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BlueGnome Spinout Sure Laboratories Aims to Serve Growing IVF Screening Market

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By Justin Petrone

Cytogenetic array maker BlueGnome this week announced that it has spun off Sure Laboratories, an independent clinical cytogenetics services company.

The new firm was founded to take advantage of a "rapidly growing" market for pre-implantation genetic screening services, BlueGnome said.

Sure Laboratories will directly offer BlueGnome's 24Sure platform, which relies on a BAC array and software to screen for abnormal or aneuploid chromosomes, to in vitro fertilization centers in Europe. Both BlueGnome and Sure Laboratories are located in Cambridge, UK.

24sure is used to confirm that eggs and embryos contain the correct number of chromosomes. Aneuploidy is considered to be a source of infertility, and by identifying such cells in an IVF cycle it may be possible to improve IVF success rates, according to BlueGnome.

Graham Snudden, vice president of engineering at BlueGnome, said that the firm saw the need to launch an independent laboratory-services company following the debut of 24sure last year.

"That has its roots in our 24sure screening service," Snudden told BioArray News this week. "The IVF labs tend to want that provided as a service as they don't want to be running an array lab at the same time. They were very keen that we set up a service and that has worked successfully, grown rapidly, and it is fundamentally a different business. It seemed sensible to give it its own life as an independent company."

The firm has positioned 24sure as a first-tier screen for embryos during an IVF cycle, a complement to the standard first-tier technology for aneuploidy screening, fluorescent in situ hybridization, which is only capable of screening for a limited number of chromosomes at a time. BlueGnome's approach has been evaluated by several IVF centers, including the Nottingham, UK-based CARE Fertility Group (BAN 9/8/2009).

CARE Managing Director Simon Fishel said in a statement this week that the facility has been a customer of Sure Laboratories, and that the 24sure approach has "significantly enhanced implantation rates" and "minimized the risk of multiple pregnancies for our patients."

Snudden declined to name other IVF customers, though he said that "99 percent" of the samples handled so far have come from within the UK, with the rest coming from elsewhere in Europe. He noted that IVF screening is a "highly commercial, very competitive business," and that pre-implantation genetic screening is "growing rapidly."

"We are optimistic about the market," Snudden said. Though 24sure is "not an established technology by any means," BlueGnome felt there was "sufficient interest to invest in the company."

The 24sure service includes BlueGnome's BAC CytoChip technology coupled with SurePlex amplification systems licensed from Rubicon Genomics, and BlueFuse Multi software, plus the firm's library of over 26,000 FISH probes for follow-up investigations. Customers currently access the 24Sure service to look at up to eight cells for £1,800 ($2,970).

Sure also advertises on its website the availability of cytogenetic screening services on an Agilent Technologies-manufactured CytoChip oligo array that is compliant with designs set by the International Standards for Cytogenomic Arrays Consortium; a BlueGnome's CytoChip Focus Constitutional array, which is focused on genetic disorders; and a CytoChip Focus Hematology array, which screens more than 50 genomic regions associated with known hematological malignancies.

Snudden stressed that 24sure is the laboratory's main offering, and that the company is "exploring" the addition of the other CytoChips to its testing menu. Sure Laboratories is also undertaking Clinical Pathology Accreditation and is seeking to operate in line with the International Organization for Standardization's 15189 standard, which provides requirements for quality and competence in the management of medical laboratories.

BlueGnome co-founder and CEO Nick Haan is currently acting CEO of Sure Laboratories. Snudden said the firm is hiring lab technicians and other personnel to staff the company.

BlueGnome announced in June that 24sure had been evaluated by a team of researchers from the European Society of Human Reproduction and Embryology's task force on pre-implantation genetic screening for implementation in IVF cycles.

The group found that 24sure could predict abnormalities in 89 percent of cases surveyed. The study also confirmed that results were available within 12 hours, enabling 24sure to be used in a fresh IVF cycle (BAN 6/29/2010).

Haan said at the time that BlueGnome had processed more than 200 consented clinical cases using 24sure and had "demonstrated a significant increase in the success of pregnancies within this challenging group of patients." He said the firm has been working with IVF centers in "over 15 countries to ensure that 24sure is widely available as we await publication of further studies into its clinical efficacy."

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