Arrayit said this week that it has appointed Docro to help with its plans to get regulatory approval of its OvaDx ovarian cancer diagnostic in the US.
The company did not specify what role Docro would have, but said in a statement that the Seymour, Conn.-based diagnostic oncology contract research organization has "steered" almost 100 in vitro diagnostic clinical trials through the US Food and Drug Administration in the past 12 years.
On its website, Docro also calls itself a "full service research organization specializing in the design and conduct of clinical trials of in vitro diagnostic products to gain marketing clearance or approval," from the FDA.
Docro has been able to get 39 pre-market approvals and 46 510(k) application approvals and has a 99 percent success rate with the FDA, according to Arrayit.
OvaDx is a protein-array based test comprising 100 proteomic biomarkers and detects both early- and late-stage ovarian cancer, Arrayit said.
The test uses a microarray-on-a-planar-surface format and is serum-based, and was developed using Arrayit's proprietary technology in which protein samples are loaded from 384-well microplates into 48 printing pins by capillary action. They are then deposited onto 210 glass substrates.
"Using absorptive interactions, the glass surface gently pulls [the] sample off the pin tips, resulting in printed protein microarrays that retain full biochemical activity," Array CEO Rene Schena told ProteoMonitor earlier this year [See PM 01/08/10].
The Sunnyvale, Calif.-based company said in December that it anticipated filing for a PMA "shortly" after the end of 2009. "Notwithstanding any unexpected delays with the 510(k) review and approval process, we are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010, followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010," Arrayit said.
Arrayit did not provide an update on an anticipated filing date.
Last summer, the company created a subsidiary, Arrayit Diagnostics, headquartered in Houston, to market and sell OvaDx.
Arrayit is one of several firms that plan to market a proteomics-based diagnostic for ovarian cancer or have done so [See PM 03/19/10].
Vermillion's OVA1 became the first protein-based in vitro diagnostic multivariate index assay to receive FDA clearance [See PM 09/17/09] and earlier this month it and Quest Diagnostics began marketing OVA1. In addition, Correlogic is in discussions with the FDA about its OvaCheck test, and Healthlinx, which launched its test called OvPlex in the UK in February, has said that it may launch the test in the US next year, if it receives regulatory approval.
This week, Arrayit said that OvaDx will be the market's first "comprehensive diagnostic for ovarian cancer" and will be targeted to all women over the age of 35.