College of American Pathologists
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CAP Today




August 2011

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First clinical practice study reported for EarlyCDT-Lung

A 1,010-patient study of the Early-CDT-Lung serum assay (Oncimmune) found a sensitivity for non-small cell lung cancer at least as high as in the previously published validation studies, including for early-stage disease. Lung cancer expert James Jett, MD, professor of medicine at National Jewish Health, Denver, presented the results July 7 in Amsterdam at the World Conference on Lung Cancer.

“Data auditing the use of the test in clinical practice are consistent with the case-controlling studies. These data indicate that the Early-CDT-Lung test can risk-stratify normal versus malignant nodules,” Dr. Jett said in a statement. The current Fleischner guidelines that pulmonologists use for risk stratification and to guide the monitoring of CT nodules, he said, “are not as precise as we would like, and any tool that allows us to further risk-stratify these nodules is of value.”

The 1,010-patient audit, which began in May 2009, included results from EarlyCDT-Lung’s initial six-antigen panel and the current seven-antigen panel that enables greater than 90 percent accuracy. EarlyCDT-Lung has 93 percent specificity. The 1,010 patients in North America at high risk for lung cancer, on the basis of age and smoking history, came from 293 centers across 40 states.

John Robertson, MD, FRCS, chief scientific officer and founder of Oncimmune and professor of surgery, City Hospital, University of Nottingham, United Kingdom, said in the statement, “Collective data published in the Annals of Oncology, Clinical Cancer Research, and an in-press manuscript with Cancer Prevention Research continue to demonstrate the depth of our scientific data and its reproducible performance.”

The abstract is at See CAP TODAY, August 2010, for more on EarlyCDT-Lung.

Sequenom signs for HiSeq

Sequenom has signed a three-year supply agreement with Illumina for its HiSeq 2000 platform. Under terms of the deal, Sequenom and its subsidiaries will purchase Illumina’s sequencing equipment and consumables for use in developing a noninvasive test for an overabundance of chromosome 21 in pregnant women, which is associated with fetal Down syndrome.

Sequenom and Illumina will work collaboratively toward the submission for regulatory approval of an in vitro diagnostic product for detecting fetal chromosomal abnormalities.

Harry F. Hixson Jr., chairman and CEO of Sequenom, said in a statement, “This agreement is an important step in bringing our proprietary trisomy test to market, giving us the scalability, speed to market, and supply chain necessary to address the commercial opportunity of our noninvasive prenatal test for trisomy 21.”

Personalized medicine on a broader scale

The Kew Group, a personalized oncology company, and the Cancer Clinics of Excellence clinical network are taking steps to improve cancer care by bringing personalized medicine to community cancer clinics.

Kew’s aim is to provide community oncology clinics throughout the U.S. with the information and tools needed to diagnose and treat patients with the same level of care now associated with academic specialty centers. Kew and Cancer Clinics of Excellence founders are leaders in academic and community oncology practice, information technology, and personalized medicine.

“Our goal is providing patients in their local communities with the quality of diagnosis and clinical care that a patient at a leading academic comprehensive cancer care center would have,” says Jeff Elton, PhD, co-founder and CEO of Kew Group, Concord, Mass. “We’re building the required infrastructure and partnerships to ensure that outstanding cancer care is delivered rapidly, precisely, and efficiently at the community level.” To this end, Kew is merging its clinical informatics and molecular diagnostics businesses with that of the Cancer Clinics of Excellence, a network of 21 oncology practices in 14 states that provides care to patients in their own communities.

Kew now partners and is contracting with regional molecular diagnostic laboratories and will broaden its partnerships with community pathologists, Dr. Elton told CAP TODAY. “While we will have our own diagnostic labs and national partnerships to acquire specialized capabilities required by our business model, we’re not going to be doing the full range of things. Because of where our patients originate, and the very positive relationships our practices have with local pathology groups, we plan for strong relationships with specific local pathology practices. Ultimately, we will be linking the oncologists and pathologists in those communities in a variety of different beneficial relationships.”

Kew and Cancer Clinics of Excellence are assembling a set of evidence-based, “genetically informed,” clinical pathways for patient diagnosis, treatment selection, response monitoring, and post-treatment followup, Dr. Elton says. They have about 70 clinical pathways now that cover most of the major cancers and another 15 in the pipeline. “We have an electronic infrastructure that allows us to extract data out of electronic medical record formats and put it into a central clinical data repository, and then we can assess whether patients are being treated according to the pathways,” he says.

In addition to stratifying patients into clinical pathways, Kew and CCE identify the clinical trials for which the patients might be eligible. “What we’re trying to do,” Dr. Elton says, “is find as many appropriate treatment options as possible for physicians and their patients.”

Competing with academic centers is not what Kew is about, he says, adding, “We cooperate with and depend on them. We have academic founders and advisors in all areas.” How best to describe Kew and CCE? “We’re a practical and population-scale realization of personalized medicine for community oncologists and their patients.”

FDA proposes new policy for some IVD, radiology devices

The FDA on July 7 issued a draft guidance describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.

The draft guidance, which is open for comment for 90 days, lists 30 different device types, including common urine and blood tests, alcohol breath tests, blood-clotting protein tests, and radiology device accessories. The FDA intends to exempt these devices from premarket notification requirements through the appropriate regulatory processes. In the meantime, however, the FDA does not intend to enforce the premarket notification requirements with respect to these devices provided they do not exceed the limitations on exemption specified in the device classification regulations.

The FDA intends to continue to enforce all other applicable requirements, including, but not limited to, registration and listing and Good Manufacturing Practices as set forth in the Quality System regulations.

The device types listed in the draft guidance include devices identified by the FDA as those for which less stringent oversight would not compromise public health. In the future, the FDA intends to reduce the premarket regulatory burden on additional in vitro diagnostic and radiology device types.

Qiagen buy underway

The settlement-delivery of Qiagen’s acquisition of about 62.5 percent of the share capital of Ipsogen was completed last month. Qiagen will file a public offer on the balance of shares of capital stock of Ipsogen at a price of 12.90 euros per share.

Acquiring Ipsogen provides Qiagen access to a range of assays covering 15 biomarkers for hematological cancers. Most of Ipsogen’s assays have CE-IVD marking in Europe and can be used on Qiagen’s Rotor-Gene Q real-time PCR system, which enables them to be transferred onto the company’s QiaSymphony RGQ laboratory automation platform.

The approximately 80 tests Ipsogen offers are divided into four assay families: BCR-ABL (chronic myeloid leukemia), JAK2 V617F (myeloproliferative diseases), PML-RARA (promyelocytic leukemia), and a group of several products for use with a range of rare forms of leukemia.

Ipsogen also is developing the Genomic Grade multigene expression test that seeks to address unmet diagnostic needs for women with early invasive hormone-receptor–positive breast cancer.

Upon completion of the offer, Ipsogen’s site in Marseilles, France, is expected to become a global center of excellence within Qiagen focused on leukemia and breast cancer and a center for developing and manufacturing other molecular tests.