The Affymetrix Clinical Services Laboratory and Connecticut-based contract research organization DOCRO have penned an alliance to help drug and diagnostic companies commercialize their in vitro diagnostic products by steering them through the US Food and Drug Administration’s regulatory process.
“The two companies will work together to help customers gain clearance or approval of IVD products from the US FDA and bring those products to market faster than before,” an Affymetrix spokesperson told Pharmacogenomics Reporter this week.
The ACSL is Affy’s 10,000-square-foot CLIA-certified reference lab in West Sacramento, Calif., which offers microarray-based molecular diagnostic patient testing and clinical trial testing services to pharmaceutical companies, diagnostic shops, and research laboratories developing personalized tests.
ACSL partnered with DOCRO noticing a deficit in the diagnostic industry. Despite advances in microarray technologies, the science has been slow to translate that knowledge into marketed diagnostics.
“Over the past decade, there have been hundreds of microarray discoveries – expression and genotyping – with potential diagnostic implications,” Affy said in a statement this week. “However, researchers have not had effective or efficient means to translate these discoveries into validated clinical diagnostic tests.”
Both Affy and DOCRO are experienced in navigating through FDA’s regulatory processes. Affy’s GeneChip 3000Dx System is the first microarray system to be cleared by the FDA for diagnostic testing. Roche’s FDA-cleared AmpliChip cytochrome P450 genotyping test is based on Affy’s GeneChip technology.
DOCRO, for its part, has more than 80 FDA submissions and over a decade of IVD industry experience under its belt. The company’s suite of services includes strategic consulting, product development, specimen acquisition, and regulatory consulting.
“Customers often do not have effective or efficient means to translate molecular signatures into validated clinical diagnostic tests,” the Affy spokesperson said. “To fill this unmet need, Affymetrix sought to find a co-marketing partner with clinical validation experience. DOCRO has clinical trials expertise, as well as extensive experience in preparation and submission of 510(k) and PMA filings.”
Under the agreement, DOCRO will help ACSL customers design study protocols, recruit patients, train and monitor clinical sites, procure clinical samples, predicate device testing, and provide guidance through the regulatory submission process.
One of the main goals for ACSL is to accelerate the introduction and adoption of new diagnostic tests in the market. Drug and diagnostics companies can also use its CLIA-certified laboratory as a clinical trials site, and to optimize and standardize its assay protocols.
“Over the past decade, there have been hundreds of microarray discoveries – expression and genotyping – with potential diagnostic implications. However, researchers have not had effective or efficient means to translate these discoveries into validated clinical diagnostic tests.”
By working with ACSL, Affy can help its customers offer the diagnostic first as a laboratory-developed test until it garners FDA clearance. Once a test receives FDA clearance, “ACSL can transfer the well-validated protocols and expertise through training programs to enable other labs to offer the test themselves.”
The Affy/DOCRO alliance resembles an effort Roche unveiled in 2003 that aims to assist pharma companies in creating diagnostic components to therapeutic candidates and reinvigorating ailing drugs by organizing clinical trials; analyzing clinical data; validating markers; and developing, manufacturing, and marketing IVD assays [see PGx Reporter 06-13-2003].
However, when Roche launched its in-house service, called SynergysDx, industry observers warned that pharmaceutical companies may be reluctant to use Roche’s diagnostics expertise, particularly if they are competing with the company in a particular disease area.
How Affy will manage similar concerns about its program is not immediately clear.
Under the terms of the agreement with DOCRO, Affy can enlist the expertise of other CROs to enhance its clinical services unit, if necessary.
“The relationship with DOCRO is non-exclusive and fills an unmet need in the market,” Affy’s spokesperson said. “Affymetrix will continue to seek solutions to help customers realize the goal of enabling molecular-based complex signature assays into the market.”