INDIANAPOLIS--(BUSINESS WIRE)--SpectronRx announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the HymonTMSARS-CoV-2 Test Kit, featuring specific clinical benefits:
- 1.5-hour testing time, from prep to finish;
- 94 sample capacity (+ controls) per kit;
- LOD (Limit of Detection) of 1.2 copies of SARS-CoV-2 RNA/uL = 5 copies per reaction;
- Low laboratory footprint requirement.
The HymonTMSARS-CoV-2 Test Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
“We are excited to contribute to the global battle against coronavirus by providing an efficient, real-time diagnostic PCR test to detect SARS-CoV-2,” said John Zehner, CEO of SpectronRx. “The shortage of tests nationwide has hindered proper diagnostic assessment of health in our communities – we are bringing testing to our communities, and hoping our contribution elevates the standard of diagnosis and provides a clear path of epidemiologic assessment during our ongoing fight against coronavirus.”
The PCR test can be performed on Applied Biosystems 7500 PCR systems, providing rapid results in a wide range of healthcare settings such as diagnostic labs and hospitals in the US, and can also be utilized in mobile or rural environments. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests. SpectronRx and its partner, HymonBio, expect to produce 10 million tests per month for laboratories around the world.
SpectronRx is a Contract Development Manufacturing Organization (CDMO) based in Indianapolis, Indiana focused on diagnostic and therapeutic solutions for the pharmaceutical industry (clinical and commercial pharmaceutical supply, with special focus on radiopharmaceuticals), as well as nucleic acid testing of coronavirus. More information can be found at spectronRx.com, or by connecting with SpectronRx on LinkedIn.
HymonBio is a high-tech biotechnology company with expertise in molecular testing and in-vitro diagnostics. HymonBio executive management is composed of professionals from the IVD industry with PhDs from prestigious US institutes. The company specializes in solutions for the IVD industry with more than 80 registrations globally.
This test has not been FDA cleared or approved; This test has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.