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MDx/CDx Focus: CardioDx's Corus CAD in Heart Study; EMA Filing for Vintafolide; Transrenal KRAS Test

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CardioDx to Assess Corus CAD as Part of PROMISE Study

CardioDx announced this week that it will use its Corus CAD molecular diagnostic to analyze samples from as many as 3,000 non-diabetic patients enrolled in a randomized trial comparing the efficacy of diagnostic strategies to gauge which stable patients suspected of having coronary artery disease actually have the condition.

The Prospective Multicenter Imaging Study for Evaluation of Chest Pain, or PROMISE, will compare the effectiveness of anatomic imaging versus non-invasive diagnostic tests, such as exercise electrocardiogram, stress echocardiography, or myocardial perfusion imaging.

As part of the study, researchers will also collect genomic samples from between 2,500 and 3,000 patients. CardioDx will analyze these samples with Corus CAD and analyze whether the test can predict whether patients will experience major cardiovascular events.

Corus CAD gauges the expression of mRNA by 23 genes via real-time PCR to help physicians exclude obstructive coronary artery disease as the cause of cardiac symptoms in stable non-diabetic patients.

PROMISE, sponsored by Duke University in collaboration with the National Heart, Lung, and Blood Institute, plans to enroll 10,000 patients who are stable but are suspected of having CAD and have been referred by their doctors for non-invasive diagnostic testing for CAD. Researchers plan to follow patients enrolled in PROMISE for up to four years or until the study ends. Investigators will follow patients for major adverse cardiac events and assess the costs and safety of the various testing methods.

As a participant in PROMISE, CardioDx will "evaluate the use of Corus CAD as an aid in the prognosis of clinical events," CEO David Levison said in a statement. "This study will allow us to build on the results of the Corus CAD test as an aid in the assessment of CAD, as demonstrated in the PREDICT and COMPASS validation studies."

CardioDx may also use the findings from PROMISE to guide its development of a CAD prognostic test based on next-generation sequencing technologies that can assess whether patients express genes that place them at risk of future cardiac events, Levison added.

According to CardioDx, clinicians have used Corus CAD in more than 31,000 patients and the test is a covered benefit for more than 40 million Medicare beneficiaries in the US. The lab-developed test was launched in 2009.


EMA Accepts Application for Vintafolide, Companion Imaging Dx for Hard to Treat Ovarian Cancer

The European Medicines Agency has accepted for review Merck and Endocyte's marketing authorization application for vintafolide in combination with pegylated liposomal doxorubicin and a companion diagnostic imaging agent.

Vintafolide – which combines the vitamin B9 folate and the chemotherapy agent desacetylvinblastine monohydrazide – is an investigational treatment for folate-receptor positive, platinum-resistant ovarian cancer. The drug is designed to target cancer cells that overexpress folate receptors. In clinical trials, researchers injected patients with the folate-targeting imaging agent, etarfolatide, to gauge whether they have tumors overexpressing folate receptors and will therefore respond to vintafolide.

The latest regulatory filings by Merck and Endocyte are supported by four clinical studies: a Phase I study in solid tumors, two single-arm Phase II studies looking at vintafolide as a single agent in ovarian cancer and non-small cell lung cancer, and the PRECEDENT trial, a randomized Phase IIb study in patients with platinum-resistant ovarian cancer. The sponsors have submitted for conditional approval if the Phase II studies prove vintafolide fulfills an unmet medical need.

Vintafolide is currently being evaluated in a Phase III randomized clinical trial in folate-receptor positive, platinum-resistant ovarian cancer patients. That trial, called PROCEED, is investigating vintafolide in combination with pegylated liposomal doxorubicin compared to PLD plus placebo for the treatment of folate-receptor positive platinum-resistant ovarian cancer. This trial, which is also using etarfolatide to identify patients with over-expressing folate receptors, will measure progression-free survival and overall survival.

Under the terms of their deal, Merck will pay Endocyte a $5 million milestone payment for the EMA filing acceptance for the drug and companion test. Merck is responsible for developing the drug and commercializing it globally. Endocyte will copromote the drug in the US, but is responsible for selling, manufacturing, and developing etarfolatide worldwide.

The European commission has granted vintafolide and etarfolatide orphan status. This year, there will be more than 40,000 new cases of ovarian cancer in the EU. Around 80 percent of these patients relapse after receiving platinum-based chemotherapy in the first-line setting, and around 80 percent of patients with platinum-resistant ovarian cancer have folate-receptor positive disease.


Trovagene Plans 2013 Launch for First Test to Detect KRAS Mutations in Urine

Trovagene this week announced it has developed a molecular diagnostic that can detect KRAS mutations in patients' urine. The company plans to begin marketing the transrenal KRAS test through its CLIA lab in January 2013.

"Our scientific team has developed the first commercially viable process for quantitative detection of KRAS mutations in transrenal DNA isolated from a simple urine specimen," Charlie Rodi, chief technology officer of Trovagene, said in a statement. "This represents a breakthrough in cancer monitoring, and will provide oncologists and surgeons with the ability to frequently check mutation status before, during, and after therapy."

Qiagen markets a KRAS companion test for the metastatic colorectal cancer drug Erbitux that the US Food and Drug Administration approved in July. That test analyzes KRAS mutations linked to limited drug response in paraffin-embedded tumor tissue samples.

According to Trovagene, cell-free nucleic acids, found in both normal and cancer cells, circulate in the bloodstream, pass the kidney barrier, and can be found in urine as transrenal DNA. The company estimates that approximately 360,000 newly diagnosed cancer patients in the US have KRAS mutation-positive disease.

In addition to the KRAS test, Trovagene is planning to also launch transrenal tests that detect BRAF and PIK3CA mutations. These non-invasive tests, Trovagene is hoping, will be used to monitor disease recurrence, predict treatment response, and detect disease.

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.