By Kirell Lakhman

The FDA's Center for Devices and Radiological Health expects to complete relocating to its new Maryland digs Aug. 3, and is urging researchers not to file regulatory submissions on certain days.

Because the center will be moving on all Fridays, Saturdays, and Sundays other than holiday weekends, it "will not officially receive premarket submissions on the Friday of a move … and the Monday after a move weekend."

In a statement, CDRH says that until it finishes its move "the best way" to reach its staff is by e-mail "because all office addresses, phone and fax numbers will change." Accompanying the statement is a list of phone numbers and two e-mail addresses.

Researchers looking to submit tests for 510(k), IDE, PMA, 513(g), Pre-IDE, PDP, HDE, and CLIA review should use these snail-mail addresses.

Since mid-May, CDRH has been moving from various Rockville, Md., locations to the FDA's main White Oak campus at 10903 New Hampshire Avenue in Silver Spring, Md.

The center says questions should be addressed to Marjorie Shulman at 240-276-4186 or Marjorie.shulman@fda.hhs.gov.

The GWDN Index climbed 6 percent as tech stocks rallied during the month. Monogram Biosciences was the biggest gainer for the month, due to its acquisition pact with LabCorp.

BlueGnome will use the PicoPlex in its SurePlex DNA Amplification system.

By Kirell Lakhman

The Association for Molecular Pathology earlier this week released five "key principles" the federal government should keep in mind as it tries to revamp the nation’s health-care system.

Saying it "supports efforts to achieve comprehensive health-care reform," AMP is urging the government to "adopt measures that will strengthen the practice of laboratory medicine and the availability" of lab tests.

In a four-page statement, the group recommends that "all health plans" should cover clinical lab tests, particularly "preventive and early diagnostic services," and says tests "should be reimbursed in a manner commensurate with the added value and savings they contribute to health care delivery."

The recommendations also say that comparative effectiveness review practices "must include molecular-based laboratory tests," and that regulation of molecular-based lab tests "should be done in a balanced way that will allow progress and innovation in the field to continue and not place undue burdens on a currently well-regulated practice."

In a news release dated June 29 but issued today, AMP President Jan Nowak said the group “strongly supports comprehensive health care reform" and that "laboratory medicine has an indispensible role to play in making the health care system more efficient, in improving the quality of patient care, and in advancing the new era of personalized medicine.”

Three genome-wide association studies published in Nature's early online edition show that many common variants contribute to increased risk for developing schizophrenia -- not just large, rare structural variations. In total, says a BBC story, the scientists identified 30,000 variants, highlighting SNPs found on genes in the MHC on chromosome 6. The studies were led by or used data from the International Schizophrenia Consortium, the Molecular Genetics of Schizophrenia consortium, SGENE, Decode Genetics, and the Genetic Risk and Outcome in Psychosis study.

This week's cover story reveals how salamanders regenerate lost limbs. "Because the cells that collect in the blastema look identical, it has long been thought that they have dedifferentiated from tissues near to the plane of amputation into a single population of pluripotent cells," says a News and Views perspective. Not so. According to work led by German scientist Martin Kragl, researchers found that, by tracking limb tissues using an integrated GFP, the cells do not become pluripotent and have restricted differentiation potential.

Several articles take a look at the state of iPS cell generation. Shinya Yamanaka reviewed the bottlenecks in the process, and proposes that "most or all cells have the potential to become pluripotent." A study from Spanish scientists led by senior author Juan Carlos Izpisúa Belmonte showed that somatic cells from Fanconi anaemia patients can be reprogrammed to pluripotency to generate patient-specific iPS cells. Another study led by Partners' Kenneth Chien used transgenic and gene-targeting approaches to find that human fetal ISL1+ cardiovascular progenitors that can differentiate into the cardiomyocyte, smooth muscle, and endothelial cell lineages are also able to self-renew before the differentiation process. A third revealed that two interacting leukemia inhibitory factor (LIF) signaling pathways can control pluripotency in mouse ES cells. Others provide even more insight.

Finally, a Nature Methods paper led in part by Norbert Perrimon and Bonnie Berger presents RNAiCut, an automated method to identify hits by incorporating protein-protein interaction data. "This tool will help functional genomics research by enabling hit-list gene selection using orthogonal datasets," they say.