Chembio announces update on the FDA submission of DDP HIV-syphilis
Category: #health  By Pankaj Singh  Date: 2020-01-04
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Chembio announces update on the FDA submission of DDP HIV-syphilis

 

  • The developer and marketer of rapid diagnostic tests anticipates the FDA approval of its micro reader and multiplex test in the first quarter of 2020.
  • DPP HIV-Syphilis system developed by the company providers the detection of antibodies to HIV types 1 and 2, along with the detection of bacteria causing syphilis, Treponema pallidum.

Medford based leading diagnostics company, Chembio Diagnostics has reportedly provided an update on its premarket approval submission of DDP HIV- syphilis system to the Food and Drug Administration (FDA). Apparently, the company is anticipating the FDA approval of the system including the DPP HIV-Syphilis multiplex test and DPP Micro Reader mostly during the first quarter of 2020.

The company’s DPP HIV-Syphilis System is a one-time use test supporting the diagnosis of antibodies to the HIV type 1 and type 2 along with the detection of Treponema pallidum, the syphilis causing bacteria. The system makes use of a 10 microliter sample of venous whole blood, whole blood, or plasma. Moreover, the test is extremely sensitive and can be stored at room temperature, with a shelf life of 24 month.

Speaking on the matter, the CEO of Chembio, John Sperzel reportedly quoted that the clinical study conducted by the company with the enrollment of over 2500 subjects, represented that the DPP HIV-Syphilis System adhered to the performance requirements established with the Food and Drug Administration. He further stated that the company has provided the additional studies including the data on pregnant women, whose decision from the FDA is impending. 

With the co-infection rates of syphilis and HIV being on the rise throughout, the US Centers for Disease Control and Prevention has estimated that the individuals with an active syphilis infection carry over two to five fold increased chances of contracting HIV, when exposed to the virus. Furthermore, over two million pregnancies every year are affected by mother to child transmission of the HIV or syphilis infection, leading to high rates of stillbirth, low birth weight, perinatal death, and spontaneous abortion.
 

Source credit: http://chembio.com/news-and-events/press-releases/



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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