Hema Diagnostic Systems LLC said on Monday that it has filed a patent for the Express II, its new diagnostic qualitative point-of-care platform.

The company said the Express II is designed to be used in both professional medical settings and for direct home use by consumers and can be employed for the detection of a wide range of analytes in whole blood samples obtained by a simple finger stick, or with plasma or serum samples in clinical laboratories. Analytes that can be measured by this new device include antigens or antibodies and protein biomarkers which are found in infectious diseases, metabolic diseases and in a host of other medical conditions.The results of any assay conducted using the Express II platform are available in 15-20 minutes.

Effective immediately, the company plans to use the Express II platform as the basis of its newly-developed Express II Syphilis Treponemal Antibody Assay, followed by the integration of its other infectious disease assays into the Express II. Syphilis has reemerged as a major sexually transmitted disease.

Additionally, the company is on schedule to receive the CE mark for the Express II Syphilis Treponemal Assay in the Fall of 2018, which will allow its marketing in the EU. It will submit a 510(k) application to the US FDA for marketing clearance in the US as well as will pursue regulatory clearance in China.

Hema Diagnostic Systems LLC is a subsidiary of Generex Biotechnology Corporation (OTCQB:GNBT), a biopharmaceutical company.