NEW YORK (GenomeWeb) – Lucigen is continuing to develop a point-of-care molecular diagnostic platform with an initial assay designed for Clostridium difficile detection. The firm described the platform and preliminary results of trials using a prototype yesterday at Cambridge Healthtech Institute's Next Generation Dx Summit in Washington, DC.
Called ClariLight, the platform will use Lucigen's OmniAmp isothermal nucleic acid amplification polymerase as the core technology, Hemanth Shenoi, vice president of business development and diagnostics at the Middleton, Wisconsin-based company, told GenomeWeb in an email.
The OmniAmp enzyme is a thermostable viral DNA polymerase that enables one-step, single-enzyme, reverse transcriptase PCR, as previously described.
In his presentation at the summit, Shenoi showed the results of a small, 50-patient study done in collaboration with the Marshfield Clinic in Wisconsin.
The study compared a prototype ClariLight C. diff test to the US Food and Drug Administration-cleared Quidel C. difficile test the clinic regularly uses.
"The results demonstrated 100 percent sensitivity and 98 percent specificity as compared to the reference test," Shenoi said, adding that the firm expects to see some drop off in performance during formal clinical trials but is "very pleased with the early pre-clinical performance data."
The polymerase "has several unique properties that make it exceptionally well suited for CLIA-waivable point-of-care molecular diagnostics," Shenoi said.
These include high thermal stability, the ability to be stably formulated into dry master mixes, and the ability to perform both RNA- and DNA-dependent nucleic acid amplification.
Lucigen is continuing development of an Ebola assay that uses the AmpliFire portable thermal cycler from Douglas Scientific. The firm is also collaborating withDouglas on other "PCR-tube based format" tests, Shenoi said.
The ClariLight instrument, meanwhile, is being developed in-house by Lucigen and will "uniquely fit the reagent cartridges we have designed in combination with the instrument," Shenoi said.
Both instruments are designed for isothermal amplification and fluorescence detection and use OmniAmp nucleic acid amplification reagents.
The point-of-care diagnostics space has become more crowded recently. The Alere i and Roche Liat platforms have been FDA-cleared and CLIA waived, and a new platform from Cepheid, the Omni, is expected to be launched next year.
The pipelines for these platforms have some commonalities, with influenza and Strep A assays in the front of the line. Both Roche and Alere are also developing C. diff assays.
But it is early days in the emergence of CLIA-waived molecular diagnostic products and there is room for multiple players, Shenoi asserted.
Lucigen decided to focus its efforts on hospital-acquired infections, specifically C. diff, because of the clarity of the regulatory process, the lack of seasonality in incidence, and the fact that reimbursement is in place with a specific molecular CPT code, he said.
"Not only is the flu and Strep A market very crowded, we don’t believe that seasonal illnesses are a good place to start our point of market entry," Shenoi said.
According to Lucigen's analysis, there are over 6 million C. diff tests being performed today, with a market opportunity of greater than $100 million and a consistent 10 to 20 percent incidence across symptomatic patients occurring year round.
The firm's target customer base will be a mixture of emergency rooms, nursing homes, and some physician offices, "a different sub-segment compared to Alere and Roche," Shenoi noted.
The key technical differentiator of ClariLight from either of those products is the potential to simultaneously perform RNA- and DNA-dependent nucleic acid amplification from a single patient sample.
Although the C. diff test does not take advantage of this property of the system, Shenoi said it will ultimately allow Lucigen to create small panels of up to 16 analytes in the future, "to deliver a more complete picture of the patient's health."
"We also believe that we can manufacture both our instrument and cartridges for a much lower cost, giving us the ability to bring more value to the market," he said.
Lucigen had previously stated that it would be entering full clinical trials for the C. diff assay in the second half of this year.
"We are currently refining our project plan and will have an update on the timing of our clinical trial at a later date," Shenoi said, adding that the firm remains committed to conducting a single trial to satisfy the requirements of a dual 510(k) and CLIA-waiver submission.