FDA Approves Affymetrix Post-Natal Test

Shares of Affymetrix (NASDAQ: AFFX  ) rose by 2.4%, or $0.22, in after-hours trading following a nod from the Food and Drug Administration on Friday. In a press release, the FDA said it had given the green light for the company to market its CytoScan Dx Assay, a post-natal test that aids in the diagnosis of developmental and intellectual difficulties in infants.

The test works by detecting chromosomal variations, the presence of which could indicate such problems.

The approval was effected through the FDA's de novo process, a system used for certain devices that the FDA determines carry low to moderate risk.

The news comes just over one week after Affymetrix released its preliminary Q4 and fiscal 2013 revenue figures. For the quarter, the company expects total revenue of roughly $91 million, while for the full year that line item is anticipated to come in at $329 million.

The company is scheduled to release its official figures for the quarter and year on Feb. 5.

Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2800461, ~/Articles/ArticleHandler.aspx, 5/29/2015 10:41:43 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...