Alere: Molecular diagnostics
Q: What is the brand name(s) of your molecular diagnostic technology for influenza?
Alere™ i Influenza A & B
Q: How long has it been on the market?
The Alere™ Influenza A & B received FDA clearance in 2014.
Q: CLIA certificate?
Alere™ Influenza A & B was first CLIA-waived molecular platform in January 2015.
Q: Most logical call points?
Primary Care, Pediatrics, Hospital Laboratory, Urgent Care.
Q: Layperson’s description of how the technology works
Alere I is a molecular technology (amplifies the sample up to a billion times), providing highly accurate results in 13 minutes from a direct nasal swab.
Q: Often-heard objections
• “I am unsure of the benefits of molecular testing in the physician office.”
• “Is the additional cost of molecular worth the clinical benefits?”
• “Molecular testing will slow my workflow down.”
Q: Responses to objections
• Point of care molecular testing offers the clinician the best options to treat their patients. The Alere ™ I provides highly accurate molecular results in 13 minutes from a simple nasal swab, giving clinicians the right result at the right time.
• Molecular testing does have a higher cost per test, but can be implemented in any office setting without the need of a capital investment. The molecular reimbursement using CPT code 87502 usually offers higher coverage than lateral flow testing. Customers have access to reimbursement information by state through www.Codemap/Alere.
• All antigen tests carry a recommendation to back up negative results with culture or an FDA-approved molecular assay. The Alere ™ i does not carry that recommendation for flu, and if needed, can be used to back up a negative lateral flow test.
• Traditional PCR testing does take longer to run; the Alere ™ i provides a molecular result in the same time or faster than most CLIA-waived lateral flow tests.
Q: Other pertinent points for reps to be aware of
• AlerePALS.com is a great resource for customers and patients for further education on advantages of molecular testing.
• Molecular testing is not impacted by the FDA flu reclassification, is already a Class II device, and provides highly accurate CLIA-waived results in 13 minutes from a direct nasal swab.
Alere: Lateral flow testing
Q: What are the brand name(s) of your lateral flow testing technologies for influenza?
• Alere BinaxNOW® Influenza A & B Test
• Alere BinaxNOW® Influenza A & B Card 2
• Alere™ Reader
• Alere™ Influenza A & B Test
Q: How long have they been on the market?
• The Alere BinaxNOW® Influenza A & B Test achieved CLIA waiver 2004.
• The BinaxNOW® Influenza A & B Card 2 assay is the first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA reclassification requirements.
• The BinaxNOW® Influenza A & B Card 2 assay with Alere™ Reader interpretation is targeted to launch in later 2017. CLIA waiver is pending FDA clearance.
• Alere ™ Influenza A & B Test, a dipstick format, achieved CLIA waiver 2011.
Q: CLIA certificates?
• Alere BinaxNOW® Influenza A & B Test is CLIA-waived.
• The BinaxNOW® Influenza A & B Card 2 assay with AlereTM Reader interpretation is targeted to launch in later 2017. CLIA waiver is pending FDA clearance.
• AlereTM Influenza A & B Test is CLIA-waived
Q: Most logical call points
• Physician Office: Clinician, Office Manager, Nurse, Laboratory.
• Urgent Care Centers: Clinician, Office Manager, Nurse, Laboratory.
• Hospital: Microbiology Laboratory, Laboratory Director/Manager, Point of Care Coordinator, Emergency Room for POC placement.
Q: Layperson’s description of how the technology works
• The Alere influenza portfolio offers flexibility in a range of platforms to support customers’ needs, including: Molecular, Reader, and Visual technologies.
• The Alere BinaxNOW® Influenza A & B assay workflow: A nasal/NP swab is collected and added to the test card. The sample flows across the device and is visually read at 15 minutes.
• The AlereTM Influenza A & B assay’s workflow: A nasal swab is collected and added to the test device. The sample flows across the device and is visually read at 10 minutes.
• The AlereTM Reader will interpret, capture and transmit results of select Alere rapid lateral flow tests and can be used in the laboratory and point of care settings.
• The Alere BinaxNOW® Influenza A & B Card 2 assay’s workflow: A nasal/NP swab is collected and added to the test card. The sample flows across the device and is placed in the AlereTM Reader for interpretation at 15 minutes.
Q: Often-heard objections
• “The BinaxNOW® Influenza A & B assay does not meet reclassification.”
• The BinaxNOW® Influenza A & B Card 2: No objections at this time due to future launch date.
• Alere™ Reader: No objections at this time due to future launch date.
Q: Responses to objections
• The Alere BinaxNOW® Influenza A & B assay is the most used lateral flow influenza test available, and any product purchased through Jan. 12, 2018, can be used through the shelf life of the test.
• The BinaxNOW® Influenza A & B Card 2: N/A
• AlereTM Reader: N/A
Q: Other pertinent points for reps to be aware of?
• The BinaxNOW® Influenza A & B Card 2 assay is also pending FDA approval for a CLIA-waived, visual interpretation claim. Timeline targeted for early 2018, pending FDA clearance.
• The Alere dipstick offers a familiar visual read format that exceeds reclassification requirements.