Denise Roland reports in the Wall Street Journal:
The blood of recovered Covid-19 patients is essential to developing, and selling, an antibody test. Diagnostic companies say high prices for the blood of recovered patients are posing a hurdle to developing tests. One broker quoted $1,000 for a one-milliliter sample of the antibody-containing part of the blood from recovered patients. Diagnostics companies need a few dozen samples to meet approval requirements. Blood demand is outstripping supply.
The blood business is booming.This normally obscure trade has been set alight by the race to develop Covid-19 antibody tests, which use blood to tell whether someone has already been infected with the coronavirus. The tests are seen as key to easing lockdowns that have shut down economies around the world.However, while surging demand has proven a boon for the traders known as blood brokers who source this commodity, diagnostic companies say high prices for the blood of recovered Covid-19 patients are posing a hurdle to developing tests.“We’ve had a terrible time trying to obtain positive specimens at a decent rate,” said Stefanie Lenart-Dallezotte, manager of business operations for San Diego-based Epitope Diagnostics Inc., which sells an antibody test for Covid-19. “I feel people are taking extreme advantage of the situation because they can, because there’s crazy demand.”She said one broker quoted $1,000 for a one-milliliter sample of convalescent plasma, a term for the antibody-containing part of the blood from recovered patients.Executives at other diagnostics companies say they have been quoted prices of several thousand dollars for one milliliter of plasma.Diagnostics companies need at least a few dozen of these samples to meet emergency approval requirements, though some want hundreds to better ensure the performance of their tests.“Disease-state” blood for most conditions typically ranges from a few dollars to a few hundred dollars per sample—usually around a milliliter—depending on the rarity of the disease and the logistics involved in sourcing it.Blood that contained antibodies for a tropical disease only found in a remote part of the world, for example, would cost much more than blood for common diseases like hepatitis C. Prices normally reach four figures per milliliter for only extremely rare conditions, according to diagnostics companies and brokers.The blood of recovered Covid-19 patients is essential to developing, and selling, an antibody test. It has become an especially hot commodity since the Food and Drug Administration cracked down on dozens of inaccurate tests that flooded the U.S. market after the virus spread globally and started requiring that any new tests undergo review by the agency before going on sale.The only way to determine the accuracy of a test is to run it against samples known to contain antibodies to Covid-19, and ones known to lack them. The FDA now requires diagnostics companies to run their tests against at least 30 positive samples and 75 negative samples to obtain emergency approval for Covid-19 antibody tests.Diagnostics companies also need to include a vial of convalescent plasma when they sell their tests to laboratories. That is so the laboratories have a “positive control” to run alongside each batch of tests they perform for customers. If the positive control returns a negative result, it shows that there was a fault either with the chemical ingredients used in that batch, or in the way the test was conducted. If that happens, all the tests in that batch need to be rerun.Blood that recovered patients donate to hospitals and nonprofit blood banks like the American Red Cross is generally reserved for use as an experimental treatment for patients with severe Covid-19, leaving the diagnostics industry looking elsewhere.That is where blood brokers come in. Some run donation centers where they pay donors for plasma. Others buy up what is known as remnant blood, the leftovers from blood tests run in laboratories that would otherwise be consigned to the clinical waste bin. Laboratories tend to charge a flat rate for remnant blood regardless of its rarity, as the main benefit for them is to save on disposal costs. Sometimes the agreements don’t involve cash at all, but a barter of laboratory supplies, according to brokers and clinical laboratory executives.German supplier Biomex GmbH said blood demand from its established customers is outstripping supply.The company collects and processes convalescent Covid-19 plasma directly from recovered patients who visit its donation centers in Heidelberg and Munich. Donors receive around €250 ($271) per draw, which usually yields 650-850 milliliters of plasma. The company declined to disclose exactly what it sells at, saying it charged just a few euros per milliliter.“We don’t increase prices because of short supply,” said Oliver Bosnjak, Biomex’s general manager. “I try to be a reliable partner and serve the market, and get my bills paid.” He said that plasma collected at the donor centers and sold in bulk was generally cheaper than remnant plasma samples because it was easier to obtain at high volumes.Florida-based Boca Biolistics LLC has also seen strong demand for blood samples of Covid-19 patients. “We’re getting inquiries from around the world, whether in Asia, Europe or here in the U.S.,” said Chief Development Officer Valentin A. Adia Jr. The company is preparing to sell a product comprising 10 samples of convalescent plasma and 10 negative samples, sourced from laboratory remnants, at a price of around $500, he said.Boca has also set up a program to collect multiple samples from Covid patients at different stages in their disease, to better understand how the concentration of antibodies in the blood changes over time.Still, despite brisk trade, blood brokers face challenges. For instance, Biomex said supply is drying up as the number of cases in Germany falls. Another issue: Only around a third of donations have high enough concentrations of antibodies to be used as a positive control for antibody tests.Frustrated at the difficulty of getting affordable convalescent plasma, some diagnostic companies are trying to cut out the middleman.Framingham, Mass.-based Kephera Diagnostics LLC, which began work on an antibody test in March, started appealing directly to recovered coronavirus patients for free donations of a few drops of blood taken from a finger prick.“There was a land grab going on,” said Andrew Levin, Kephera’s president and scientific director. “It became a fairly high value commodity.”Mr. Levin said brokers quoted him $1,000 per sample earlier in the pandemic, although prices have come down to $100-$300 in recent weeks. He said Kephera is now using a mix of the donated finger-prick blood and plasma from suppliers to develop its test.
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