Agilent Technologies continues to engage the US Food and Drug Administration about the optimal path forward for its microarrays that are used in constitutional and cancer cytogenetics, a company executive said this week.
In the meantime, Agilent continues to build resources to gain FDA clearance for arrays and other products.
"We just getting our toe in the water," Nick Roelofs, president of Agilent's Life Sciences Group, said during a conference call held this week to recap the company's fiscal first-quarter financial results, which included an 8 percent uptick in total revenue and a 14 percent spike in Life Sciences Group revenues. "We do not yet have a big push here, we do not yet have a big, significant presence in regulatory or clinical trial management, so these are elements that we'll need to work through."
To that end, the company "continue[s] to work with the FDA to understand the best route" for submitting its cytogenetics-focused arrays for clearance, Roelofs told BioArray News in a follow-up interview.
Agilent has been discussing the regulatory status of its cytogenetics-focused arrays with the FDA for at least two and a half years (BAN 10/13/2009 ). The firm markets its chips for research use, though laboratories that offer clinical cytogenetic testing use Agilent-made arrays, as well as chips manufactured by other vendors, in their services, considering them components of laboratory-developed tests.
Most big array vendors have acknowledged plans to have their platforms cleared for clinical use. Affymetrix has promised to submit its CytoScan array to the FDA for clearance by the middle of this year and Illumina has discussed a similar plan (BAN 1/17/2012 ). Roche NimbleGen has also said that it is discussing a path forward to gain clearance for its arrays.
Agilent's ability to obtain clearance for its platform has ramifications for other labs and companies. Agilent makes custom arrays for firms like Oxford Gene Technology, CombiMatrix Molecular Diagnostics, and BlueGnome.
Roelofs declined to discuss the status of specific product trials or timelines.
In addition to building its diagnostics resources, Roelofs discussed "gaps" in the firm's path to the clinic, such as "how do we get to the customers and how do we educate the doctors," as well as issues concerning reimbursement.
Roelofs clarified in a follow-up interview that the comment was focused on all Agilent technologies that might go into diagnostic applications in the future, including microarrays.
Agilent said last week that its total revenues for the three months ended Jan. 31 were $1.64 billion, compared to $1.52 billion a year ago. Life Sciences revenues climbed to $461 million from $404 million.
Among the Santa Clara, Calif.-based firm's other segments, Chemical Analysis revenues increased 13 percent to $396 million from $349 million and Electronic Measurement revenues ticked up a fraction of 1 percent to $778 million from $771 million.
In FY Q1 Agilent increased its R&D spending 2 percent to $162 million from $159 million in the year-ago period. Its SG&A costs contracted 1 percent to $441 million from $446 million.
The company saw a profit of $230 million compared to $193 million a year ago.
Agilent finished the quarter with $3.66 billion in cash and cash equivalents.
The company said that for the fiscal second quarter revenues are anticipated to be in a range between $1.70 billion and $1.72 billion.
For full-year 2012, the company said revenues are now expected in the range of between $6.92 billion and $7.02 billion.
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