|Dako received an FDA warning letter over how it manufactures the HER2 CISH pharmDx kit and other tests.--Courtesy of the FDA|
Diagnostics giant Dako got an earful from the FDA over how it manufactures test kits at a Denmark plant, including the company's high-profile companion diagnostic for Roche's ($RHHBY) blockbuster Herceptin breast cancer treatment.
In a warning letter dated Aug. 21, the FDA chides Dako for failing to adequately address manufacturing problems identified in an earlier inspection, including corrective and preventive actions, process validation, evaluating complaints and reporting failures.
Dako has 15 business days to respond to the letter and detail how and when it plans to fix the identified issues. If the FDA remains unsatisfied, it can bar Dako from importing products made at the plant, which include the agency-approved HER2 CISH pharmDx kit, a Herceptin companion diagnostic.
Dako and parent company Agilent ($A) are taking the FDA's concerns seriously, the company said in a statement, and they're committed to addressing each issue detailed in the warning letter.
"Naturally, Dako will do all it takes to remedy the situation, building on the experience gained from the more than 20 inspections successfully passed at the Dako facility over the past two years by different international authorities and partners," a spokeswoman said.
The company isn't commenting further on the issue or detailing which of its other tests are made at the plant.
In March, Dako found more success in its longstanding partnership with Roche, winning FDA approval for two tests matched with Kadcyla, a Herceptin successor analysts predict will pull in between $2 billion and $5 billion a year.
Since getting bought for $2.2 billion last year, Dako has had little trouble nailing down Big Pharma partnerships, signing deals with with Pfizer ($PFE), Eli Lilly ($LLY) and Amgen ($AMGN) to develop diagnostics for oncology drugs.
- read the warning letter
- check out FierceDiagnostics' take