Fecundation – sperm cell entering in ovum
One year after diagnostics startup Episona made its male fertility testing kit available to fertility clinics, the company is adding an on-demand testing service for the consumer market, according to a news release.
Despite the on-demand nature of the service, physicians will still evaluate those online requests for Seed and will order the test if appropriate.
Here’s how the service will work. Consumers can order a testing kit online and receive it in the mail within three to five business days. They provide a semen sample and send it to Episona’s CLIA-certified lab for review. Consumers and the ordering physician receive a two-part report online within three weeks with an assessment of the patient’s risk for male factor infertility, according to the release.
Seed is a next-generation sequencing test that identifies signs of DNA methylation in sperm as the result of aging, smoking, pollution and other factors. Depending on how and where this occurs, the DNA modifications can impact fertility and embryo development.
In an interview last year, Episona President and CEO Alan Horsager said that Seed would be offered as a first-line diagnostic before couples commit to costly fertility treatments. But as with most diagnostics in this space, Horsager said Episona’s test is not covered by insurance. Patients must pay the $495 cost out-of-pocket, on top of the usual battery of tests.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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Correction: An earlier version of this story misspelled the company name, Episona. We regret the error.
