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Medical equipment industry

Diagnostic Hybrids, Inc. Receives FDA Approval for New HSV Test Kit

Strategic Insights

— 1 min read

Diagnostic Hybrids, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Enzyme Linked Virus Inducible System (ELVIS) HSV Test Kit for in vitro diagnostic use in identifying herpes simplex virus (HSV) from clinical specimens. The new kit utilizes transgenic mammalian cells incorporating viral and bacterial genes to signal the presence of infectious HSV through a color change, providing a simplified and accurate diagnostic method.

Key Takeaways:

  • The ELVIS HSV Test Kit contains transgenic mammalian cells that incorporate viral and bacterial genes to detect HSV, reducing the time and labor involved in isolating and detecting the virus.
  • The kit identifies both types of herpes simplex virus: HSV-1, commonly associated with cold sores, and HSV-2, usually causing genital herpes.
  • In clinical trials, the ELVIS HSV Cells were shown to give highly accurate results, reducing the time to obtain confirmed results from seven days to less than one day.
  • The ELVIS technology was developed by Paul D. Olivo, M.D., Ph.D., of the Washington University School of Medicine, in collaboration with Diagnostic Hybrids, Inc.
  • The new kit is the 10th clinical virology product to gain FDA approval from Diagnostic Hybrids, Inc.
  • The company plans to utilize its in-house manufacturing and marketing capabilities for sales of the new kit to hospital clinical labs and commercial reference labs in the U.S. and establish partnerships for sales abroad.
  • The ELVIS HSV Test Kit has been demonstrated to decrease the time it takes to obtain confirmed results from as long as seven days to less than one day.
  • The kit presents no unusual manufacturing challenges, allowing Diagnostic Hybrids, Inc. to meet the anticipated demand for this new product.

Statistics:

  • The ELVIS HSV Test Kit identifies both HSV-1, commonly associated with cold sores, and HSV-2, usually causing genital herpes.
  • The kit reduces the time to obtain confirmed results from seven days to less than one day.
  • The ELVIS technology has been shown to give highly accurate results in clinical trials.

Sources:

  • "Diagnostic Hybrids, Inc. Receives FDA Approval for New HSV Test Kit." PRNewswire, May 1, 1995.
  • Diagnostic Hybrids, Inc. press release.

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