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MDx/CDx Focus: MolecularMD Grabs LKB1 Rights; Clarient Offering Qiagen KRAS Test; Inform's OnPART

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MolecularMD Gains Exclusive IP Rights to Develop LKB1 Genetic Tests for NSCLC

MolecularMD has garnered the exclusive right to use the patents on LKB1 mutations to launch genetic tests for non-small cell lung cancer.

According to a statement from MolecularMD, the LKB1 patents are jointly held by the Dana-Farber Cancer Institute, the Massachusetts General Hospital, the University of North Carolina at Chapel Hill, and the University of Texas Southwestern Medical Center. "Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to use of LKB1 for diagnostic, prognostic and predictive uses in humans in the area of NSCLC," the company added.

LKBI is a tumor suppressor gene that is mutated in 20 percent to 30 percent of NSCLC and is commonly found in smokers and alongside variations in other cancer genes, such as TP53, PIK3CA, MYC, CDKN2A, and KRAS. However, LKB1 mutations don't occur with EGFR mutations. Furthermore, loss of the LKB1 protein is linked to cancer aggressiveness, especially if the patient also has KRAS mutations.

MolecularMD believes that testing for LKB1 mutations may be critical to predicting whether patients will respond to targeted treatments and chemotherapy agents. Clinical data suggests that LKB1 mutations may predict non-responders to MEK and PI3K pathway inhibitors in lung cancer.

The company said it is developing immunohistochemistry and next-generation sequencing-based LKB1 tests. "Tumor suppressors play a critical role in determining responsiveness to therapies targeting oncogenes. MolecularMD's offering of both LKB1 IHC and NGS assays will provide critical additional information to predict responsiveness to both targeted agents and chemotherapy especially in the context of MEK inhibitors in KRAS mutant lung adenocarcinoma," Sabita Sarkar, MolecularMD's scientific affairs liaison, said in a statement.

The company said that it is willing to sublicense the LKB1 technology to other reference labs and test developers to drive further commercialization of the test.

MolecularMD in 2010 licensed patent rights from New York University and Memorial Sloan-Kettering Cancer Center covering technology that will enable the development of a BRAF mutation test to personalize treatment for patients with melanoma and other cancers.


Clarient Offering Qiagen's Therascreen KRAS Test in the US

GE Healthcare subsidiary Clarient will offer testing with Qiagen's Therascreen KRAS RGQ PCR Kit as a companion diagnostic to gauge who should receive the metastatic colorectal cancer drug Erbitux.

By carrying the test in its test menu, Qiagen's test becomes available to Clarient's customer base of more than 2,000 pathologists, oncologists, clinical labs, and hospitals.

The US Food and Drug Administration last year approved a new indication for Bristol-Myers Squibb/Eli Lilly's Erbitux (cetuximab) in combination with a chemotherapy regimen as a first-line treatment in patients with metastatic colorectal cancer who have EGFR-expressing, KRAS wild-type tumors. Simultaneously, the agency also approved Qiagen's KRAS test to pick out best responders to the drug (PGx Reporter 7/11/2012).

According to Qiagen, the US launch of the KRAS companion test "is progressing well." For labs that add the test to their test menus, Qiagen provides co-marketing services, reimbursement support, on-site validation, and healthcare provider education. According to Qiagen, there are 12 labs including Clarient that currently offer the Therascreen KRAS companion test for Erbitux.


Early Data Suggests Inform Genomics' OnPART May Predict Chemo-Related Side Effects

Inform Genomics presented data at a scientific conference that its OnPART genomic test can assess whether patients are likely to experience serious side effects from chemotherapy regimens.

At the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in San Francisco this week, researchers from Inform Genomics and the West Clinic in Memphis presented data from an early phase study enrolling 384 patients.

The preliminary data suggest OnPart may be a tool that doctors can use to identify which patients are at risk for six common, chemotherapy-related side effects.

The study enrolled patients with breast, colorectal, lung, and ovarian cancer, who had been treated with standard chemotherapy regimens including dose-dense doxorubicin, cyclophosphamide and paclitaxel for breast cancer; 5-fluoururacil and oxaliplatin based regimens for colorectal cancer; and carboplatin plus paclitaxel based regimens for lung and ovarian cancer.

Researchers followed patients for a minimum of three cycles of chemotherapy and reported six treatment-related side effects, including oral mucositis, nausea and vomiting, diarrhea, fatigue, cognitive dysfunction, and peripheral neuropathy. They then collected patients' saliva and analyzed the samples for genomic markers linked to the side effects.

At the meeting, the firm reported data from 57 colorectal cancer patients who had received a modified chemo regimen containing 5-flourouracil, folinic acid, and oxaliplatin with or without bevacizumab. "Using algorithms based on Bayesian methodological programming, predictive networks were discovered for each of 6 chemotherapy-induced side effects with accuracies greater than 90 percent," Inform Genomics reported in a statement.

The researchers found that the test was able to predict which patients experienced oral mucositis with 100 percent accuracy; nausea and vomiting with nearly 95 percent accuracy; diarrhea with 100 percent accuracy; fatigue with 98 percent accuracy; cognitive dysfunction with 98 percent accuracy; and peripheral neuropathy with 96 percent accuracy.

Inform Genomics CEO Ed Rubenstein said that following this data, the company plans to conduct a multicenter, prospective trial to evaluate OnPART. That study is slated to launch later this year.

Rubenstein previously told PGx Reporter that the OnPART test analyzes not just the genomic risk for chemo-related side effects, but also includes a way to quantify how patients view these side effects (PGx Reporter 10/10/2012).

The Scan

CDC Calls Delta "Variant of Concern"

CNN reports the US Centers for Disease Control and Prevention now considers the Delta variant of SARS-CoV-2 to be a "variant of concern."

From FDA to Venture Capital

Former FDA Commissioner Stephen Hahn is taking a position at a venture capital firm, leading some ethicists to raise eyebrows, according to the Washington Post.

Consent Questions

Nature News writes that there are questions whether informed consent was obtained for some submissions to a database of Y-chromosome profiles.

Cell Studies on Multimodal Single-Cell Analysis, Coronaviruses in Bats, Urban Microbiomes

In Cell this week: approach to analyze multimodal single-cell genomic data, analysis of bat coronaviruses, and more.