Sequencing and Analysis of the Hydra Genome
Chapman, Kirkness et al., Nature
An international research collaboration reports their sequencing and analysis of the Hydra magnipapillata genome, and compare it to the genomes of several other organisms. "The Hydra genome has been shaped by bursts of transposable element expansion, horizontal gene transfer, trans-splicing, and simplification of gene structure and gene content that parallel simplification of the Hydra life cycle," the authors write. They team suggests that comparisons of the Hydra genome to the reported sequences of other animals have helped them to elucidate the evolution of several of the organism's characteristics.
LabCorp Hints Its OvaSure Assay Remains in Play as Quest Readies OVA1 IVD for Launch
September 22, 2009
This updates corrects an earlier version that mistakenly referred to Quest and Vermillion’s OVA1 ovarian cancer-risk test as the OvaCheck.
With Quest Diagnostics preparing to launch Vermillion’s OVA1 assay during the fourth quarter, LabCorp is hinting that it still hopes to revive its own short-lived ovarian cancer-risk test.
Last week Vermillion and Quest said FDA approved OVA1, which is designed to help physicians identify women at risk for having a malignant pelvic mass prior to surgery.
Vermillion and Quest co-developed the five-biomarker IVD, and Quest bought exclusive rights to offer it to US clinical labs for three years.
But for a short time last year LabCorp was first to market a similar test, the OvaSure, but eventually succumbed to FDA pressure to pull it from the market.
This morning, a LabCorp spokesperson told me via e-mail the company “will continue to engage in discussions with the FDA” regarding the OvaSure.
LabCorp launched the six-biomarker immunoassay as an LDT in June 2008. The test, co-developed with researchers at Yale University School of Medicine, was designed to assess early-stage ovarian cancer in high-risk women.
Two months later FDA sent LabCorp a warning letter saying OvaSure was “misbranded” because certain of its parts were not developed by the company, and that it deemed it an IVDMIA — a category that remains in a murky purgatory (more on that later).
In October of that year, LabCorp fought back, saying it would continue marketing the test because it “meets all applicable CLIA regulatory requirements.” But a few days later the reference lab reversed course and pulled OvaSure from the market.
However, it said it disagreed with FDA’s contention that it needs the agency's approval before it can launch the test, and said it had requested a meeting to discuss the matter. That was this time last year.
This morning, LabCorp said it is “an industry leader in responsible scientific innovation” and “is still very supportive” of OvaSure, though added it “cannot comment on the regulatory pathway at this time.”
The National Cancer Institute estimates that around 212,000 new cases of ovarian cancer will be diagnosed in 2009. The total number of women with ovarian tumors is not known, according to Fred Ueland, principal investigator on Vermillion’s OVA1 and an associate professor gynecologic oncology at the University of Kentucky. However, he estimated the number to be between 32 million and 37 million.
While most of the tumors are not malignant or are resolved without surgery, “it’s very important that women with ovarian cancer be referred to a gynecologic oncologist before surgery,” Ueland told Sample sister publication ProteoMonitor in July 2008, one month after LabCorp debuted OvaSure.
As for FDA’s current IVDMIA stance, the agency may have to go back to "square one," according to Alberto Gutierrez, the newly appointed director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.
Speaking during a health-care conference last month, Gutierrez said "[t]here is a lot of uncertainty [over IVDMIAs] because healthcare has runaway costs and this administration [of President Barack Obama] wants to do something about it.”
