Roche Diagnostics: Molecular diagnostics
Q: What is the brand name of your molecular diagnostic technology for influenza?
cobas® Liat® PCR system
Q: How long has it been on the market?
The cobas Liat PCR system was introduced in 2014.
Q: CLIA certificate?
In the U.S., three tests are FDA-cleared to run on the system: Influenza A/B, Influenza A/B + RSV, and Strep A. All are CLIA-waived.
Q: Most logical call points
Healthcare providers who do a moderate to high volume of strep and flu testing are the best call points for the cobas Liat PCR system. The FDA reclassification of antigen-based rapid influenza detection test systems, or RIDTs, this past January will begin to be enforced in January 2018, and this is creating a sense of urgency among customers to provide better clinical performance at the point of care. Distributor reps can drive awareness of the FDA decision and leverage the opportunity to encourage customers to upgrade their in-office testing now with compliant technology and offer patients a better standard of care.
The specific types of settings that would find this technology the most attractive are pediatrics practices, multiphysician practices with family physicians or general practitioners, and urgent care clinics. Molecular POC testing that can deliver results in less than 20 minutes will also be useful in adult and pediatric emergency departments and retail clinics or pharmacy settings.
Q: Layperson’s description of how the technology works
The cobas Liat PCR system is essentially a molecular laboratory in a tube. It uses PCR technology to make copies of DNA or RNA from the patient sample and identify infectious diseases with lab-quality results in 20 minutes or less. The sample is a simple swab of secretions from the back of the nose for flu and RSV, or from the throat for strep.
What is perhaps most surprising about the system is how easy it is to use. It only takes about one minute of hands-on time once the patient sample has been collected. Then, the operator simply inserts the closed assay tube into the analyzer and starts the test. There are no additional reagent mixing steps required; the operator can simply walk away while the system performs the test. This provides even greater flexibility than physician offices have had to date with traditional antigen testing.
In 15 to 20 minutes, depending on the test, the caregiver has a definitive lab-quality result, with no interpretation required and no confirmation of negative results required, either. This is a big advantage, which can save caregivers time and help patients get appropriate treatment in a timely manner.
Q: Often-heard objections
• “Molecular tests cost more than rapid antigen tests.”
• “Molecular tests take longer to perform than RIDTs.”
Q: Responses to objections
Because the cobas Liat tests are molecular, the reimbursement codes associated with that type of testing are different than the ones for traditional rapid antigen tests. When molecular tests are covered, the Medicare reimbursement rates are higher. Private payers typically offer coverage, but in some cases their reimbursement rates may be less than the full Medicare rate. We would recommend that a practice reach out to their key payers to understand how the molecular codes are reimbursed.
Another factor to consider is the workflow savings a practice can see by having a reliable, accurate test result that they don’t have to interpret or send out for confirmation testing when they get a negative result. That can save them the labor time associated with the test send-outs and making calls back to the patients. It also creates a much better patient experience.
The distributor rep should ask the customer to examine the true amount of time their current test method takes. They should be sure to take note of steps that must happen at specific times and include any follow-up work that’s needed.
The tests on the cobas Liat system only take 15 to 20 minutes, yet they provide lab-quality PCR results. Sure, that’s slightly longer than an antigen-based RIDT, but the hands-on time of test preparation for the cobas Liat system is only one minute. After that, the operator has the flexibility to walk away and return to the result when it’s convenient. With traditional testing and other options on the market, the operator needs to perform certain follow-up steps at specific times and often has additional sample preparation steps to complete. Perhaps even more important, the time the customer spends in getting a confirmatory test for a negative RIDT result can add significant staff time for coordination, patient phone calls and more.
Q: Other pertinent points for reps to be aware of
As with any switch in testing methodology, it’s important for distributor representatives to prepare customers for a smooth transition. While the cobas Liat system is very easy to use, their staff will need to have device training and will likely want to alter their workflow to manage patients who present with flu, strep and RSV symptoms. Overall, this should be a very positive change – because having the freedom to walk away from the instrument and having more accurate, actionable results will free staff up from low-value, time-consuming chores.
However, it will take some time. So getting customers started down the process sooner rather than later is critical to helping them be ready for this year’s respiratory season. Distributor reps should work closely with their manufacturer’s sales partners to help ensure a smooth transition.
It may also helpful for customers to know that PCR has been used in diagnostic testing for more than 20 years and is recognized as a gold standard in laboratory diagnostics.