Verséa Ophthalmics, a division of Verséa Health, Inc., has begun shipping initial units of two products: the Tear-based Point-of-Care (T-POC) TOTAL Immunoglobulin (IgE) Immunoassay Kit and Lateral Flow Readers.
Refresh me on the company.
Verséa Health is a U.S.-based healthcare company focused on providing personalized clinical and therapeutics in eye care, including diagnostics and biologic solutions for diagnosing, treating, and managing ocular conditions such as ocular surface disease (OSD) and pterygium surgery.
Define lgE.
Immunoglobulin E (IgE) is an antibody produced by the immune system that binds to allergens which can increase with the severity of an allergic response.
To note, testing for and identifying the presence of lgE can indicate a diagnosis of allergic conjunctivitis.
Now talk about this testing platform.
The FDA-approved, novel test platform is designed to diagnose and manage OSD patients as well as measure the actual levels of IgE—giving the clinician a numerical value to differentially diagnose a patient’s condition and allow for informed prescribing decision.
Go on …
Developed and manufactured by AXIM Biotechnologies, Inc., the tests are meant to be performed with ease, accuracy, rapidity, repeatability, and are reimbursable.
According to the company, if the test is repeated after initiating therapy, it could potentially confirm the desired therapeutic response.
Which ocular areas does it focus on?
Per Verséa, the platform is currently being used for dry eye, ocular immunology, ocular allergy, and ocular surgery.
What types of tests are provided?
The T-POC TOTAL lgE Immunoassay test provide results in less than 10 minutes, focusing on lgE as an allergic conjunctivitis biomarker:
- Sample size and type: 0.5 µL in tears
- Test results:
- Normal lgE: < 80 ng/mL
- High IgE: > 80 ng/mL
- Very High IgE > 300 ng/mL (could be indicate of vernal keratoconjunctivitis and might warrant a systemic workup)
- Sensitivity: 93%
- Specificity: 96%
- Shelf life: 12 months
So just one test is available?
For now, yes. But this is just phase 1 of the company’s launch …
According to Verséa, phase 2 of the launch will include shipment of the platform’s newest platform: the T-POC LACTOFERRIN (Lf) Immunoassaytest—a quantitative test for aqueous-deficient dry eye disease (DED).
To note, Lf is a protein (with antimicrobial and anti-inflammatory properties) and key biomarker for distinguishing aqueous-deficient DED from evaporative DED.
What does this test include?
Similar to the lgE test, the T-POC LACTOFERRIN Immunoassay test gives results in less than 10 minutes as well as the following:
- Sample size and type: 0.5 µL in tears
- Test results:
- Normal Lf: > 0.9 mg/ml
- Low Lf: < 0.9 mg/mL
- Sensitivity: 83%
- Specificity: 98%
- Shelf life: 12 months
When might it be available?
According to the company, shipments of the Lf test (and, as a result, the launch of Verséa's phase 2) are expected to be sent out in the next few weeks.
Are these tests billable?
Indeed they are. The T-POC testing is billable with the following CPT codes:
- lgE allergy test → CPT code 82785
- Lf test → CPT code 83520