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Diatherix Buys TEM-PCR from Qiagen to Expand CLIA Lab Offerings, Possibly Develop MDx Kits

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Diatherix Laboratories, an independent CLIA-certified clinical laboratory providing multiplex molecular diagnostic services, said this week that it recently acquired from Qiagen the patent to target-enriched multiplexing, or TEM, PCR — a patent that Diatherix previously licensed from Qiagen for use in its assays.

With the patent in hand, Diatherix, a Huntsville, Ala.-based spinout of the HudsonAlpha Institute for Biotechnology, will now have additional flexibility to develop commercial molecular diagnostic kits based on TEM-PCR or even license the method to other interested parties, Diatherix CEO Dennis Grimaud told PCR Insider this week.

Diatherix also said that it is expanding its space at the HudsonAlpha institute to accommodate such manufacturing and distribution in the future. In the meantime, the company will continue to offer and expand the multiplexed diagnostic panels it had already developed under the previous TEM-PCR license with Qiagen, and will develop new panels for targets such as antibiotic resistance and tuberculosis, Grimaud said.

TEM-PCR uses nested gene-specific primers tagged with a universal set of so-called SuperPrimers to improve the multiplexing of PCR by enabling consistent amplification conditions for different primer sets and eliminating background amplification from high primer concentrations.

"It's an amplification strategy," Grimaud said. "What we use for [nucleic acid] extraction affects the efficiency of our amplification, and we can use different extraction methods. On the detection side, we can also use different platforms — we've done it on a bead array, a microarray, and also on a lateral flow detection platform. Our amplification strategy is so robust that we're not just locked into one detection platform. That's the advantage of TEM-PCR."

The history of the technique extends back to Genaco Biomedical Products, for which Grimaud previously served as CEO. Qiagen acquired Genaco in 2006, primarily for the TEM-PCR technology, and brought to market ResPlex, a multiplexed molecular diagnostic for respiratory disease that Genaco had developed using TEM-PCR.

"I was able to license the technology back to set up a CLIA-certified laboratory [in Diatherix], where we could provide [diagnostic] services," Grimaud said. "That way it wouldn't be directly competitive to Qiagen, which is a product-based company. So, if they had come back into the market with kits, we would be providing services."

Qiagen, however, "was struggling with how to bring this product to market," Grimaud added. "They acquire so many things and are such a big tools company … and in molecular diagnostics, they're branching out into different areas, and this didn't become a priority for them. But it was for me."

As such, late last year Diatherix finalized an agreement with Qiagen that would provide Diatherix with ownership of the TEM-PCR intellectual property.

"Instead of being subservient to Qiagen by licensing the technology, we now own it," Grimaud said. "It gives me an advantage in terms of flexibility. If someone wants to license the technology, I can do that … on a worldwide basis. If we want to … [we] can now develop kits, go through the [510(k) process], and then be able to sell the kits in the open market."

If Diatherix decides to go that route, it will likely be overseas, Grimaud said. To facilitate such an endeavor, the company is still in discussions with Qiagen to reach a distribution and supply agreement that would continue the companies' partnership.

In the meantime, Diatherix will continue to provide diagnostic testing services using its TEM-PCR-based infectious disease panels, as well as expand those panels and develop new ones. Currently the company offers a range of disease-specific panels, including for respiratory infections, bacterial pneumonia, bronchitis, pharyngitis, influenza, Staphylococcus differentiation, urinary tract infections, gastrointestinal disease, and STDs.

"We're definitely looking at the genetic drug resistance side," Grimaud said. When patients are admitted to hospitals, they have to be on antibiotics within two hours. We want to be able to very quickly [determine whether] these organisms have drug resistance, and therefore the patient should not be on those therapies."

In addition, Diatherix "will be going into TB, and the drug resistance associated with TB," he added. "There is also going to be an enhancement to some of our existing panels, where we'll be adding specific targets that will make them much more robust."

As recently as 2011 Qiagen said it was planning a US Food and Drug Administration submission for ResPlex II, a second-generation version of the original ResPlex panel for the detection of respiratory pathogens.

However, a Qiagen spokesperson this week confirmed in an email to PCR Insider that the company no longer sells the ResPlex panel due to the "discontinuation of a needed license" for its commercialization, adding that the agreement with Diatherix had no impact on the discontinuation of the ResPlex panel. Since June, Qiagen has distributed a new respiratory panel based on the QIAsymphony RGQ platform.

Of note, another HudsonAlpha spinout, iCubate, is attempting to commercialize a benchtop, fully integrated cartridge-based molecular diagnostic platform capable of running highly multiplexed assays using the company's amplicon-rescued multiplex, or ARM, PCR method, a version of TEM-PCR. Both ARM-PCR and TEM-PCR were invented by Jian Han, a founder of both Genaco and iCubate (PCR Insider, 12/8/2011).

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