chesco vs advaite amended-complaint…..

Remember that story? Of the Malvern Company and the COVID tests? An amended complaint has been filed by Chester County:

JANUARY 20, 2021 Philly Voice: Chester County sues East Whiteland company for $11 million over missing COVID-19 antibody tests
The lawsuit claims Advaite failed to deliver the 1 million tests it promised, the lawsuit states

Philadelphia Inquirer: Chester County spent $13 million on coronavirus antibody tests. Then it quietly shelved the program.
Internal emails and interviews show that the newly developed, unapproved tests, sold to the county by neophyte biotech firm Advaite, may have produced wildly inaccurate results.
by Marie McCullough and William Bender
Updated Sep 17, 2020

BUT…..this company as of March, 2021 is advertising a rapid test through Amazon Business anyway?

ADVAITE Now Offers FDA EUA RapCov™ Rapid COVID-19 Tests Through Amazon Business
Advaite’s “RapCov™” Testing Kit offers convenient and rapid screening solutions for millions of business customers, with expanded access for authorized facilities to purchase via Amazon Business

NEWS PROVIDED BYAdvaite Inc. 

Mar 18, 2021, 09:00 ET

MALVERN, Pa., March 18, 2021 /PRNewswire/ — ADVAITE’s RapCov™ Rapid COVID-19 Test, one of the first US manufactured FDA EUA authorized point-of-care (PoC) serology tests, is now available via Amazon Business.

The FDA’s Emergency Use Authorization (EUA) for Advaite’s rapid response IgG antibody test strengthens America’s public health protections against biological threats by facilitating availability and use of cutting-edge medical countermeasures. ADVAITE is one of the only US manufacturers to receive FDA EUA for a point-of-care serology test to date. All RapCov™ Rapid COVID-19 Test Kits are manufactured and assembled locally start to finish at FDA registered facilities in Southeastern Pennsylvania.

“This is a very important moment for public health in fighting this pandemic,” said Karthik Musunuri, Chief Executive Officer of Advaite. “The ADVAITE RapCov™ Rapid COVID-19 Test offers unique advantages in containing the disease. Advaite’s test is simple to use, provides accurate results from a drop of fingertip blood and can detect IgG antibodies to the COVID-19 virus. Perhaps, most critically, our tests provide results in 15 minutes at the point of care. The inclusion of this test to be made available via Amazon’s online store will allow for expanded accessibility of the test to authorized providers.”

FDA GRANTS ADVAITE EMERGENCY USE AUTHORIZATION FOR RapCov™ Rapid COVID-19 Test
MALVERN, PENNSYLVANIA, USA, January 12, 2021

The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE Inc., an innovative biotech company developing novel point-of-care assays to help with combatting COVID-19.

The federal government’s EUA for ADVAITE’s rapid response IgG antibody test will strengthen America’s public health protections against epidemiological threats by facilitating access to cutting-edge medical countermeasures, such as ADVAITE’S RapCov™ Rapid COVID-19 Test. ADVAITE is one of only a handful of US manufacturers to receive EUA for a point-of-care serology test.

“This is a watershed moment in the fight against this pandemic,” said Karthik Musunuri, Chief Executive Officer of Advaite. “The RapCov™ Rapid COVID-19 Test offers unique advantages in containing the virus. ADVAITE’s test is simple to use, provides accurate results from a drop of fingertip blood and can detect IgG antibodies to the COVID-19 virus. Perhaps most critically, our tests provide results in 15 minutes at the point-of-care.”

“Fifteen-minute testing can mean peace of mind and workforce readiness,” Musunuri said, emphasizing that, “Unlike conventional tests that require offsite blood specimen lab work, the RapCov™ Rapid COVID-19 Test analysis can be done on the spot at the point of care, such as at a physician’s office, making this an ideal solution for screening mass populations.”

From a public health perspective, the RapCov™ Rapid COVID-19 Test will help in seroprevalence surveys for determining the prevalence of infection in communities during the COVID-19 pandemic. “Our test uses fingerstick whole blood in point-of-care settings, thereby offering a practical and scalable approach to estimate prevalence of persons who develop SARS-CoV-2 antibodies in a more general population and over repeated time intervals.” said Dr. Sandeep Jain, ADVAITE’s Chief Scientific Officer.

All RapCov™ Rapid COVID-19 Test Kits are manufactured and assembled start to finish at FDA registered facilities in Southeastern Pennsylvania, and ADVAITE plans to immediately begin supplying the market with its testing kits on a national scale.

So what about whatever they promised to Chester County?

Truly life in the land of COVID will make for several good whodoneits by the time life returns to normal….

Documents disclosed obtained via a Right to Know are kosher to peek at even for us ordinary folks, correct? And a court filing also ok to peek at, correct?

Most of this is waaaay above my pay grade but I thought I would share…..

Chester County…..get out the popcorn….

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