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MDx/CDx Focus: Study Data on Corus CAD; Clovis, Qiagen Partnership

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Researchers Investigate How Primary Care Docs use CardioDx's Corus CAD

When primary care physicians factor the results from CardioDx's Corus CAD into their treatment decisions, they can avoid unnecessary cardiac testing for patients deemed to be at low risk of obstructive coronary artery disease, data from a study suggests.

Researchers from CardioDx and elsewhere conducted a study, entitled REGISTRY I, in which they evaluated how primary care doctors at seven community practices used the Corus CAD test to make treatment decisions for 342 patients with non-acute typical and atypical symptoms. Patients with typical symptoms presented with chest pain, pressure, or heaviness in the neck, shoulder, jaw, back, or arm. Those with atypical symptoms had weakness, nausea, vomiting, or body aches.

Researchers found that each 10-point decrease in the Corus CAD score resulted in a 13-fold decrease in the likelihood that the doctors would refer their patients for additional cardiac testing. Patients with scores of 15 or lower by Corus CAD had a 94 percent decrease in the likelihood that doctors would refer them for further testing when compared to those with CorusCAD scores of greater than 15.

In the study cohort, "no major adverse cardiac events were noted at 30-days' follow-up," study investigators said. Researchers are presenting their findings from REGISTRY I at the Annual Meeting of the Society for Medical Decision Making this week in Baltimore, Md.

CardioDx believes that CorusCAD can help doctors rule out the risk of obstructive coronary disease in patients deemed to be at low risk by the test, and thereby save healthcare dollars by avoiding unnecessary testing. On a daily basis 8,000 patients with non-acute chest pain come into an outpatient clinic for treatment, but 9 out of 10 of these patients have symptoms unrelated to stable coronary artery disease. Additionally, each year in the US there are 6 million evaluations of acute chest pain, costing more than $3 billion.

Corus CAD gauges the expression level of 23 genes in peripheral blood that change depending on the amount of plaque on the walls of coronary arteries. The algorithm underlying the test factors in the expression of these genes, patients' age, and sex to yield a score between 1 and 40 that is associated with their risk of obstructive CAD. The higher a patient's Corus CAD score, the greater the risk that his or her chest pain is due to a blockage in the arteries of the heart. Corus CAD is specifically indicated for non-diabetic patients who have symptoms that suggest they may have obstructive CAD, but who have not been diagnosed with a heart attack or had invasive procedures to open a blocked artery.

The test has a negative predictive value of 96 percent and a sensitivity of 89 percent, according to CardioDx. List priced at $1,200, Corus CAD has Medicare coverage but most private payors are reimbursing for the test on a patient-by-patient basis (PGx Reporter 3/20/2013).


Clovis, Qiagen Partner to Accelerate NSCLC Drug Development with CDx

Clovis Oncology and Qiagen will work together to develop a companion test that identifies non-small cell lung cancer patients who harbor the T790M resistance mutation in clinical trials involving Clovis's investigational drug, CO-1686.

Qiagen will develop the T790M test based on the same platform as its Therascreen EGFR RGQ PCR Kit. That kit, gauging 29 EGFR mutations, was approved by the US Food and Drug Administration in July as a companion test that picks out best responders to Boehringer Ingelheim's NSCLC drug Gilotrif (PGx Reporter 7/17/2013).

Qiagen's EGFR test kit asses EGFR exon 19 deletions or exon 21 L858R substitutions. The kit includes four singleplex assays that gauge T790M, L858R, L861Q, and S768I mutations, and three multiplex assays that analyze a number of deletions, insertions, and G719X mutations.

Under the terms of the deal, Qiagen will be in charge of the global development and commercialization of the companion test, and Clovis will handle the global development and commercialization of CO-1686. Qiagen and Clovis didn't disclose additional terms of their agreement.

Clovis is currently investigating CO-1686 in Phase I/II dose escalation trials as a potential treatment for patients with EGFR mutated-tumors. The drug is an irreversible inhibitor of mutant EGFR. Clovis developed the agent specifically to target activating EGFR mutations driving the cancer and T790M resistance mutations, but leave intact normal EGFR.

T790M mutations, which occur in the epidermal growth factor receptor kinase, most commonly occur in patients' tumors after they have been treated with inhibitors of this kinase, such as Tarceva and Gilotrif, and have become resistant to therapy. Around half of lung cancer patients who acquire resistance to EGFR-inhibiting drugs are found to harbor T790M mutations in their tumors.

Clovis is planning to initially market CO-1686 as an option for those who have developed resistance to first-line EGFR inhibitors. Because of the mechanism of action underlying CO-1868, however, Clovis believes that the drug can be given to NSCLC patients with EGFR mutations as a first-line treatment as well. The company is also hoping that the drug will have a better toxicity profile than EGFR inhibitors currently on the market.

The fact that Qiagen already has FDA approval for its EGFR test as a companion diagnostic for another NSCLC drug, should hasten the CDx development program for CO1686, Clovis CEO Patrick Mahaffy said in a statement.

"Qiagen's test is already FDA approved to reliably and accurately detect EGFR mutations, including T790M, which complements our accelerated plan for CO-1686 clinical development by potentially allowing for a supplemental premarket approval filing," Mahaffy said.

CO-1686 and Qiagen's T790M test will be developed in parallel so that the drug and companion test can be approved at the same time. Clovis will use the EGFR test to stratify patients in its Phase II expansion cohorts, slated for enrollment at the end of the year.

In addition to the deal around CO-1686, Qiagen and Clovis have inked a non-exclusive, master collaboration agreement that will allow Clovis to use Qiagen's test platform to personalize other drugs in its pipeline.

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