2.0 rapid point-of-care test.

On May 10, the National Development and Reform Commission issued the "14th Five-Year Plan for Bio-economic Development" (hereinafter referred to as the "Plan"), which is also the first top-level design in China's bio-economic field.

Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.

BioMérieux announced on Friday that it has obtained the CE mark for two immunoassays to detect Chikungunya virus infection.

Mindray plans to distribute a cash dividend of 4.23 billion CNY. Hybribio plans to invest 1.512 billion CNY to build Medical Science Park. USCI completed hundreds of millions of CNY of financing and accelerated to lead the early screening track of liquid biopsy and women's health.

Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.

Becton Dickinson has received 510(k) clearance from the US Food and Drug Administration for the MX molecular diagnostics module along with a triplex assay for chlamydia, gonorrhea, and trichomonas.

Spatial proteomics firm Ionpath said on Wednesday that it has received a strategic investment of undisclosed size from Thermo Fisher Scientific.