Cepheid wins 1st FDA nod for point-of-care coronavirus test |



One of the most powerful engines in the United States is public-private collaboration. The symbiosis of government authority and funding along with the entrepreneurial motivation of industry leads to extraordinary results.  We saw this same occurrence. World War II when production facilities transitioned in a very short time to war output. Factories in Detroit, MI shut down automobile assembly lines to begin producing tanks, and jeeps.

Clinical laboratories and medical device manufacturers are tapping into today's high-speed broadband to accelerate testing for COVID-19.  Every great challenge mobilizes great advances in technology, production, and human interaction

The FDA has granted the use of the Cepheid  POS (point of service) for a variety of diseases, Critical Infectious Diseases such as those listed here can be tested in hospital and clinic without waiting for the return of results.

Xpert Xpress SARS-CoV-2 (EUA), Covid-19
Xpert Xpress Strep A
Xpert Xpress Flu/RSV
Xpert Xpress Flu
Xpert MTB/RIF
Xpert-EV

HOW IT WORKS


  • The test, run on Cepheid's GeneXpert systems, takes about 45 minutes to deliver results. The company said there are nearly 5,000 of the automated systems currently deployed throughout the U.S., with more than 23,000 around the world.
  • With point-of-care testing, FDA Commissioner Stephen Hahn said in a statement on Saturday ​results will be delivered to patients in "hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory" and will enable "patient access to more immediate results.” 
  • The device, named Gene Expert System was already approved for rapid diagnostic procedures for Critical-Infectious-Diseases
  • Xpert Xpress SARS-CoV-2 (EUA) Covid-19
  • Xpert Xpress Strep A
  • Xpert Xpress Flu/RSV
  • Xpert Xpress Flu
  • Xpert MTB/RIF
  • Xpert-EV
  • The test, run on Cepheid's GeneXpert systems, takes about 45 minutes to deliver results. The company said there are nearly 5,000 of the automated systems currently deployed throughout the U.S., with more than 23,000 around the world.
  • While tests from clinical lab networks LabCorp and Quest have significantly increased the nation's coronavirus testing capacity in recent weeks, those services require a healthcare provider to send specimens to an external facility. In addition, patients with a suspected case of COVID-19 do not receive confirmed results for at least a few days.
  • Another potential advantage of Cepheid's 45-minute test is that it can use a saline wash for testing if swabs are not available, according to the company. Some labs across the country are reporting a short supply of swabs, which are needed for collecting patient samples to test for coronavirus infection, as well as reagents.​
  • "The test cartridge is a complete solution containing all the necessary reagents," according to Cepheid​. "This is different from some other test kits on the market which may require additional reagents such as extraction materials."
  • FDA has updated its COVID-19 diagnostic testing FAQs, which now lists the clinical labs that are offering to test, the states that have chosen to authorize labs to develop and perform tests, as well as commercial manufacturers that are distributing test kits. ​
  • EMERGENCY USE AUTHORIZATION

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 


Coronavirus Disease 2019 (COVID-19) UPDATE





Cepheid wins 1st FDA nod for point-of-care coronavirus test | MedTech Dive: MedTech industry news