Brea-based Beckman Coulter Inc. plans to do a clinical study on changes to a heart disease test run on its machines after regulators raised issues earlier this year.
Beckman had withdrawn the test, which detects troponin—a protein released after heart damage—earlier this year after the Food and Drug Administration said the company made changes without obtaining appropriate regulatory clearances.
In its Securities and Exchange Commission filing, Beckman, a maker of instruments and chemicals used by medical laboratories and researchers, said the FDA gave it guidance on the type of information required to get the changed troponin test cleared, as well as goals for any clinical studies.
The FDA is requiring clinical studies of all new versions of the troponin test, Beckman said in its filing, “and we are implementing their guidance.”
Beckman said in its filing that it planned to run the study and submit separate regulatory applications for the troponin test on its DxI and Access medical testing instruments in the first half of 2011.
The company has said dealing with troponin issues could shave $10.7 million to $17.8 million off its 2010 earnings. The company expects profits of $307 million to $321 million, down from a previous outlook of $314 million to $324 million.
CHOC Fundraiser
Children’s Hospital of Orange County is looking to raise $125 million by 2013.
The Orange hospital already has raised $43 million as part of the campaign.
The money in part will go toward a 425,524-square-foot patient tower that’s set to see major construction finish later this year.
It’s also earmarked for an endowment to support the recruitment of pediatric doctors and growing an academic and research affiliation with the University of California, Irvine’s School of Medicine.
The fundraising campaign’s called “Change CHOC, Change the World.”
Leaders include Kimberly Chavalas Cripe, the hospital’s chief executive, and philanthropist Sandy Segerstrom Daniels, the campaign’s honorary chair.
The hospital already has gotten some donations from various businesses and individuals that are worth $1 million or more, according to CHOC.
A good portion of that money will be funneled to the hospital’s planned $563 million expansion.
The patient tower initially is set to add about 90 beds at the hospital for an eventual total of 404 in 640,524 square feet of space.
The tower, which will feature private rooms, is scheduled to take its first patients in early 2013.
Costco Wholesale Corp. gave a donation for a surgical suite in the tower and a Da Vinci robotic surgical system.
UCI Studies Miscarriages
A University of California, Irvine, professor and colleagues recently found that stress caused by psychological shock from the 2001 terrorist attacks may have led to an increase in male children being miscarried.
UC Irvine professor Tim Bruckner and colleagues from the University of California, Berkeley, found that the death rate for male fetuses spiked in September 2001, and that significantly fewer boys were born than expected in December 2001.
In a statement, Bruckner said that the findings appear to demonstrate the theory of “communal bereavement.”
Communal bereavement holds that societies may react adversely to unsettling national events despite having no direct connection to persons involved in those events.
The professor also said that stressful times reportedly reduce the male birthrate across many species, and that it’s commonly thought to reflect a natural selection function to improve the mother’s overall reproductive success.
Study results were reported in BMC Public Health, an online journal.
Allergan Eye Drug Cleared
Allergan Inc., the Irvine drug maker, received Food and Drug Administration approval for Zymaxid, a drug to treat eye infections.
Zymaxid, which Allergan is launching in June, is for eye infections caused by several different organisms.
Allergan developed Zymaxid, which it called a “more potent formulation” of an anti-infective drug, because some bacterial infections were becoming resistant to existing drugs.
Bits and Pieces
Irvine drug maker Spectrum Pharmaceuticals Inc. said that clinical data on its belinostat drug candidate would be presented during an annual meeting next month in Chicago of the American Society of Clinical Oncology. Spectrum is looking at developing belinostat to treat various types of cancers, including T-cell lymphoma, a blood cancer … InSight Health Services Holdings Corp., a Lake Forest-based medical imaging company, said it picked Warminster, Pa.-based MobileMD Inc. as a provider of health information exchange services. InSight will use MobileMD’s software to provide its doctors access to clinical information, among other things … Newport Beach-based medical group Greater Newport Physicians said it received a four-star elite status award from the California Association of Physician Groups.
