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In Sentilus Acquisition, Immucor Sees 'Inherent Value' of Microarrays for In Vitro Diagnostics

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NEW YORK (GenomeWeb) – Immucor last week announced its acquisition of Sentilus, an early stage company developing microarray-based applications for clinical use, including transfusion diagnostics.

For Norcross, Ga.-based Immucor, a leading provider of serology platforms, Sentilus is the second microarray company acquired by the firm to date. In 2008, Immucor paid $117 million to buy Warren, NJ-based BioArray Solutions, whose BeadChip platform became the foundation for Immucor's PreciseType Human Erythrocyte Antigen test, which clearance earlier this year.

Michele Howard, an Immucor spokesperson, told BioArray News in an email this week that the company is looking forward to expanding its microarray-based product range with the Sentilus acquisition and believes there is "inherent value in applying microarray-based technologies" to in vitro diagnostics.

"Within the immunohematology market we serve today, we believe microarrays help unlock important information about patients and donors, thus enabling better transfusion medicine," said Howard. She said that the FDA's clearance of PreciseType HEA demonstrates the ability of microarray technology to produce "high-quality, information-rich data," noting such characteristics are "highly valued" by Immucor's customers.

Durham, NC-based Sentilus was founded in 2012 by Ashutosh Chilkoti, professor of biomedical engineering at Duke University, and Angus Hucknall, a graduate student in Chilkoti's group. The company's primary focus is a non-fouling polymer brush technology for the detection of protein analytes. According to Chilkoti's webpage, the polymer coating eliminates the largest source of assay noise — non-specific binding — maximizing signal to noise in heterogeneous immunoassays.

This enables clinicians to detect proteins at levels previously too small to observe by standard immunoassays from blood, serum, urine, or saliva, according to Chilkoti. The company has also used the technology to develop a microarray technology, called Femtoarrays, that quantitatively measures multiple analytes from a drop of blood. On his Duke University webpage, Chilkoti claims that the technology is also useful for isolating rare cell types; coating implants and biomedical devices; and developing tools and reagents such as magnetic capture beads, affinity chromatography media, and filters.

"We are impressed with many aspects of the Sentilus technology, including its flexibility and the potential for a broad range of applications throughout IVD," Howard said. "Our near-term plans are for the technology to serve as the basis for our next-generation serology transfusion products."

She noted that Sentilus is a pre-commercialization company and that all activities related to the Sentilus technology will take place in Immucor's Norcross facilities.

Though Immucor is touting Sentilus' Femtoarrays as the foundation for its next-generation products, it sees the technology as "complementary" to PreciseType HEA, rather than a replacement, Howard said.

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, according to the firm. 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.

The test is based on BioArray Solutions' BeadChip platform, a custom bead array technology that combines bead chemistry with semiconductor technology to enable quantitative multiplexed DNA and protein analysis.

Immucor has positioned its 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. 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.

Though Immucor gained a CE/IVD mark for PreciseType in 2010, it took another four years to gain FDA approval for the test. In addition to PreciseType and now Sentilus, the three-decades-old company also offers its automated Galileo Echo and Neo instruments, which rely on the firm's solid-phase, microplate-based technology for automated antibody screening and identification.

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