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TINY TICK, BIG THREAT: Dutchess leads state in babesiosis, another threat, besides Lyme disease, if you’re bitten by a deer tick

Illness can be passed through blood, but no test screens for it

7:22 PM, Dec 23, 2012

Babesiosis, a tick-borne disease that is growing more common, can be passed through blood transfusion from donors who do not know they are infected. This unit of donated red blood cells was seen at a blood bank in 2008. / Darryl Bautista/Poughkeepsie Journal

One was a 44-day-old baby with malformed lungs, another an 11-year-old boy on chemotherapy for a brain tumor. A third was a heart transplant recipient, 54, and three more were premature infants.

All received blood tainted with a rapidly spreading tick-borne parasite that infected four times as many New Yorkers last year as in 2002. The state ranked first nationwide in 2011 for the malaria-like malady, called babesiosis, and Dutchess County ranked first in the state, according to state and federal data obtained by the Poughkeepsie Journal. As the number of cases rises, babesiosis is poised to become a tick-borne scourge akin to Lyme disease, but with an especially vicious twist. The sometimes-fatal disease can pass from blood donors who do not know they are infected into a blood supply that has no test to screen for it. That’s why transfusion-transmitted babesiosis tripled from 26 cases nationwide in the first half of the 2000s to 83 in the latter half, according to a 2011 study in the Annals of Internal Medicine, a medical journal. There were 60 cases in New York since 1979 — with nearly half, 28, from 2005 to 2011. Of the six transfusion cases above, reported by physicians at two New York City hospitals, the heart recipient and two of the babies became ill, according to medical articles. They recovered, usually with treatment involving antibiotics and anti-malarial drugs. But at least 26 people have died since 1979 after receiving blood tainted with the Babesia pathogen — 10 since 2007, federal research shows. They include a 43-year-old woman with hepatitis C; a woman, 47, with diabetes and kidney disease; and a 76-year-old man with leukemia. Indeed, the elderly and sick are most vulnerable to babesiosis — and most likely to need transfused blood. Babesiosis is caused by a parasite, usually Babesia microti but other Babesia strains as well, that invades red blood cells; symptoms include fever, drenching sweats, muscle pain and anemia that may lead to internal bleeding and organ failure, according to the U.S. Centers for Disease Control and Prevention. The first national figures show 1,124 cases in 2011 from 17 reporting states. Nearly half of cases for which information was available resulted in hospitalization, while 6 percent to 9 percent of patients hospitalized for babesiosis died, according to one small study from the Lower Hudson Valley and two others from Long Island. “The situation with rising risk and incidence of babesiosis is alarming,” said Richard Ostfeld, a senior scientist at Cary Institute for Ecosystem Studies in Millbrook who this month reported nearly 1 in 5 ticks infected with Babesia on lands near the institute. That’s likely the highest reported rate in nymphal, or juvenile, black-legged ticks, the most dangerous stage when barely visible to the people they bite.

Little progress

Though the first transfusion-transmitted babesiosis case was reported in Boston in 1979, little has been done to protect the blood supply except to preclude donors who are known to have had babesiosis, according to interviews and a review of scientific literature. But with only 123 out of 23 million donors reporting having babesiosis from 2005 to 2007, that measure has been “largely ineffective,” said David Leiby, top researcher on the disease for the American Red Cross. A case in point is the six New York transfusion cases, involving two donors — from Suffolk and Westchester counties — who had not been sick with an infection that may not emerge for years, if at all. Just why tainted blood is slipping through the system relates to the high cost of developing a test that will have limited use and, therefore, limited earning potential for test manufacturers, scientists say. The test would be used primarily in just seven states — five in the Northeast and two in the upper Midwest — where the disease is considered native, or endemic. That’s a new challenge for a blood supply that operates on a national level, testing all blood for HIV, hepatitis B and C and West Nile virus. “The return on investment is not sufficient,” said Michael Busch, director of Blood Systems Research Institute, a San Francisco-based blood-safety research center. “That’s kind of created a lack of willingness.” Though at least three possible tests are in various stages of development, there was no indication when one might wend its way through the U.S. Food and Drug Administration licensing process, and the FDA said it could not comment on any trials. In the meantime, blood-supply officials sought to reassure the public on blood-supply reliability.
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ABOUT THIS SERIES

This is part 7 in a Poughkeepsie Journal series on the prevalence and problems of Lyme disease, the nation’s most common vector-borne disease. Go to www.pough- keepsiej- ournal.com/ lyme to read previous installments, view videos and read reports on Lyme disease and babesiosis.

— Will Carry Out Clinical Trials with Blood Systems Research Institute, Creative Testing Solutions —

BOSTON, MA — September 10, 2012 — Immunetics, Inc., has received a $3.7 million, two year SBIR contract from the National Heart, Lung and Blood Institute, an agency of the National Institutes of Health (NIH), to support clinical trials of a new blood screening test for Babesia infection.

“Babesia is among the top infectious threats to blood safety and, at present, there is no licensed test available. The NIH contract will allow us to address this gap in blood safety with the first cost-effective test designed for high-throughput screening of the blood supply.  We are honored to have been entrusted by NIH to carry out this public health mission,” said Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director.

Babesia is a parasite which is transmitted by the same ticks that transmit Lyme disease. While it is often asymptomatic in healthy people, Babesia infection can lead to severe or fatal illness, especially in immunocompromised patients. The parasites can remain viable in blood donations and infect transfusion recipients. In recent years, nine fatal cases of transfusion-transmitted babesiosis have been reported. Surveillance carried out by the Centers for Disease Control and Prevention (CDC) revealed over 1,000 cases of infection nationwide in 2011 — a number that appears to be growing. The US Food & Drug Administration (FDA) sponsored a workshop in 2008 focused on Babesiosis as an emerging threat to the blood supply, and the Blood Products Advisory Committee convened a meeting in 2010 to advise the FDA on approaches to blood screening for Babesia.

The contract award will enable Immunetics to bring its Babesia test, developed under initial NIH support, through clinical trials and regulatory licensure. The trials will be carried out in collaboration with Blood Systems Research Institute of San Francisco, Calif., and Creative Testing Solutions of Tempe, Ariz. Creative Testing Solutions currently tests about 25% of the US blood supply, including regions endemic for the parasitic agent. The Babesia test will initially be made available through Creative Testing Solutions’ laboratories.

“We look forward to partnering with Immunetics and BSRI in the development and FDA approval process of a Babesia assay for use in blood screening,” said Creative Testing Solutions President Sally Caglioti. “It is always our intent to offer innovative services that provide our customers with the best donor testing possible. Active collaboration in the development of diagnostic tests that fit the immediate needs of the blood banking community is the next logical step to support CTS’ mission.”

“When the screening test identifies antibody-reactive donors, we will enroll and conduct rigorous testing of donation-derived and follow-up samples from those donors so that we can more fully understand the natural history of Babesia infection in asymptomatic donors,” said Michael P. Busch, M.D., Ph.D., Blood Systems Research Institute Director and Senior Vice President for Research and Scientific Affairs at Blood Systems. “The information that we derive will help guide the development of policies on how the test can be used most effectively. It will also determine whether and how donors who have had a positive result on the screening test could safely donate in the future.”

For more information, visit the company’s website at http://www.immunetics.com or call 1-617-896-9100 or toll-free 1-800-227-4765.

Immunetics is a leading developer and provider of innovative tests for a variety of bacterial, viral, and parasitic diseases. Recently, the company received FDA clearance for its BacTx® test for bacterial contamination in platelets. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for HIV and Chagas disease — both of which are known or emerging risks to the blood supply.

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http://www.immunetics.com/pr_120910.html