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Swift Biosciences Launches BRAF Mutation Assay; Tacks on $2.4M to Series A Financing Round

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This article has been updated from a previous version to correct a numerical error.

By Ben Butkus

Swift Biosciences this week announced the formal commercial launch of its first product, a BRAF mutation-detection assay based on the company's proprietary "myT Primer" qPCR reagents.

In addition, company officials told PCR Insider this week that it has raised $2.4 million in private financing, a follow on to the $3 million Series A financing that Swift completed in August 2010.

Swift will use the funding to support marketing efforts around its new BRAF mutation-detection assay, as well as to continue developing other myT Primer-based products, including an even more sensitive version of its BRAF test and a similar assay for KRAS mutation detection.

Founded in 2010 in Ann Arbor, Mich., Swift has developed a PCR primer chemistry that affords an extremely high degree of sensitivity and specificity due to a unique physical configuration that allows the primers to function only in a very narrow thermodynamic window.

At least year's Molecular Medicine Tri-Conference in San Francisco, Swift scientists presented a pair of posters demonstrating the robustness of the company's two first myT Primer assays: one for the seven most frequent KRAS mutations, and one for the two most frequent BRAF mutations (PCR Insider, 2/23/11).

In model tube-based assays, the myT Primer assays were able to detect a single copy of mutant template molecule without amplifying any of the approximately 14,000 wild-type copies of genomic DNA over 55 cycles.

According to the company, these results were "several orders of magnitude" higher than those achieved using a "leading commercially available KRAS qPCR mutation test kit," most likely Qiagen's TheraScreen K-RAS.

Since that time, the company has also demonstrated how its assays can be used with clinical samples, such as formalin-fixed paraffin-embedded tissue from colorectal cancer and melanoma specimens. It has also worked to bundle the assays into commercial offerings optimized to work with several industry-leading detection chemistries and real-time PCR instrument platforms. Swift formally launched the first of these products, the myT BRAF assay, at this year's Molecular Medicine Tri-Con, held this week in San Francisco.

"The products … are not what we would call a full PCR kit in that they do not contain master mix [or] a fluorophore or some detecting material," CEO David Olson told PCR Insider recently.

"We're basically providing the amplification oligos, and then we have recommendations on [commercially available] master mixes that folks can use … and a recommendation on a detection probe."

Those recommendations, which are included in the assay protocol, include master mixes from Fermentas and Agilent; and real-time PCR instruments such as Life Technologies' ABI 7500, Roche's LC 480, and Bio-Rad's CFX 96, Olson said.

"Those are just the ones that we found, in our hands [and] with those instruments, would be a good place for customers to start," Olson said. "We certainly haven't tried all instruments or all mixes. Undoubtedly the experience we're hearing from customers in the field is that they'd like to figure out what works best for them."

Olson added that this approach is consistent with Swift's corporate strategy. "We're trying to produce products that will work on existing instrumentation, and are broadly applicable to help customers do things with their existing instruments that they couldn't do before," he said. "We try to do that by providing proprietary reagents and the protocols that go with them."

In general, myT BRAF can detect 1 percent mutant BRAF V600E/K in a background of 103 wild-type genomic DNA copies with no breakthrough amplification from wild-type. The assay works with either FFPE or fresh frozen samples, and each myT BRAF package includes sufficient reagents to assess up to 28 samples plus a positive and negative control.

Olson said that Swift has had interest in the kits from prospective customers and beta testers "from several different angles." Two potential customers, he said, are interested in using them in clinical and companion diagnostic research in solid tumor samples. "And we've had a significant amount of interest and activity from folks who are interested in detecting things in the blood, which includes circulating tumor cells, as well as other blood-based assays [for] genetic biomarkers."

One early-access customer of myT BRAF who wished to remain anonymous due to competitive concerns said that their group is "currently collaborating with Swift Bioscience to develop a serum- and/or plasma-based assay to detect BRAF V600E mutation in melanoma patients. Due to the low abundance of BRAF V600E mutation in patient circulation, we believe that the myT primer technology might provide us with the sensitivity and specificity we are looking for."

Olson said that potential customers are considering using the myT products because "existing products are too complicated and expensive to use;" while others have noted that there are really "no products that are able to achieve their objectives. We see that more in the CTC space and blood-based diagnostics."

Olson did not disclose a price range for the myT BRAF assay, but noted that the company expected to distinguish itself from competitors in the area of assay cost. Many other companies — including Qiagen, Life Technologies, Transgenomic, Panagene, and Seegene — offer kits for BRAF and KRAS analysis. In addition, Exiqon licenses out its Locked Nucleic Acid technology to companies to develop mutation detection assays for genes such as KRAS and BRAF.

"One of the things that we've heard are that some of the other products out there are above the price range that [potential customers] are comfortable with," Olson said. "And in many cases they are trying to build their own assays to try and avoid that. And that's one of the reasons we want to provide them with a reagent that they can build their own assays around that allows them to achieve performance they wouldn't have with conventionally designed assays."

In the "coming soon category," Swift will market myT BRAF-Ultra, an ultrasensitive version of myT BRAF that will provide 0.01 percent sensitivity — and even single-copy capability — with very low breakthrough amplification from wild-type, Olson said. This level of sensitivity will make the assay ideal for use when sample material is limiting or target is present at very low concentrations, such as with CTCs, serum, plasma, and needle biopsies.

"There are customers who are interested in finding a needle in a haystack … and the myT BRAF-Ultra is specifically designed for that objective," he said.

In addition, Swift is currently developing a set of myT KRAS primers for detecting mutations in codons 12 and 13. Olson did not provide a commercialization timeline for myT BRAF-Ultra or myT KRAS.

Further down the road, Swift would like to begin moving its technology into clinical applications, and to that end is currently "in discussions" with potential clinical partners.

Separately this week Olson said that Swift recently raised $2.4 million in private financing, bringing the total amount raised by the company since its inception to $5.4 million. Swift did not disclose participating investors. Venture firm DFJ Mercury led the first $3 million of the Series A round in 2010.

Olson said that Swift has recently expanded to 10 employees from six in 2011, and plans to add "another few" employees over the next year.


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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