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Life Tech Acquires AcroMetrix to Gain QC Reagents for Real-Time PCR, other Molecular Dx Assays

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By Bernadette Toner

Life Technologies this week said that it plans to acquire privately held AcroMetrix, a provider of quality control reagents for clinical laboratories, blood screening centers, and in vitro diagnostic manufacturers.

Life Tech said the deal, for which financial details were not disclosed, will complement its real-time PCR business in the short term and help expand its presence in the broader molecular diagnostics market in the longer term.

The molecular diagnostics market is currently responsible for around 10 percent of Life Technologies' revenues each year, and the firm has identified the sector as a key growth opportunity.

The AcroMetrix acquisition "is part of about $300 million a year that we do in basic tools and technologies that are sold expressly to molecular diagnostic companies or laboratories," Life Technologies CEO Greg Lucier said during a question-and-answer session following his presentation at the JP Morgan healthcare Conference in San Francisco this week.

Molecular diagnostics is "a great franchise for us, it's growing well, and we want to add to it," Lucier said.

He said that AcroMetrix adds a key technology to Life Tech's molecular diagnostics portfolio at an opportune time. "We see the controls market moving from [being a] very large homebrew [market] today to buying standardized reagents," he said.

AcroMetrix's control reagents are designed to allow labs to standardize tests across systems. Many of the company's products are targeted at blood screening, but it also offers a line of controls for nucleic acid and other molecular tests, including controls for methicillin-resistant Staphylococcus aureus, hepatitis B and C viruses, Epstein-Barr virus, group B Streptococcus, and others.

"At the moment, the majority of labs in this market are developing their own tests and kits," Mark Stevenson, Life Technologies' president and chief operating officer, told PCR Insider. "Those labs that are doing that also tend to develop their own controls — as they make their test, they also make a positive and negative control."

Stevenson said that Life Technologies' market research found that these labs would welcome the idea of replacing their in-house controls with commercial standards.

"With increasing regulation coming into some of the [Clinical Laboratory Improvement Amendment-certified] labs, we see the opportunity and requirement from our customers — who are typically using real-time PCR instruments or sequencers — to add on standards that would enable them to independently check and control their own developed tests," he said.

Customers find commercial standards "to be more efficient than using home-brewed controls, because at the moment they have to make up those controls, and AcroMetrix has a very well-controlled manufacturing environment to make them," he added.

AcroMetrix has headquarters in Benica, Calif., and a facility in Alkmaar, the Netherlands. Stevenson said Life Technologies will continue to maintain these facilities, noting that they are registered with the US Food and Drug Administration and international regulatory authorities. In particular, the Benica site "fits well," given that Life Technologies has several other facilities in the San Francisco Bay Area, he said.

'We See the Growth'

Stevenson said that in addition to the current portfolio of control reagents that AcroMetrix offers, "we thought there was a good synergy for us to connect [the company's products] with our real-time PCR instruments."

He noted that "a natural extension" for AcroMetrix's portfolio would be to manufacture controls for assays that run on Life Tech's 7500 Fast Dx Real-Time PCR instrument.

The system gained 510(k) clearance from the FDA in 2008 for use with the US Centers for Disease Control and Prevention's H5N1 flu panel, and the FDA last April awarded Emergency Use Authorization to offer the test on the platform.

"We're increasingly seeing assays that are being developed for real-time PCR," Stevenson noted. As an example, he cited an agreement that Life Tech signed with Asuragen last year to co-develop that company's BCR/ABL1 assay, which detects and quantifies BCR/ABL1 fusion transcripts to help physicians determine the best treatment for patients with chronic myeloid leukemia.

Life Technologies will market the test, which will run exclusively on the 7500 Fast Dx instrument. According to Stevenson, it "would be another area of making controls" and would move the AcroMetrix franchise into the oncology realm.

Stevenson noted that AcroMetrix got its start in the blood-screening market, but, "increasingly, the opportunity they've been going into is more clinical laboratories and infectious diseases, so that's the area where we see immediate overlap."

Longer term, he said, "their vision is to go into more molecular diagnostics such as oncology applications, and really that's where we see the growth. So we'll continue to supply to the blood centers, but in addition we see infectious disease and oncology as the opportunities for us to grow together here."

Stevenson said that the opportunity for control reagents within the molecular diagnostic market is "not an easy number to come by," but estimated that it's in the range of $200 million to $300 million per year. He said it is "growing because of the increasing requirements from regulatory authorities to use commercial standards."

Life Technologies said that it does not expect the acquisition to have a material effect on its financials in 2010.

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