Detecting infections quickly, accurately is goal of new testing platform

Lucigen product in development would reduce wait time for lab results, improve patient outcomes.

“Fast or accurate” is not a choice that medical professionals should have to make when conducting critical infectious disease testing. And with promising new product development being done by Wisconsin-based Lucigen Corp., that dilemma may be a thing of the past.

Lucigen plans to change the way infectious disease diagnostics are performed by creating a fast, economical testing platform that can be used in a point-of-care setting while still achieving the superior sensitivity and specificity of laboratory-based molecular diagnostics. The company’s solution aims to significantly improve patient outcomes while decreasing overall health care costs.

“Physicians today must choose between rapid, simple and inaccurate point-of-care tests or slow, complex and accurate lab molecular tests,” said David Mead, founder and CEO of Lucigen, a biotechnology company that specializes in life science research tools and advanced genomic and proteomic custom services. “We are developing a simple testing platform that will provide lab-quality molecular diagnostic accuracy in minutes instead of hours.”

It would be the first molecular diagnostic test with a 510(k) point-of-care intended use providing rapid infectious disease testing suitable for use in a doctor’s office, emergency room, nursing facility or clinic.

The Madison company’s first test for the diagnostic platform will check for Clostridium difficile (C. diff), a bacterial infection that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. More than 500,000 become sick from C. diff annually, and about 14,000 die from the infection, which is considered one of three “urgent threat level organisms” by the federal Centers for Disease Control and Prevention.

Additional tests may include detection of the influenza A/B virus, the respiratory syncytial virus (RSV), Group A strep (GAS), Group B strep GBS, enteric pathogens and sexually transmitted infections (STD).

“This high-quality point-of-care testing has the potential to improve quality of care while reducing costs,” Mead said. “It will be able to provide test results in 15 to 30 minutes, which will result in early diagnosis, early treatment and—most important—better outcomes for patients.”

The diagnostic platform includes an instrument that performs lysis, amplification and detection using a disposable cartridge for containing and mixing the sample with proprietary reagents. Because of the simplicity of the platform, Lucigen is designing it for CLIA-waiver, a diagnostic test classification given to products where the testing is “so simple and accurate as to render likelihood of erroneous results by the user negligible”.

No mixing, measuring or manipulation will be required on the part of the user, and the test can be conducted by health care providers whose primary training is not in the clinical lab sciences.

The platform incorporates patented nucleic acid amplification technology, OmniAmp™ Polymerase, for loop-mediated isothermal amplification (LAMP). Pre-clinical studies show sensitivity and specificity that meets or exceeds real-time PCR. An FDA clinical trial is planned in first half of 2015.

The company is actively seeking a commercialization partner and/or investors to support the approval and commercialization process.

(August 2014)