Efficient and Reliable for COVID-19 Testing
With the advent of the worldwide pandemic threat caused by COVID-19, GeneSTAT Molecular Diagnostics (GMD) pursued and secured a license option for the TGen-developed GEN 2 assay for the SARS-CoV-2 virus that causes COVID-19. GMD provides two test options:
- High throughput testing with GMD’s INSPECT COVID-19, 96-well test format for high volume screening
- Low throughput, point of need testing with the GeneSTAT.MDx COVID-19 self contained cartridge test
This GEN 2 test is designed to target ancient, highly-conserved regions on the DNA of the organism, meaning fewer variables, better specificity, and increased efficiency.
Definitive Results in 60 Minutes Without Culture
GMD’s SARS-CoV-2 (COVID-19) rRT-PCR test is specific for the two different genes, known as the N gene and the S gene, for the SARS-CoV-2 virus. It is a novel (patent pending) assay that in about 60 minutes identifies and differentiates not only pandemic COVID-19, but also other Coronaviruses (including endemic MERS). There is currently no rapid molecular test for screening or diagnostics capable of this differentiation, either alone or as co-infections.
Adding to its efficiency is the fact that our test requires only 1 test well per sample, enabling a 96-well cartridge to test 96 patients at one time. Current testing methods require the use of 2 to 3 wells to complete the test on one sample, meaning that a 96-well cartridge can test only 32 to 48 samples at once.
GMD’s SARS-CoV-2 (COVID-19) test complies with the CDC recommendations for collecting and testing human respiratory (nasopharyngeal and oropharyngeal swabs), and lower respiratory (sputum) initial diagnostic testing for COVID-19.