The story could have helped men read between the lines of the company’s touting of the debut of this “first at-home test.”
Instead, it tended to parrot the same claims that the company CEO and chairman made, with no independent expert perspective and no independent journalistic critical analysis of its own.
Comparing the at home test to a standard semen analysis conducted by a physician is a bit of a stretch. While perhaps embarrassing and inconvenient, the standard test not only provides sperm count but also important factors such as motility, vitality and total count. Despite its FDA approval, the SpermCheck test only provides a portion of the information necessary for a complete evaluation. In addition the standard test is usually conducted twice, several weeks apart since sperm count varies considerably. If it is, indeed, a $440 million-a-year market for male fertility tests, as the story allows the company CEO to say, then perhaps the role of journalism in this case would be to critically evaluate the competing products – something this story didn’t do – starting with the fact that it didn’t explain that the product was approved by the FDA’s 510K “substantially equivalent” process and provide an accurate description of the office based testing.
The story states that the cost of the test will be $39.99.
Although the story does provide information about the cost of the test (which may have come directly from a news release), it fails to note that the standard approach requires two separate tests as established by the World Health Organization. At a minimum then the real cost of the test is $80.
The story – with copy that sounds like it came from an ad agency – claims the test “…assesses sperm count with 98% accuracy in 10 minutes and does away with the unpleasantness of conjuring up a sperm sample in a doctor’s office
In fact, compare that line with this copy from the company’s news release:
“In just 10 minutes …It’s more than 98% accurate – as reliable as a lab test – yet much more convenient and at much less cost than a visit to the doctor. It also alleviates the embarrassment and inconvenience of providing a semen sample to a doctor or nurse in a lab setting.”
While there is a general relationship between sperm count and fertility, the equation is not quite that simple. The test may accurately provide a sperm count but that single piece of information is not sufficient to make assumptions about the ability to induce pregnancy. See “Harms” criterion below.
The specificity of the test was not discussed; it was 94% according to FDA documents. It’s only half the story to tell what the sensitivity was. Sensitivity doesn’t tell you about false-positive results, and specificity does not tell you about false-negative results. Why not report both?
In addition, a test that tells you about sperm count doesn’t necessarily tell you anything about sperm quality – another part of the picture. So any man who truly wants the complete picture would need to see the doctor anyway. This isn’t exactly a “harm” but it is part of the reality that a news story should have reported – or else men may feel drawn in by the story’s promotional tone, not realizing the full ramifications of the “debut” of this “first at-home test.”
The headline and story tout “the first at-home infertility test”. And, yes, the FDA approved this test. But we think the story should explain that it won the approval in the FDA’s 510K process, meaning it was judged to be only “substantially equivalent” to a bunch of other approaches already on the market.
We also think that a complete story would have provided the limitations of the at home test especially since the story suggests it is the equivalent to a trip to the doctor. It clearly is not.
One definition of disease-mongering includes the attempt to expand the market for diagnoses – and for products that address those diagnoses.
This story allows the chairman of SpermCheck to say. “This at-home test was created to meet the needs of couples who are considering and just planning on starting a family, those currently having trouble conceiving” and “even those men who are just curious about their sperm count.”
This plants the seed of expanding the market for the test to “the curious” – a potentially unlimited market. Nice – if you’re a company chairman. Less than independent vetting – if you’re in journalism.
There is no independent perspective in the story. The only sources quoted are the CEO and the chairman of the company making the test.
The story quotes the company’s website: a “trip to a fertility clinic for a semen analysis is not for everyone. These tests can be expensive (costing hundreds of dollars and not typically covered by insurance), inconvenient and are often embarrassing.” As we noted earlier, this test is not a replacement for the standard test that would be performed if the man visited the physician. Sperm count alone does not tell the complete story.
Why not interview an independent fertility specialist about the alternatives?
The entire story is based on the pending “debut” of the test.
The FDA approved the SpermCheck diagnostic test under a 510K approval process and decided it was the substantially equivalent to three previously approved products. While it may be the only product commercially available, it is certainly not the first to have received approval.
Some lines in the story are suspiciously similar to those in the company’s news release (see “Benefits” criterion above).
One quote is lifted directly from the news release – the company chairman quote: ”
“This at-home test was created to meet the needs of couples who are considering and just planning on starting a family, those currently having trouble conceiving and even those men who are just curious about their sperm count.”