Immucor plans to launch its automated array instrument for blood testing next year. The Norcross, Ga.-based in vitro diagnostics firm originally said the molecular immunohematology system would be available for research use during the first half of 2011.
Still, while the company has delayed the launch of the system, CEO Gioacchino De Chirico said the postponement will have no impact on the timing of Immucor's plan to eventually submit the same automated system to the US Food and Drug Administration for clearance.
De Chirico discussed the delay of the automated instrument during the firm's fiscal third-quarter earnings call earlier this month. "We are continuing the work on the automated instrument, although our research-use-only timing has changed," De Chirico said. "We now expect a research-use-only instrument to be available in calendar 2012," he said. "We do not see this change as a delay in the timing for our overall FDA approval process or our commercialization plan for our molecular offering."
Immucor paid $117 million to acquire Warren, NJ-based BioArray Solutions in 2008 and has since developed the firm's array platform with the hope that it will succeed its current generation of blood-testing instruments. Immucor's suite of instruments, called Galileo, rely on the firm's solid-phase, microplate-based technology for automated antibody screening and identification (BAN 3/18/2008).
The BioArray Solutions technology provides 4,000-feature arrays in automated 8- and 96-chip formats. The BioArray Soutions platform is semi-automated. While the array-based testing process itself is primarily manual, the current generation BioArray Solutions instrument does automate the reading and interpretation of test results.
After relaunching the semi-automated platform following the acquisition, Immucor in July 2010 achieved a CE-IVD mark for its Human Erythrocyte Antigen BeadChip for molecular immunohematology in vitro diagnostic purposes (BAN 7/20/2010). The firm has also obtained a CE-IVD mark for its Human Platelet Antigen assay for use in platelet genotyping, as well as its instrument, the Array Imaging System.
During the call, De Chirico said that the firm's array-based offering is "an important part of our future growth."
The firm has been developing a fully automated instrument upon which it hopes to both release as a research use system as well as a diagnostics platform. While the launch of the system for research use has been delayed, the firm's internal timeline for submitting the system with assays to the FDA for clearance has not.
De Chirico also said that the delay in launching the research use automated instrument, ahead of submitting it to the FDA, was tied into the instrument development process rather than any trouble with the assays run on it. He maintained that since it takes longer to get reagents cleared by the agency, the firm has time to finish development of the automated system before submitting the instrument for review.
"Basically, what we have to consider in the process here that there are two components of the system: one is the equipment, and one is the reagents," said De Chirico. The company is pursuing premarket approval for the assay reagents, which will "take longer" than the approval for the instrument, which will most likely follow the agency's 510(k) route, he said.
De Chirico hypothesized that by the time the reagents make their way through the PMA process the instrument will be ready for a quicker 510(k) submission.
"The development of the research-use-only instrument will not impact the overall timing because at the end of the day, you need to have both reagent and equipment FDA approved to go to market," he said. "The commercialization plan has not changed," he added.
While Immucor has now committed to having the research system in the hands of American customers sometime in 2012, it has not provided a timeline for when it hopes to achieve FDA clearance. De Chirico did predict that the operation will "become accretive one year after FDA approval."
Immucor hopes to sell the system to blood banks. "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 noted in an April 7 filing with the US Securities and Exchange Commission.
"If alloimmunization occurs, the patient develops new antibodies in response to the foreign antigens, thereby complicating future transfusions," Immucor said in the filing. "By using multiplex, cost-effective molecular testing, we believe that our molecular technology allows testing to prevent alloimmunization for better patient care."
Despite achieving a CE Mark for its array-based molecular immunohematology platform last year, sales of the platform and accompanying reagents were down during the third quarter of Immucor's fiscal 2011, which ended on Feb. 28.
Molecular immunohematology revenues fell 13 percent to $1.4 million during the quarter from $1.6 million in the prior-year period. At the same time, molecular immunohematology sales for the first nine months of FY 2011 rose 14 percent to $4.1 million from $3.6 million. The firm attributed the Q3 drop to "weaker US demand" during the quarter.
The results for the molecular immunohematology business were dwarfed by Immucor's total revenues. Receipts for Q3 FY '11 were $83 million, up 4 percent from $79 million in the prior year period.
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