Invitrogen Swings to 3Q Loss:

Earnings Season

Oops = Invitrogen Swings to 3rd-Quarter Loss on Hefty Charge; Shares Slide on Wall Street Miss.

Chaos in Carlsbad?

Invitrogen Swings to 3Q Loss: Financial News - Yahoo! Finance

Applied Biosystems president joins Kinetic Concepts |

BOSTON, Oct 20 (Reuters) - Applied Biosystems Inc. (ABI.N: Quote, Profile, Research), a maker of tools for genetic research, said on Friday that its president, Catherine Burzik, has resigned to become chief executive of medical device company Kinetic Concepts Inc. (KCI.N: Quote, Profile, Research).
Foster City, California-based Applied Biosystems, whose parent is Applera Corp., said Tony White, Applera's chairman and chief executive officer, will become interim Applied Biosystems, president.
Kinetic Concepts, based in San Antonio, Texas, specializes in making wound-care products, specialty hospital beds and mattress replacement systems.

Applied Biosystems president joins Kinetic Concepts |

FDA Claims Six of Qiagen's Molecular Dxs Should Have Undergone Agency Review

NEW YORK (GenomeWeb News) — The US Food and Drug Administration has sent a letter to Qiagen warning it that certain of its molecular diagnostics currently sold in the US do not have regulatory approval.

In an Oct. 2 letter to Qiagen CEO Peer Schatz, the FDA said six diagnostic products Qiagen developed are improperly marketed and require regulatory review by the agency. On its we site, Qiagen stresses that the products — tests for herpes virus, lime disease, parvovirus, Chlamydia, and malaria — are designed for use in CLIA labs and therefore do not require FDA oversight.

The FDA, on the other hand, claims that because the tests are packaged with instructions they are subject to agency review.

Products affected include Artus CMV PCR, C. Trachomatis PCR, C. Trachomatis Plus PCR, Parvo B19 PCR, Borrelia PCR, and Malaria PCR analyte specific reagents.

BioBOOM Op/Ed: Predict that this is going to hurt as the big difference in thier growth the past quarter verses the other competitors was primarily due to efforts in MDx

Medicare slammed for not improving lab-quality rules - Nation/Politics -

Medicare slammed for not improving lab-quality rules - Nation/Politics - The Washington Times, America's Newspaper: "Some scientists and consumer health groups are angry that the U.S. Centers for Medicare and Medicaid Services (CMS) has decided not to write new rules designed to improve the quality of laboratories that perform genetic testing, keeping in place current guidelines.
'We're very disappointed,' said Rick Borchelt, spokesman for the Genetics and Public Policy Center. 'After years of saying they were going to do this, they did a complete about-face ... with no justification. We're mystified.' "