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CAP Today




July 2012

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Transgenomic launches gene test technology

Transgenomic launched last month its Ice Cold-PCR DNA mutation detection technology, which enables enrichment and detection of mutation frequencies as low as 0.01 percent using standard PCR and sequencing equipment. Available now is an Ice Cold-PCR kit for enrichment of KRAS mutations.

“This is an enrichment technology that runs on standard PCR equipment,” Transgenomic CEO Craig Tuttle told CAP TODAY. “So, if you’re doing PCR in your lab today—as 40,000 labs are—you can run Ice Cold and enrich for mutations 1,000- to 10,000-fold, and then, therefore, find them even if they are at very low levels.”

Because it is extremely sensitive, Ice Cold technology enables mutations to be detected in virtually any sample type, including tissue biopsies, blood, and circulating tumor cells. Mutation profiling from blood and CTCs may benefit cancer patients because it can help prevent additional surgical procedures, while providing an up-to-date picture of additional mutations the cancer may have acquired throughout patient treatment.

Tuttle said in a statement that Ice Cold-PCR offers the ability to perform safer, less invasive, and more frequent assessments of a cancer and its mutations through a simple blood draw. “Our first objective with the technology is to look at monitoring patients under treatment to look at their mutation profile, and hopefully see that mutation disappear when treatment is effective,” he told CAP TODAY.

The company developed Ice Cold-PCR in collaboration with the Dana-Farber Cancer Institute. The technology is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity—up to 1,000 times more sensitive than traditional PCR. The technology, launched at this year’s ASCO annual meeting, is also being evaluated in a study with the University of Texas MD Anderson Cancer Center to analyze DNA isolated from CTCs.

Transgenomic plans to expand its Ice Cold-PCR testing platform to include BRAF, EGFR, and PIK3CA mutations. “We see the emergence of this technology as a very viable mechanism to run in our laboratory or sell as a kit in front of Sanger sequencing or next-generation sequencing,” Tuttle says.

With pertuzumab, more time for breast cancer patients

The combination of pertuzumab, trastuzumab, and chemotherapy in patients with HER2-positive metastatic breast cancer has been shown to extend progression-free survival by a median of 6.1 months.

The FDA on June 8 approved Genentech’s Perjeta (pertuzumab) in combination with the company’s Herceptin (trastuzumab) and docetaxel chemotherapy to treat people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.

The approval is based on results from CLEOPATRA, an international phase three study of pertuzumab and trastuzumab. Data from the study showed that people with previously untreated HER2-positive metastatic breast cancer who received Perjeta and Herceptin and docetaxel chemotherapy had a median progression-free survival of 18.5 months. Those who received only Herceptin plus docetaxel chemotherapy and placebo had a median PFS of 12.4 months.

Genentech has agreed to post-marketing commitments, related to the manufacturing process for Perjeta, that include FDA review of data from the next several productions of the medicine.

Genentech’s parent company, Roche, has submitted to the European Medicines Agency a marketing authorization application for Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of HER2-positive metastatic or locally recurrent, inoperable breast cancer in those who have not been treated previously or whose disease has returned after treatment in the early-stage setting.

Clarient licenses ALK biomarker from Insight

Clarient Diagnostic Services and Insight Genetics announced a worldwide licensing agreement for intellectual property from Insight that grants Clarient rights to develop a genetic test covering the anaplastic lymphoma kinase (ALK) biomarker.

As a result of the deal, Clarient intends to develop and evaluate the performance characteristics of a quantitative PCR-based test that detects increased transcription of the ALK gene, rearrangements of which are implicated in non-small cell lung cancer and other cancers. Several ALK inhibitors are in clinical trials. One, Xalkori, is FDA approved.

“The National Comprehensive Cancer Network guidelines now suggest ALK testing as a standard measure for all non-small cell lung cancer patients due to the development of therapies targeting ALK inhibition,” Clarient chief medical officer Kenneth J. Bloom, MD, said in a statement. He called the agreement an example of Clarient’s “mission of translating biomarker discovery to aid the development of new therapeutics and to assist physicians in determining the eligibility of their patients to receive the most appropriate therapy.”

Melanoma signatures at center of HTG, JWCI union

The John Wayne Cancer Institute at Saint John’s Health Center in Santa Monica, Calif., selected as a commercialization partner HTG Molecular Diagnostics, which recently identified melanoma signature assays that may have diagnostic and prognostic applications.

In a multi-year collaboration with John Wayne Cancer Institute, HTG developed research assays and analyzed more than 400 annotated cases of melanoma, from benign nevus to metastatic disease, resulting in several signatures.

“This partnership will be the embodiment of the clinical application of molecular gene expression to which HTG Molecular Diagnostics dedicates our resources in our mission to improve patient care and ultimately help save lives,” HTG CEO TJ Johnson said in a statement.

Dave S. Hoon, MSc, PhD, chief of scientific intelligence at John Wayne Cancer Institute, said in a statement that HTG’s advantages in working with archival paraffin-embedded tissues enabled discovery of the signatures and called the agreement “an exciting and critical next step in the process of applying translational molecular oncology to the detection and treatment of melanoma.”