The recent Wall Street Journal report by Christopher Weaver on Non-Invasive Prenatal Screening (NIPS) included a number that suggests how much money is in the NIPS market. But what else should that money be going towards?
The WSJ article reported that in 2012, Sequenom performed 61,000 of its MaterniT21 test, its brand of NIPS. In a previous post I shared a table that reported Sequenom was charging $2,762 per test. This means, if Sequenom received full payment for its tests, then it took in more than $168 million (61,000 tests X $2,762 = $168,482,000) in gross revenue in 2012.
The report on Sequenom’s 2012 test numbers corroborated an earlier estimate of the NIPS market. In January, it was announced that Illumina acquired Verinata, the maker of verifi, for $360 million. The story reported that the total NIPS market was estimated at over $600 million. But that figure does not include a cost recognized by test manufacturers and professional medical organizations as needed for administering NIPS ethically.
When Sequenom went to market, it was based on a study that supported the validity of its testing. In that same study, the authors cautioned that educational materials were needed for both providers and patients so that they understood the testing and the tested-for conditions. Similarly, at the 2012 International Society of Prenatal Diagnosis conference, Diana Bianchi, one of the lead developers of Verinata, emphasized that accurate information about the test and Down syndrome was needed to be provided to patients.
As of this date, however, neither company provides the Down syndrome prenatal resources recognized by the National Society for Genetics Counselors and the American College of Medical Genetics. These resources are available on-line at no cost and in print form for $11. And, the number for providing these resources is not 61,000, but a much smaller one.
As Weaver’s report notes, most women accepting prenatal testing are doing so not to actually find out if their child has Down syndrome. Rather, almost every woman interested in prenatal testing is doing so to find out that their child does not have Down syndrome. For inclusion and societal acceptance purposes, having every expectant mother receive accurate, medically-reviewed materials about Down syndrome may be a net positive. But, from a strictly medical perspective, for almost all of the millions of expectant mothers each year, Down syndrome will be irrelevant to their specific pregnancy because their child will not have the condition.
Therefore, the relevant audience to receive these medically-reviewed, accurate resources are the few thousand of mothers each year who are actually pregnant with a child that has Down syndrome. Providing the recognized resources by professional organizations amounts to a fraction of a fraction of the total revenue NIPS laboratories are making off of their tests.
To be fair, in the same report on Verinata’s acquisition, it also was shared how Verinata had invested over $100 million and 10 years in developing its test. These costs are likely the same for each NIPS laboratory. Therefore, even if Sequenom did take in all of its potential revenue from the 61,000 tests performed in 2012, that would still leave just over $60 million remaining once its development costs were accounted for. That $60 million is gross revenue and quickly puts the ledger books still in the red when the actual cost of administering the test is factored in.
So, the 61,000 figure suggests Sequenom made a lot of money in 2012, but that it likely was not enough to realize a profit and very likely still ended the year in the negative. The same likely is true for all NIPS companies where revenue coming in from their tests still has not exceeded the amount invested in developing the tests. But what price ethics?
Weaver’s report shares how NIPS now is being covered by major insurers. Therefore, the costs of the materials the test manufacturers and professional organizations recognize should accompany test results could be built into those costs.
The testing companies have been in dialogue about providing these resources. Some already provide links to these resources on their websites. Perhaps, these resources will be provided to patients by the testing companies with a positive result of their NIPS tests. And, hopefully soon.
Mark – was the recommendation to provide counseling prior to testing or after a positive result? I thought it was the former.
The professional statements all state that patients should be counseled on the limitations of the testing in pretest counseling, with patients then being referred to genetic counseling following a NIPS result.