The stock of Chembio Diagnostics Inc (NASDAQ:CEMI) closed at $7.70 gaining 0.65% in yesterday’s trading session. Chembio Diagnostics has already completed its most recent clinical trial that targeted evaluating its DPP® HIV-Syphilis System.
At the moment, it has plans underway to file for a Pre-Market Approval (PMA) submission. That will of course be with the Food and Drug Administration (FDA) and will be happening in the first quarter of 2018.And will be aimed at helping support the commercialization of the first POC HIV-Syphilis assay in the U.S.
The Chembio DPP® HIV-Syphilis System is made up of the DPP® Micro Reader and the DPP® HIV-Syphilis Assay and it plays a huge role helping detect antibodies to HIV types 1 and 2 and syphilis Treponema pallidum. The tests are conducted in such a way that they need to be conducted at room temperature and are associated with a 24-month shelf life. Basically, the tests are conducted using a small 10 µl fingerstick blood sample which is quite specific in nature and highly sensitive at the same time.
Chembio’s Chief Executive Officer John Sperzel opined, “The U.S. clinical trial designed to evaluate the accuracy of the DPP® HIV-Syphilis System resulted with sensitivity and specificity that met the study objectives of the clinical protocol. The results of the clinical trial will be filed with the PMA submission for review by the FDA.”
He went ahead to outline that Chembio had been aggressively pursuing a three-pronged growth strategy that concerned itself with the consolidation of the sexually transmitted disease business. As a company they have lately been paying a lot of attention to towards the development of the fever disease portfolio as well as in strengthening of their technology collaborations.
The official revealed that the Commercialization of the DPP® HIV-Syphilis Assay in the United States was a major part of their business strategy. It goes without saying that the completion of the U.S. clinical trial was going to help much towards ferrying the novel product much closer to the market. The company is looking forward to unveil the DPP® HIV-Syphilis System in the U.S market but that will only take place after FDA proceed to give its approval.