Research & Development
Group B Streptococcus
Hologic acquires Diagenode for $159 million
Diagenode offers clients more than 30 polymerase chain reaction (PCR) tests, as well as a portfolio of devices, kits, reagents, and antibodies for DNA and RNA analysis.
February 28, 2021
Pathologists advance understanding of deadly female genital tract infections
Group A strep is typically found in the mouth, but it can also infect other mucosal areas of the body, with deadly results. The researchers noted that GAS surface proteins cause an estimated 700 million human infections annually around the world, including 15 million in the U.S. GAS is at the root of puerperal sepsis (also known as childbed fever), which is the leading cause of maternal deaths, and it causes necrotizing myometritis (inflammation of the uterine myometrium) as well as severe infections in newborns.
March 18, 2020
Luminex MRSA test clears FDA
The Aries MRSA assay tests directly for MRSA DNA from nasal swabs in patients at risk for nasal colonization. Clearance was granted on September 25 and announced by the company on October 1.
September 30, 2019
What the rise of urgent care centers means for labs
The number of urgent care centers in the U.S. is expected to increase from approximately 10,600 currently to more than 12,000 by 2023, according to the report, titled "The Market for Urgent Care Centers" and published August 6. This will produce $3 billion in marginal dollars earned by urgent care centers across the nation in the next five years. For laboratorians and IVD vendors, it is an important area to watch, as urgent care centers increasingly offer point-of-care testing on-premises. Some larger urgent care centers even feature more complex laboratories.
August 15, 2019
NeuMoDx launches 4 new CE-IVD tests
The assays work with the company's NeuMoDx 96 and NeuMoDx 288 molecular systems.
June 25, 2019
Meridian acquires GenePOC from Debiopharm
Through the deal, Meridian will gain GenePOC's revogene product for microbial testing, which incorporates polymerase chain reaction (PCR) techniques for rapid testing in cases where infectious diseases are suspected. The product is marketed in the U.S., Europe, and Canada.
April 30, 2019
Kalorama's notable product launches for clinical labs in Q1 2019
In the POC segment, one of the breakthrough approvals from the U.S. Food and Drug Administration (FDA) was for the Sangia total prostate-specific antigen (PSA) test by Opko Health (Woburn, MA) in January. The Sangia test is the first POC test that quantitatively measures total PSA in capillary whole blood, and it is approved for use with the digital rectal exam (DRE) to screen for prostate cancer in men 50 years and older. The test can be administered with a finger prick and results are generated in 12 minutes.
April 24, 2019
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