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Amersham, Bayer Dx Take Aim at ABI, Abbott With Threat of New High-Throughput HIV IVD

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By teaming with Bayer to develop in vitro diagnostics for HIV drug resistance, Amersham Biosciences is hoping to take aim at one-time rival Applied Biosystems in a large and steadily growing market.

The move will also pit Bayer, the No. 3 diagnostic manufacturer, against Abbott Labs, the No. 2 shop, in a largest corner corner of the $50 million HIV-resistance space.

Trouble for Amersham and Bayer is that ABI and corporate kin Celera Diagnostics already have a trio of platforms approved for this indication. Are Bayer and Amersham too far behind?

To be sure, Bayer’s Trugene tests for HIV drug resistance already challenge the ViroSeq platform manufactured by Celera Diagnostics and marketed worldwide by Abbott Labs. But the ViroSeq test is available in three distinct throughput categories and plays in three markets. Trugene to date just sells to two.

This is where Amersham’s MegaBace sequencing platform comes in: Bayer hopes the technology will help it launch Trugene into the most competitive of the three markets: the $10 million large-volume reference-lab arena.

“It’s our goal to use the Amersham MegaBace platform [to] take the Trugene test to the next level,” Peter Knueppel, senior vice president of molecular diagnostics at Bayer, told SNPtech Pharmacogenomics Reporter this week. “This is a very flexible technology, and we want to populate this platform with new assays [that are] FDA and CE Mark approved.”

Currently, the Trugene test, which was cleared by the FDA in September 2001, is sold to low- and medium-throughput labs in the United States. These labs, which comprise university medical centers and large clinics, comprise between 50 percent and 60 percent of global the HIV-resistance market. The entire space is worth around $50 million, and is believed to be growing between 13 percent and 15 percent annually, according to an annual market-research report by Frost & Sullivan. Approximately 150,000 HIV genotyping tests are performed each year, Celera Diagnostics said on its website.

Knueppel said Bayer’s move into the high-throughput space, which comprises big reference labs such as Quest Diagnostics and LabCorp, is in its early days, and that neither Bayer nor Amersham expect to have a product available for US regulatory approval before this time next year. (Knueppel said a high-throughput Trugene test would be applied for European regulatory approval after it is cleared for sale in the United States.)

He would not comment on the cost of the Trugene test in any of its existing markets. However, Timothy Alcorn, director of molecular pathology at Esoterix and a former director of infectious diseases at LabCorp, said Bayer and Abbott charge between $350 and $450 for their assays.

Knueppel said that home-brew tests made by the large reference labs would be Bayer’s greatest rivals, but added that Celera’s ViroSeq will also be a major competitor.

Celera and Abbott have a clear advantage over Amersham and Bayer. In June, the US Food and Drug Administration gave the green light to the Applera unit and its big pharma partner to market the ViroSeq platform on the ABI Prism 3700 instrument to large reference labs. A Celera Diagnostics spokeswoman said at the time that the company had customers for this version of the product, but declined to say who they are.

This approval initially took root last February when the FDA allowed the ViroSeq platform to be used on ABI’s Prism 3100 gene analyzer and sold to regional medium- and high-throughput labs. Two months earlier, the FDA allowed ViroSeq to be used with ABI’s Prism 377 sequencer. This permitted Abbott to begin selling the assays to low-throughput labs like university hospitals.

In another victory over Bayer and Amersham, Celera and Abbott last week were told by the FDA that they can use an updated algorithm that will enable the ViroSeq product to test for resistance to against four additional antiretrovirals: Gilead Sciences’ Viread (tenofovir), Reyetaz (atazanavir), and Emtriva (emtricitabine); and GlaxoSmithKline’s Lexiva (fosamprenavir). This latest 510(k) clearance covers the use of the ViroSeq system with the 3700 platform, for high-throughput clinical testing labs, and the 3100, for regional medium- and high-throughput labs. In an e-mail message, Knueppel said Trugene “provides resistance interpretation for all” FDA-approved protease inhibitors and reverse transcriptase inhibitors.

Esoterix’s Alcorn said Trugene and ViroSeq may have a difficult time gaining traction in the reference lab market. For example, LabCorp uses ABI technology to develop home-brew tests, but does not use the ViroSeq product.

On the other hand, reference labs are generally not inclined to develop home-brew assays based on CLIP sequencing technology, which is central to Trugene.

Alcorn added that the Trugene assay is “fairly inflexible in terms of its multifunctionality, so I would guess that if I were Bayer I’d be looking for maintaining some sort of foothold or getting at least some play in the big reference labs by having a platform that is more user-friendly and more flexible,” he told SNPtech Pharmacogenomics Reporter this week. He said he thinks Amersham’s MegaBace would accommodate this.

— KL

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