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NewGene Looks to Shake up BRCA Market with Next-gen Sequencing-based Test

By Tony Fong

NEW YORK (GenomeWeb News) – A UK firm founded three years ago is looking to shake up the BRCA testing market.

In mid-2010, NewGene, based in Newcastle upon Tyne, launched its next-generation sequencing-based BRCA1 and BRCA2 testing service for breast cancer in the UK. Initially, the test is being targeted to patients with a family history of breast cancer with a longer-term goal of developing it as a general screen for the disease.

Since its launch, the company has been refining the test, reducing the turnaround time, and improving production procedures. As NewGene ramps up adoption of the test in the UK, it is now eyeing the rest of Europe, and further down the road it hopes to bring the test to the US.

In doing so, the company would be tackling a space that is dominated by one firm, Myriad Genetics, which has been vocal about its plans to move into the European market. Unlike Myriad's test, BRACAnalysis, which is PCR-based, NewGene's assay uses next-gen sequencing technology that, according to company officials, results in faster turnaround times and lower costs, compared to other technologies.

And that, the company said, will lead to improved access to a breast cancer genetic test with clinical use for patients.

The NewGene test is based on full gene sequencing of the BRCA1 and BRCA2 genes, "so we're not targeting specific mutations, we're sequencing everything, at least the coding sequence," Ann Curtis, scientific director of the firm, told GenomeWeb Daily News.

The NewGene approach uses pyrosequencing, which from a diagnostic perspective is a new method of sequencing, especially in the UK, Curtis said. However, NewGene is not the only firm employing pyrosequencing for diagnostic uses. Qiagen, for example, in 2008 purchased the biosystems business of Biotage, which included pyrosequencing technology that Qiagen is now using for molecular diagnostics development.

NewGene is the first laboratory in the UK to use such an approach, Curtis noted, "and the significance is that it allows us to sequence more patients in a faster turnaround time for a lower cost than is currently on offer."

The company uses the Roche 454 GS-FLX platform for the pyrosequencing.

Unlike traditional Sanger sequencing, which involves looking at individual segments of a gene one segment at a time and one patient at a time, NewGene's approach enables the investigation of genes of interest in multiple patients in the same run and with multiple gene fragments in the same run.

The result is that in one run, NewGene can look at 20,000 fragments, as opposed to one fragment per run allowed by Sanger sequencing-based methods, Curtis noted. Because each patient requires about 100 fragments to be sequenced, the increase in the number of patients that can be investigated in a single run and the improvement in throughput achieved by NewGene's technology is significant, company officials said.

According to NewGene, test results using its technology can be achieved in as little as four weeks, compared to the eight weeks targeted by the UK National Health Service. In actuality, NewGene added, the wait time for test results using other technologies can be even longer.

Currently, the company can do about 80 patients per machine-run, and "that could be scaled up," Curtis said.

The company has targeted patients with a family history of breast cancer as its initial market, which in the UK is about 8,000 patients each year, said Jonathan Robinson, NewGene's business development manager. Around 40,000 new cases of breast cancer in total are diagnosed in the UK annually, and eventually, the company hopes the test will be used as a general screen for the disease.

In order to do that, the test will have to be developed so that its cost — the median price is £600 ($969) and goes up or down depending on the level of testing — goes down while its speed increases.

The test is reimbursed in the UK, and NewGene Chief Executive David Huntley said that its future as a screening platform may eventually come down to healthcare economics and whether the NHS decides using the test as a screen would result in savings for the agency.

Currently two of the approximately 30 regional genetic centers in the UK provide NewGene's test, and its first priority is to get higher market penetration in the UK. However, it also is getting set to bring the test into other markets in Europe, and Huntley said that NewGene has been approached by healthcare players on the continent about the test, though he characterized efforts to expand its footprint to other geographies as "passive activity."

A US launch, he added, is not currently targeted while the company tries to stay closer to its home base. "It's in our objectives, but I would say it's a much longer term objective," Huntley said.

Taking on Myriad

A US launch of its test would also put it head to head with Myriad Genetics, which dominates the BRCA1 and BRCA 2 testing space with its BRACAnalysis product and has aggressively sought to keep control of the US market by enforcing its IP rights on the two genes. It currently is appealing a decision by a federal court invalidating certain of the company's BRCA gene patents.

Myriad also is preparing to enter the European market, and during the JP Morgan Healthcare Conference in January, Myriad officials moved up the intended timeline for a European introduction to 2012 — although Myriad CEO Peter Meldrum said that the UK is not a market that the firm is currently considering because of reimbursement issues, and instead is looking at other countries such as Germany, Italy, and France.

In Europe its BRACAnalysis test is protected by five patents. However, Myriad has not enforced its European patents, and during its fiscal second-quarter earnings conference call in January, Meldrum said that he didn't believe that entering into a new market "in a heavy-handed fashion trying to enforce patents," would be the right approach. Instead, the company would rely on other competitive advantages BRACAnalysis holds in order to gain the upper hand over companies in Europe offering BRCA testing.

Huntley had little to say about the impact he expects NewGene's test would have on Myriad's plans for Europe and vice versa, saying he didn't know enough about BRACAnalysis or Myriad's strategy.

In addition to its BRCA tests, NewGene offers five other assays. The test for KRAS mutation; EGFR mutation; BRAF mutation; and JAK-2 and MPL mutation are run on Sequenom's MassArray mass spectrometry platform. The BCR-ABL mutation test is run on Roche's LightCycler PCR system.

The company also plans to launch a test for muscular dystrophy in the UK in April, and other tests in the pipeline include those for melanoma, hereditary non-polyposis colorectal cancer and familial adenomatous polyposi, and atypical hemolytic uremic syndrome, Robinson said. Those tests will also be based on Roche 454 sequencing.

NewGene uses that platform largely because of its ability to run multiple tests. The system also can be used to read long stretches of DNA compared to other platforms, "and we feel that that is much better for diagnostics than the other platforms, [which] are probably more appropriate for research work," Curtis said, though she added that in the medium term, NewGene may explore other next-gen sequencing platforms.

In connection with that, Huntley noted that one of the company's missions is to bring the benefits of next-gen sequencing to the NHS. NewGene was spun out of Newcastle University about three years ago and is now jointly owned by the university and NHS. NHS provides the majority of funding to NewGene.

For its fiscal-year 2012, which will start in April, the company anticipates generating more than £1 million in sales, Huntley said.

All of NewGene's tests are offered as services with testing done at NewGene's facility, and the firm plans to continue doing so as it expands to areas surrounding the UK. Depending on where the company expands, though, it may license its technology out to other firms or healthcare organizations to do the testing.

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