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MDx/CDx Focus: Epigenomics Septin9 Deal; BRCA MASTR Dx Gets CE Mark; Xalkori Phase III Study Results

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Epigenomics Grants Non-Exclusive License for Septin9 Biomarker to Texas-Based Lab Test Provider

Epigenomics and Companion Dx Reference Lab have signed a non-exclusive licensing agreement that gives Companion Dx the right to use Epigenomics’ proprietary methylated Septin9 biomarker to commercialize a blood-based, laboratory-developed test to detect colorectal cancer.

Under the terms of the licensing agreement, Epigenomics could receive up to double-digit royalties on sales.

“The addition of Septin9 to our offering of cancer-related products will allow us to more effectively serve the Texas cancer testing market,” Companion Dx CEO Steve Blum said in a statement. Companion Dx is located in the Biotechnology Commercialization Center of the University of Texas Health Science Center in Houston. Noting that colorectal cancer is among the leading causes of cancer deaths in the US, Blum added that a blood-based testing method to detect the disease will help improve outcomes for patients by identifying those who need to get more invasive screening.

“With today’s licensing agreement, we continue to execute on our commercialization strategy, well ahead of the launch of a proprietary diagnostic product approved by the FDA”, Noel Doheny, CEO of Epigenomics’ US subsidiary said in a statement.

In addition to the agreement with Companion Dx, Epigenomics’ holds licensing deals for the Septin9 biomarker with Quest Diagnostics, ARUP Laboratories, and Warnex Medical Laboratories in North America. Abbott Molecular holds a worldwide, non-exclusive license to develop and commercialize IVD test kits using the Septin9 marker.


Multiplicom Garners CE Marking for BRCA Dx Based on Massively Parallel Sequencing

Molecular diagnostics firm Multiplicom announced that it has established CE accreditation for its BRCA MASTR Dx in Europe.

The multiplex PCR-based test can be combined with any massively parallel sequencing-based platform to identify mutations in the coding regions of the BRCA 1 and BRCA 2 genes, although the CE mark denotes use of the test with Roche 454 sequencers. Mutations in these genes are associated with an increased risk of hereditary breast and ovarian cancer. Multiplicom will begin to ship the test throughout Europe beginning in September.

Multiplicom claims that the BRCA MASTR Dx test will “significantly” reduce the amount of validation labs need to perform prior to using the test in the clinical setting. As previously reported by PGx Reporter sister publication PCR Insider, Multiplicom believes that tests based on its MASTR (multiplex amplification of specific targets for resequencing) platform will be cheaper than existing sequencing methods (PCR Insider 6/7/2012).

The company said it has performed studies involving the BRCA MASTR Dx and Roche’s 454 sequencing instruments at several genetic centers in France and Belgium. The company will present data from these validation studies at a symposium ahead of the European Human Genetics Conference in Nurnberg, Germany on June 23.

Myriad Genetics is the market leader in genetic analysis of hereditary breast and ovarian cancer risk with its BRACAnalysis test, which combines PCR with Sanger sequencing. Although the company has an extensive IP suite around the BRACAnalysis test enabling it to be the only provider of BRCA testing for hereditary breast and ovarian cancer susceptibility, there is currently a lawsuit ongoing challenging Myriad’s patents on BRCA gene sequences and testing methods. The lawsuit has raised questions as to whether Myriad’s patents will protect the company against competition from advanced sequencing technologies.

Meanwhile, two years ago University of Washington’s Mary-Claire King and her colleagues described in a PNAS paper their method of using massively parallel sequencing to assess 21 genes, including BRCA1 and BRCA2, associated with heightened risk of breast and ovarian cancer.


Positive Phase III Results for PGx NSCLC Drug Xalkori, Pfizer Says

The first Phase III study involving Pfizer's Xalkori (crizotinib) has found the pharmacogenomically targeted non-small cell lung cancer drug to be superior to pemetrexed or docetaxel in patients with tumors that harbor ALK gene rearrangements.

In the PROFILE 1007 study, Xalkori "significantly improved" progression-free survival in previously treated ALK-positive patients with advanced NSCLC compared to pemetrexed or docetaxel. Researchers observed adverse events profiles for patients treated with Xalkori that were consistent with findings from earlier studies.

Pfizer will present detailed data from PROFILE 1007, the first Phase III study involving ALK-positive NSCLC patients, at an upcoming scientific meeting.

"These results are important because they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy in prolonging survival without progression in patients with previously-treated ALK-positive advanced NSCLC," Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer's oncology business unit, said in a statement.

The US Food and Drug Administration approved Xalkori last year on an expedited time frame based on results from two single-arm, Phase I trials involving 255 patients (PGx Reporter, 9/7/2011).

There are other trials investigating the safety and efficacy of Xalkori, including PROFILE 1014, which is a Phase III, open-label, two-arm study involving previously untreated ALK-postive advanced NSCLC patietns randomized to receive Xalkori or pemetrexed plus cisplatin or carboplatin. Additionally, PROFILE 1005 is a Phase II open-label, single-arm study looking at the efficacy and safety of Xalkori in patients with ALK-positive advanced NSCLC who have failed more than one line of prior chemotherapy.

The Scan

Back as Director

A court has reinstated Nicole Boivin as director of the Max Planck Institute for the Science of Human History, Science reports.

Research, But Implementation?

Francis Collins reflects on his years as the director of the US National Institutes of Health with NPR.

For the False Negatives

The Guardian writes that the UK Health Security Agency is considering legal action against the lab that reported thousands of false negative COVID-19 test results.

Genome Biology Papers Present Epigenetics Benchmarking Resource, Genomic Architecture Maps of Peanuts, More

In Genome Biology this week: DNA methylation data for seven reference cell lines, three-dimensional genome architecture maps of peanut lines, and more.