The US Food and Drug Administration last week granted 510(k) approval to BioArray Solutions' extractable nuclear antigens (ENA) immunoassay BeadChip Test System, which runs on the company's Array Imaging System, making it the second microarray-based assay to clear the federal regulatory body in the last six months.
The approved assay profiles six antibodies associated with autoimmune diseases and connective tissue disorders, including systemic lupus erythematoseus, mixed connective tissue disease, Sjögren's syndrome, scleroderma, and myotisis, the company said on its web site.
Michael Seul, the president of the Warren, NJ-based company, said in a statement that the clearance represented "an important milestone for BioArray Solutions" and that it attested "to the viability of [its] array format in the clinical setting."
The ENA assay, according to BioArray Solutions, is a customizable bead chip that allows researchers to "simultaneously detect multiple analytes of interest on a silicon chip holding a planar array of color-encoded microparticles."
Donna DeLong, a spokesperson for the company, told Pharmacogenomics Reporter's sister publication BioArray News this week that BioArray Solutions expects to file applications with the FDA for other assays that run on the company's AIS 400 imaging system. The company also is commercializing several research-use-only and analyte-specific-reagent assays, DeLong said.
"We haven't filed for any of the other assays yet. We just finished one, so now we are working on another one," DeLong said.
DeLong said that the company's strategy is to place its systems in labs for use by clinicians that are working in the molecular diagnostics space. "The target consumers are clinical laboratories," she said. DeLong said that, so far, the company has several academic and non-profit labs that are beta-testing the system.
"We retain title to the instrument. It's placed on a reagent-rental basis. As long as there's a certain commitment of purchase per year, then the instrument is placed at no charge," DeLong explained.
Current users of the system and its accompanying assays include researchers at the University of Southern California in Los Angeles, and at the New York Blood Center.
"We do have systems out in the field. They are on evaluation right now," DeLong said.
The company's travel itinerary also reflects its target customer base. For example, penciled in for the company's fall and winter schedule are stops at a meeting of the American Association of Blood Banks in Seattle in October and a meeting of the American Society of Hematology in New Orleans in December.
DeLong could not provide an estimate of the market for BioArray Solutions' assays and imaging system, but said "the total market for molecular diagnostics is approximately $1.6 billion and is growing at 20 [percent] per year."
DeLong said that while the system itself is free for users, pricing for the assays varies, depending on the product and the volume of tests at the customer site.
One assay the company may pursue FDA clearance for is its human erythrocyte antigen (HEA) BeadChip Test, which provides 18 biomarkers on a substrate to screen for blood group antigens in the Duffy, Kell, Kidd, Lutheran, MNS, Dombrock and other blood group systems as well as a mutation associated with sickle cell disease.
In a partnership with the New York Blood Center's Immunohematology Lab, BioArray Solutions compared the results of its platform with those generated by traditional blood screening methods such as serological hemagglutination. In a May press release, the company described the latter method as "labor intensive and expensive" compared to its HEA BeadChip Test, which it claims can supply a red cell antigen genotype in less than five hours.
The results of the study were published in the May issue of Transfusion, the journal of the American Association of Blood Banks. Marion Reid, the director of the Immunohematology Lab at the New York Blood Center, said in a statement that BioArray Solutions' technology "has the potential to increase the inventory of specific antigen negative blood and permit the creation of diverse inventories of genetically characterized blood units available for delivery."
Reid and her co-authors wrote in Transfusion that the collaborators "have shown the feasibility of use of the random encoded microparticle array format to enable comprehensive DNA typing of donors."
Reid added that the system was "especially useful for chronically transfused patients" and could "reduce and ideally prevent the incidence of alloimmunization to blood group antigens."
BioArray Solutions did not comment on which assay it will seek FDA clearance for next.
Justin Petrone ([email protected])
This article originally appeared in BioArray News, a Pharmacogenomics Reporter sister publications.