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With FDA Approval in Hand, Immucor Sets out to Convert Blood Transfusion Labs to HEA Array Test

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NEW YORK (GenomeWeb) — Immucor believes the recent US regulatory approval of its microarray-based PreciseType Human Erythrocyte Antigen test for determining blood compatibility will encourage more customers to introduce the assay in a clinical setting.

Joel de Jesus, senior director of marketing for Immucor's molecular business, told BioArray News that the US Food and Drug Administration's pre-market approval of PreciseType HEA will allow existing customers that use the research-use-only version of the test to offer it as an in vitro diagnostic. It may also entice blood transfusion laboratories that use conventional serological techniques — to date the only assays available in the US with IVD status — to move to Immucor's array platform .

"Immucor expects to expand the market of molecular red cell antigen testing [and] it's educating potential users in a hands-on way," said de Jesus of the company's activities since gaining the approval. "People see the benefit of an IVD product: they can provide molecularly matched blood to patients while minimizing the regulatory and accreditation risk associated with RUO test use," he added.

Immucor's PreciseType HEA can identify 35 red blood cell antigens from 11 blood groups simultaneously, enabling the complete blood typing of patients and donors, and allowing increased transfusion compatibility. By using the test, labs can reduce the risk of alloimmunization in patients, where the blood recipient's immune system develops antibodies that can attack and reject the donor red blood cells. The PreciseType test also allows users to identify donors with rare or unusual antigens so blood banks can distinguish and save scarce units for special cases.

Immucor has sought FDA approval for the test for years. The three-decade-old, Norcross, Ga.-based company created a leadership position for itself through the launches of its automated Galileo Echo and Neo instruments, which rely on the firm's solid-phase, microplate-based technology for automated antibody screening and identification. It bet on microarrays when it acquired BioArray Solutions for $117 million in 2008, touting the Warren, NJ-based firm's BeadChip platform as its next-generation technology. Immucor obtained a CE-IVD mark for PreciseType HEA in 2010, and subsequently rolled out the product for research use in the US, but it has taken additional years to see it through the FDA's PMA process.

Immucor is now positioning the assay as the "test of record" for molecular blood group typing, meaning that the assay can be used for clinical decision-making purposes by itself, without having to confirm with a second method, as users of its research-use platform had to do in the past. Along with having the same regulatory status as conventional serological methods, de Jesus maintained that his firm's assay has some inherent technological advantages.

"Until now, serology methods have been considered the gold standard, and the only method with IVD status," said de Jesus. "But there are holes. For some antigens the antisera is very rare, and in some case no IVD ones exist," he said. "Immucor and [doctors] who work every day with chronically transfused patients would like nothing better than to see the standard of care change so that molecular matching of patients and donor blood is the rule, rather than the exception as it is today," he added.

Convincing labs to move from long-employed approaches to newer, higher-throughput and multiplex platforms seems to be an industry-wide phenomenon. From cytogenetics, where array companies like Affymetrix, Agilent Technologies, and Illumina advocate the use of chromosomal microarray analysis over conventional karyotyping; to infectious disease testing, where companies like Luminex, Nanosphere, GenMark Diagnostics, and others are looking to penetrate labs that still rely on culture, firms that sell multiplex molecular diagnostics must educate and persuade cautious clinicians of the greater value of their more complex tests, which often have higher upfront costs.

Immucor's de Jesus said that his company has done its "utmost to lower barriers to adoption" of its system, opting for a less expensive microscope-based reader rather than selecting pricier reading technologies, as one example. He also noted that the firm has worked through the American Medical Association's pathology caucus to obtain a current procedural technology code for the test, which should become active as of July 1.

De Jesus also argued that testing on the PreciseType HEA platform is likely to be less expensive that conventional techniques, citing a study of costs associated with serologic testing published in the journal Transfusion last year. "When you look at the cost of complex serological workups ... molecular testing is more cost efficient for finding matched blood for patients who require frequent red cell transfusions," de Jesus said.

According to de Jesus, Immucor has several RUO customers who have been waiting to introduce clinical testing on the platform. In a statement, the company named three institutions that have used the test: Children's Healthcare of Atlanta, the American Red Cross, and the New York Blood Center — NYBC helped generate some of the data that was used in Immucor's PMA submission. These RUO customers can now upgrade to the clinical version of the test, de Jesus said, noting that the firm is "scheduling conversions of its current customer by providing updated instrumentation and new software that has been cleared by the FDA."

De Jesus said that Immucor's Galileo Echo and Neo customers will also find it easy to adopt the FDA-approved test, though the firm does not expect its clients to choose one over the other. "The molecular platform co-exists nicely in labs with the Echo and Neo platforms," he said. "They remain appropriate for simple screens versus complex workups and probably will for some time."

The company may also pursue FDA approval for the remainder of its array-based tests, such as its CE-IVD-marked Human Platelet Antigen assay for use in platelet genotyping. CEO William Hawkins said in a statement that Immucor is "committed to taking our full menu of molecular assays through the FDA process to ensure widespread access and help improve patient outcomes for transfusion patients everywhere."

De Jesus acknowledged that Immucor has other BeadChip tests available for research use, including tests for the RhD and RhCE genes. All of the tests run on the same platform as PreciseType HEA, he noted. He did not elaborate.

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