First blood treatment system in US could cut cost of transfusions
It is difficult to say how much of a role panic over this summer’s Ebola outbreak played in the FDA’s decision to approve Cerus’s blood filtration system, but it seems likely to have contributed. The agency last month rushed through a trial expansion as a back-door way of permitting use of the Intercept device to treat Ebola survivors’ plasma as a treatment for the virus.
Intercept has now been granted full premarket approval for reduction of the risk of transfusion-transmitted infections. The company’s 23% share price spike to $5.86 yesterday may also be partly due to investors betting that Ebola will continue to drive demand, but Intercept will have to go much further than addressing seasonal flare-ups to justify this jump in valuation.
Intercept is now approved to destroy viruses including HIV, hepatitis B and C and West Nile virus, as well as a range of Gram-positive and Gram-negative bacteria, spirochetes and parasites in donated blood. The device uses a photochemical treatment to crosslink the nucleic acids present in the plasma, rendering the microbes incapable of replicating and causing disease. It is the first plasma pathogen reduction system to be approved in the US.
It has been on sale in Europe for more than 10 years, where it may be used to treat both plasma and platelets.
The PMA is an important milestone for Cerus as it officially permits the sale of the product to US customers – laboratories and hospitals – and for a wider range of pathogens. However, many units were already in use in the US as part of the company’s investigational device exemption (IDE) studies.
In mid-November the FDA permitted the system’s use at Emory University Hospital to treat Ebola survivors’ plasma and to produce stockpiles of treated plasma for future outbreaks. Antibodies to the Ebola virus would remain in the plasma and it is thought that this might aid patients to fight the infection.
Previously, in July, a similar arrangement was made for use of the system to kill the chikungunya and dengue viruses, but in donated platelets rather than plasma.
The system is not perfect. The FDA cautions that while Intercept has been shown to reduce many viral and bacterial pathogens, it does not eliminate them all. Certain viruses, such as human parvovirus B19, and spores formed by certain bacteria are known to be resistant to the Intercept process.
Cerus points out that in an era of increased travelling and immigration, donated blood may carry pathogens for which no screening tests are available. Intercept’s broad-brush approach means they can be destroyed without even needing to be identified.
Theoretically this could lead to more donated plasma being useable, although it is hard to imagine blood from, for instance, HIV-positive donors being used for transfusions even after treatment with Intercept.
The best case scenario for Cerus is that Intercept becomes an integral part of the blood transfusion process in the US, used routinely to treat donated plasma – and, pending approval, platelets. Premarket approved for platelet treatment is expected early next year.
In a note in September, analysts from Cowen wrote that Intercept “will eventually become the gold standard for blood transfusion safety worldwide”.
Economic data could help Cerus’s sales efforts. According to Wedbush analysts, a study by five institutions including Stanford University and Harvard University suggested that the potential cost savings from using Intercept came to $187 per unit of platelets. The savings came from eliminating tests for microbes such as West Nile virus, syphilis and the protozoan Trypanosoma cruzi, as well as the resulting extra shelf life.
The study said that of the total savings, roughly $100 could accrue to the blood centres and $87 to hospitals; if this is true it will be music to payers’ ears.