Selah to provide testing services for women's health

EKF Diagnostics announces that Selah Genomics, Inc., its wholly owned subsidiary based in South Carolina, US, has signed an agreement with a US national sales organization to provide testing services for a new suite of women’s health-focused molecular assays. The agreement will provide a new and reliable source of revenues from a panel of well-established reimbursed tests.

The US national sales organisation has an established customer base of clinicians who currently use tests from their panel of women’s health tests. Under the agreement, these women’s health tests will now be tested using Selah’s CLIA-certified laboratory in Greenville, South Carolina, and the panel will be expanded to include the Roche cobas® HPV Test, which has been running in Selah’s laboratory for the last two years. The Roche cobas® HPV Test, which tests for a DNA virus that can cause cervical cancer, is the only HPV test that is FDA-approved for ASC-US triage, co-testing, and first-line primary cervical screening.

The women’s health panel will offer clinicians the opportunity to test samples for HPV and PAP (used for cervical screening), as well as Chlamydia, Herpes, Trichomoniasis, and Vaginosis/Vaginitis.

Adding these new testing services adds a new line of revenue for Selah. It focuses on an area of women’s health that enjoys FDA-approved assays and stable reimbursement levels by Medicare and private payers. The reimbursement levels are expected to range between US$90 and US$450 per sample, depending on how many tests within the panel are required by the clinician. The Company expects over 1,000 samples to be tested monthly based on current run rates.

Julian Baines, CEO of EKF, commented: “Clinicians are increasingly turning to the power of molecular genetics for early and accurate diagnoses of disease, and our CLIA-certified laboratory is ideally suited to undertake these tests. Selah’s molecular assays used in the area of women’s health are an entirely new revenue stream for the Company and allow us to diversify into an FDA-approved area that has a stable reimbursement model and is a further extension of our growing portfolio of tests that offer a blend of reimbursement revenue.”