In vitro diagnostics company Immucor this week said it plans to obtain a CE-IVD mark for its array-based, semi-automated, pre-transfusion blood analyzer in the current quarter.
Immucor is also developing a next-generation version of the system, which it plans to launch next year, according to CEO Gioacchino De Chirico.
The Norcross, Ga.-based company said it plans to make a new, fully automated version of the molecular immunohematology system available for research use only in the first half of 2011.
De Chirico said the company is "making progress" on this strategy. "The development of our next-generation automated instrument for the molecular business is progressing well, and during the fourth fiscal quarter, we expect to receive CE Mark approval for our current product offering," De Chirico said during a call to discuss the company’s fiscal third quarter, which ended Feb. 28.
A CE Mark will enable Immucor "to further commercialize our molecular product using our current semiautomated instrument in Europe," De Chirico added.
In 2008, Immucor paid $117 million in cash to acquire Warren, NJ-based BioArray Solutions (BAN 3/18/2008). The firm's technology provides 4,000-feature arrays in automated 8- and 96-chip formats.
In 2005, BioArray Solutions received 510(k) clearance from the US Food and Drug Administration to sell its extractable nuclear-antigens immunoassay. The test profiles six antibodies associated with autoimmune diseases and connective tissue disorders, including systemic lupus erythematosus, mixed connective tissue disease, Sjögren's syndrome, scleroderma, and myotisis.
BioArray Solutions, which now operates as an Immucor subsidiary, has also developed an array-based assay for human erythrocyte antigen screening, 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. A product is also in development for Rh factor variance screening for preventing Rh disease in newborns.
Immucor has seen an increase in array sales since acquiring BioArray Solutions. The firm's molecular immunohematology revenue, which is derived from sales of the BioArray platform, was $1.6 million in the third quarter of fiscal 2010 compared with $0.9 million in the prior-year quarter. These figures were dwarfed by Immucor's total Q3 2010 take of $80 million, up 7 percent from $75 million in Q3 2009, but still represented a 77 percent spike in sales, "primarily due to the introduction of our molecular offering to markets outside the US," De Chirico said.
Immucor sells direct in the US, Canada, Japan, Spain, Portugal, France, Germany, Italy, Belgium, the Netherlands, Luxembourg, and the UK. The company also maintains a network of distributors that serve most other markets.
De Chirico clarified in the call that the BioArray system is already available in Europe for research purposes, but the expected CE-IVD mark will allow more users in blood banks, clinical laboratories, and blood donor centers to adopt the technology.
According to Immucor spokesperson Michele Howard, the company's current BioArray offering automates the "back end of the process for reading and interpreting results," while the next-generation instrument will "automate the entire process." She told BioArray News in an e-mail this week that once the new system is launched in 2011, Immucor will seek a CE-IVD mark and FDA clearance for it. She did not provide a timeline for when the company hopes to have the system cleared in the EU or the US.
Immucor has been positioning the BioArray system as a next-generation technology to eventually succeed its current technology platforms. "In many countries, blood pre-transfusion testing is limited to the prevention of transfusion reactions and not for the prevention of alloimmunization, which occurs when antigens foreign to the patient are inadvertently introduced into the patient’s blood system through transfusions," the firm stated last week in a filing with the US Securities and Exchanges Commission. "By using multiplex, cost-effective molecular testing, our technology allows for testing to prevent alloimmunization for better patient care."
The company also hopes that BioArray Solutions’ array technology will put it ahead of rivals in the blood-testing market, such as Ortho-Clinical Diagnostics, a Johnson & Johnson company that targets the high-throughput blood-screening market with a microplate-based system called Vitros. The firm also offers a blood-grouping and Rh typing assay that uses gels and pipettes as well as other assays that compete against Immucor's current systems.
The first of these was the Galileo, launched in 2002, which relies on the firm's solid-phase, microplate-based technology for automated antibody screening and identification in 224 samples at the same time. In 2007, Immucor launched a lower-throughput version of the Galileo, called Galileo Echo, which can test 20 samples simultaneously. The system was cleared by the FDA in July 2007.
In February, Immucor launched the high-volume Galileo Neo, and has so far obtained a CE-IVD mark in the EU and regulatory approval from the Japanese Ministry of Health, Labor and Welfare. According to De Chirico, the Neo was submitted to the FDA in January and is awaiting clearance. Production of the initial Galileo system has stopped as Immucor rolls out the Neo, he said. He added that "Europe is a very important market for the Neo" as "more than 60 percent of the orders for Galileo were in markets outside the US with the overwhelming majority of these orders in the European market."
Because of Immucor's success in Europe, De Chirico said at that time of the BioArray Solutions acquisition in 2008 that the array technology will likely follow a similar route of market adoption. "The US is very resistant to change. If you look at the track record of all new technology, Europe gets it first, the US gets it last," De Chirico said. "So in Europe, for instance, we believe that they will be very receptive to this technology" (BAN 3/18/2008).