FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...

Advances in Gene Sequencing Technology Enable Scientists to Respond to the Novel Coronavirus Outbreak in Record Time with Medical Lab Tests, Therapies

Scientist described the speed at which SARS-CoV-2’s full sequence of genetic material was made public as ‘unprecedented’ and medical labs are rushing to validate tests for this new disease In the United States, headlines scream about the lack of testing for the novel Coronavirus disease 2019 (COVID-19). News reporters ask daily why it is taking so long for the US healthcare system to begin testing large numbers of patients for SARS-CoV-2, the virus that causes COVID-19. Yet, pathologists and...

Johnson & Johnson Says It Is ‘Exploring All Options’ for Selling, or Spinning Off, Its Ortho Clinical Diagnostics Unit That Sells Clinical Laboratory Products

Any change of ownership in the fifth largest in vitro diagnostics company would represent a major development in the medical laboratory testing marketplace Medical laboratory managers may see more consolidation in the in vitro diagnostics market if executives at Johnson & Johnson (NYSE: JNJ) decide to sell its Ortho Clinical Diagnostics (OCD) unit. This decision was announced earlier this week during J&J’s conference call to discuss its fourth quarter 2012 financial report. Ortho...

Digene Sells to Quiagen, Has Sued Third Wave and Ventana to Protect HPV Patents

Earlier this week, Digene Corporation (Nasdaq: DIGE) announced that it would be acquired by Dutch firm Qiagen (Nasdaq: QEN) for a purchase price of approximately $1.6 billion. Digene has been involved in patent infringement lawsuits during the past year in efforts to protect its HPV patents. It was announced on Monday, June 4, that Digene will be purchased by Qiagen, a Dutch maker of tools for gene research. This gives Quiagen access to Digene’s patented HPV test, and tests for sexually...

Cytyc to be Acquired by Hologic

In a deal made public only Sunday, Cytyc Corporation has agreed to be acquired by Hologic. Hologic will pay $6.2 billion for Cytyc, which had revenues in 2006 of $608 million. The price paid represents a 33% premium for Cytyc shares, based on prices at the close of the market on Friday. When the deal closes, probably sometime between July 1 and September 20, another in vitro diagnostics (IVD) manufacturer will have lost its independence. In this acquisition, Hologic’s prime interest is not...
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