Today FDA government officials has approved these two companies Cytosorbents (CTSO) and SCWorx (WORX) on blood purification and testing for the coronavirus.
SCWorx (WORX)
SCWorx Corp. (Nasdaq: WORX) announced today that it has received a committed purchase order from Rethink My Healthcare, a U.S.-based virtual healthcare network, for two million COVID-19 Rapid Testing Units, with provision for additional weekly orders of 2 million units for 23 weeks, valued at $35M per week.
Under the Order, SCWorx will supply Rethink My Healthcare with IgM/IgG Rapid Detection Kits. SCWorx anticipates receiving the first 2 million rapid detection kits within approximately two weeks.
“Widespread testing for COVID-19 disease in the United States is absolutely critical for saving lives and reopening our economy,” said Marc Schessel, CEO of SCWorx. “Our substantial purchase order from Rethink My Healthcare will significantly increase the availability of rapid-test kits in the United States. Additional purchase orders currently under negotiation with certain other parties could further increase the U.S. supply of these important tests in the near term.”
The COVID-19 Corona Virus IgM/IgG Rapid Test is an in-vitro diagnostic test solely for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood, serum, plasma and fingertip blood. This IgM/IgG Rapid Detection Kit is the world’s first device that tests for both IgM and IgG antibodies with proven good clinical performance compared with RT-PCR.
Under regulatory guidelines, the Rapid Detection Kit is for professional use only and can be used in Centers for Disease Control and Prevention, Primary Health Care Institutions, Government Department / Public Institution State-Owned Enterprise / Large Company, Industrial Production Enterprise, Schools and/or Prison / Detention Center/ Drug Rehabilitation Center.
Cytosrobents (CTSO)
According to a letter from the FDA,
On February 4, 2020, pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (the Act), the Secretary of the Department of Health and Human Services (HHS) determined
that there is a public health emergency that has a significant potential to affect national security
or the health and security of United States citizens living abroad, and that involves the virus that
causes COVID-19.
Pursuant to section 564 of the Act, and on the basis of such determination,
the Secretary of HHS then declared on March 24, 2020, that circumstances exist justifying the
authorization of emergency use of medical devices, including alternative products used as
medical devices, due to shortages during the COVID-19 outbreak, pursuant to section 564 of the
FD&C Act, subject to the terms of any authorization issued under that section.There are no FDA approved, licensed, or cleared device treatments for COVID-19. Based on
bench performance testing and reported clinical experience, FDA has concluded that the
CytoSorb device may be effective at treating certain patients with confirmed COVID-19 by
removing various pro-inflammatory cytokines from their blood. FDA believes, based on the
totality of scientific evidence available, that the removal of pro-inflammatory cytokines may
ameliorate cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn,
provide clinical benefit.
