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MDx/CDx Focus: AssureRx Launches ADHD PGx Test; Adcetris Phase III Study in CD-30 Lymphoma; CardioDx

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AssureRx Launches GeneSightRx ADHD

AssureRx Health this week launched a pharmacogenetic test, called GeneSightRx ADHD, for characterizing patients' response to a variety of attention deficit hyperactivity disorder drugs.

The test analyzes variations in three genes, which were selected based on information in the scientific literature and drug labels, and "may help a clinician individualize a patient's medication selection and avoid side effects that often occur with these medications," the company said in a statement.

Doctors can take a cheek swab and send in the sample for analysis in AssureRx's CLIA-certified lab. Test results are sent to the doctor via a secure online portal.

ADHD is the most common childhood disorder, according to AssureRx, which cited a study published last month in Academic Pediatrics that estimated that diagnoses of the disorder increased from 6.2 million in 2000 to 10.4 million in 2010. Symptoms of ADHD, which includes an inability to stay focused and hyperactivity, can progress on to adulthood.

In addition to the ADHD PGx test, AssureRx also markets GeneSightRx Psychotropic, another diagnostic that gauges genomic variants associated with patients' ability to metabolize certain psychiatric medications.


Millennium, Seattle Genetics Launch Pivotal Study for Adcetris in CD30-Expressing T-Cell Lymphoma

Millennium and Seattle Genetics have launched a Phase III study evaluating the drug Adcetris in previously treated patients with CD30-expressing cutaneous T-cell lymphoma.

Millennium, the oncology subsidiary of Takeda Pharmaceutical, is developing Adcetris in collaboration with Seattle Genetics. Adcetris is an antibody-drug conjugate that is directed at CD30, a cell membrane protein of the tumor necrosis factor family.

The randomized, open-label Phase III study is comparing Adcetris against the investigator's choice of methotrexate or bexarotene in approximately 124 patients with CD30-positive CTCL. The primary study endpoint is overall response rate lasting at least four months, with Adcetris in patients with CD30-positive CTCL compared to the ORR achieved by patients in the control arm. Secondary endpoints include complete response, progression-free survival, and burden of symptoms.

The study involves the evaluation of a companion test to identify patients with CD30-expressing malignancies. Millennium and Seattle Genetics have inked a deal with Ventana to develop the molecular companion diagnostic test accompanying Adcetris.

Data from published literature suggest that as much as 50 percent of CTCL lesions express CD30.

The Phase III trial design was established under a Special Protocol Assessment agreement with the US Food and Drug Administration and with advice from the European Medicines Agency, Millennium and Seattle Genetics said in a statement. The study will be conducted at sites in the US, Europe, Australia, and Brazil.

If successful, the clinical trials for Adcetris in CTCL will provide guidance on Millennium/Seattle Genetics' broader program to study the drug in other CD30-expressing malignancies, such as Hodgkin lymphoma and mature T-Cell lymphomas. The Phase III studies for these indications are slated to begin in 2012 and 2013, respectively.


CardioDx to Present Clinical Utility Data on Corus CAD Gene Expression Test

At upcoming conferences, CardioDx is planning to present data from two studies evaluating how its Corus CAD gene expression test impacts clinician decision-making for patients with suspected obstructive coronary artery disease.

John McPherson of Vanderbilt University will present data from the IMPACT trial at the Quality of Care and Outcomes Research 2012 Scientific Sessions on May 9 in Atlanta.

IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) investigated the effect of Corus CAD test scores on clinical decision-making for stable patients who had been referred to cardiologists for evaluation of chest pain and related symptoms suggesting they possibly had obstructive coronary artery disease.

The study enrolled 83 nondiabetic patients referred to Vanderbilt University Medical Center cardiologists. In the study, investigators compared the cardiologists' diagnostic strategies before and after the Corus CAD score was known.

In addition, Michael Conlin of Johns Creek Primary Care in Suwanee, Ga., will present data from a study at the Society of General Internal Medicine's annual meeting in Orlando, Fla., on May 11.

This study looked at the effect of the Corus CAD test at four community-based primary care clinics in Arizona, Georgia, Louisiana, and North Carolina. There were 317 patients enrolled in the trial. Study investigators assessed how test scores less than or equal to 15, or low scores, and test scores higher than 15, or non-low scores, are used by primary care providers to guide their decision to refer stable patients they think might be at risk for coronary artery disease.

Additionally, study investigators compared how doctors used noninvasive and invasive cardiac tests in patients with low Corus CAD scores versus those with non-low scores.

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