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Old 09-29-2010, 05:50 PM
Dross Dross is offline
Join Date: Nov 2006
Posts: 883
Default Screening tool can detect colorectal cancer from a small blood sample

DENVER — A new microRNA (miRNA) screening assay detected the majority of early-stage colorectal cancers with good specificity and sensitivity.

"Our test has the potential to be safe, cheap, robust, accurate and of little or no inconvenience to the individual, and could, therefore, easily be integrated into national screening programs as part of an annual checkup," said Søren Jensby Nielsen, Ph.D., scientific manager, Diagnostic Product Development, Exiqon A/S.

Nielsen presented the results at the Fourth AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development, held here.

"We envision that this type of miRNA profile, once developed and marketed as a screening kit, can be used to screen entire populations in order to facilitate a focused selection of individuals who should undergo colonoscopy," Nielsen said.

Colorectal cancer is the second leading cause of cancer-related deaths in the western world. If diagnosed early, the disease can usually be cured with surgery; however, the prognosis for late-stage cancer is grim. Although several early-detection screening methods are available, "current estimates suggest that less than half of Americans over the age of 50 receive adequate colorectal cancer screening," Nielsen said.

Nielsen's team developed a state of the art screening method based on the miRCURY LNA™ Universal RT microRNA PCR. With it, they profiled blood plasma samples collected from patients with early, resectable (Stage II) colorectal cancer and sex- and age-matched healthy volunteers.

The findings suggested that it is possible to distinguish early-stage colorectal cancer from healthy subjects with good sensitivity and specificity from a single plasma sample — less than 1 mL of blood. Nielsen and colleagues are starting a large, prospective clinical trial in symptomatic individuals undergoing colonoscopy to prospectively validate their screening test.

Although Nielsen's team focused on colorectal cancer screening, their results indicated the technology has broader applicability. They have used the technology in a project to detect early stage colorectal cancer patients who are likely to experience disease recurrence and, therefore, are candidates for more aggressive adjuvant chemotherapy.

Last edited by gdpawel : 01-31-2012 at 09:29 PM. Reason: post full article
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Old 12-23-2010, 05:04 AM
johnmite123 johnmite123 is offline
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Default Re:

I agree with you that the views are impressive but you have to explore more.....

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Old 12-23-2010, 01:22 PM
gdpawel gdpawel is offline
Join Date: Feb 2007
Location: Pennsylvania
Posts: 4,360
Default Erroneous Assumptions

Oncotech, Inc. was a clinical laboratory in southern California for twenty-five years. The operation of which was subject to very strict operating criteria. Little questions involved patient records, HIPPA regulation as well as the company's rather extensive tumor bank; a treasure trove of personal DNA samples not to mention substantial biohazard waste if the decision to dispose of the material is reached.

Given the lack of thoughtfulness to this point I'd not be surprised to find this to be Exiqon's chosen path to acquire Oncotech. Some are convinced that Exiqon acquired Oncotech under the apparently erroneous assumption that by owning a clinical laboratory in the United States it could easily bring its Danish products to market in the USA. Oncotech was acquired by Exiqon in November 2007 to set up a commercial platform for the launch of its miRNA-based diagnostics products.

Shortly after its acquisition, Exiqon, with the treasure trove of personal DNA samples in its vault, closed the doors on Oncotech. Then Exiqon signed a development and distribution deal with MultiD Analyses to adapt MultiD's GenEx qPCR analysis software for Exiqon's new microRNA qPCR platform. The deal allows it to sell a fully compatible and comprehensive miRNA qPCR data-analysis solution.

The partnership between the companies resulted in a customized version of GenEx, which had been specifically adapted to allow pre-processing and analysis of data from the Exiqon microRNA PCR panels and assays.
Gregory D. Pawelski
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Old 01-31-2012, 09:34 PM
gdpawel gdpawel is offline
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Location: Pennsylvania
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Default Exiqon subsidiary Oncotech goes out of business — irresponsibly

By Dr. Larry Weisenthal 12-June-2010

Oncotech is — or was — an American laboratory providing individualized tumor response testing (ITRT) as a service to patients and physicians since the mid-1980s. It was co-founded by Robert Nagourney and I. We each left the company in the early 1990s, over disagreements with the controlling investors (4 venture capital companies) over the management and directions of the company. I remained supportive of the company, over the years, and played an important role in securing and, later, retaining reimbursement by Medicare for their services. Robert and I each started our own small private laboratories to offer related cell culture testing services.

Oncotech continued operations as a privately-held, venture-capital controlled company until February of 2008, when it was acquired (purchased) by a Danish biotechnology company called Exiqon, Inc. for $45 million (US) in Exiqon securities.

Exiqon replaced the Oncotech CEO and installed its own management team, continuing to operate Oncotech as a wholly-owned subsidiary, with a business model centered around providing ITRT on a (US) national basis — importantly to Medicare patients.

In the case of my own laboratory, we opted out of Medicare, effective July 1. 2008, because the reimbursements received from Medicare did not cover our costs of providing our services.

Exiqon Oncotech, however, depended on Medicare reimbursement to support its business model. In the USA, Medicare coverage decisions for many types of medical services are made at the regional level, by the private insurance companies with which Medicare contracts to administer services to Medicare beneficiaries (most prominently, patients 65 years of age and older). Previous Medicare contractors for California made the determination that ITRT qualified as a Medicare covered service. These included the TransAmerica and National Heritage Insurance companies. Most recently, an insurance company called Palmetto was awarded the contract to administer Medicare services for California. Palmetto made the decision to discontinue Medicare payment for ITRT in California.

Last week, Exiqon Oncotech announced that it was discontinuing operations, because of the withdrawal of Medicare reimbursement for its services. This was an entirely understandable, if regrettable, decision. What was in no way understandable — or defendable, for that matter — was the way that they ceased operations.

Exiqon Oncotech sent out notifications to its client physicians that it was ceasing operations, virtually immediately. On a single day this past week, they received two dozen specimens from human tumor biopsies via FedEx and other couriers. All of these specimens were simply sent back to the hospitals and clinics which sent the specimens. Physicians were told that there were no other laboratories who could perform the tests requested.

While it is true that no other American laboratories have chosen to utilize Exiqon Oncotech’s non-proprietary technology for ITRT, it was well known to Exiqon Oncotech that there are a number of highly experienced, well qualified, well-published American laboratories which provide this service, utilizing different, but at least comparably valid, technologies.

In my long experience in this field, I well remember two previous, investor-backed, clinical laboratory companies which provided ITRT as a service to patients, only to make the decision that their business models were no longer viable. These companies were (1) Analytical Biosystems and (2) NuOncology Laboratories. When these latter companies ceased operations they (a) did so in an orderly fashion, giving their clients adequate advance warning and winding down operations at a pace which enabled them to provide testing for those patients and physicians who had already planned and depended upon receiving these services, and (b) these companies were open and helpful in providing their former client physicians with contact information for other laboratories within the US which continued to provide ITRT services.

In the case of Exiqon Oncotech’s two dozen tumor specimens simply marked “return to sender,” I can scarcely imagine anything more irresponsible. In many of those cases, doubtless the physicians and/or surgeons discussed in advance with their patients the importance of sending their biopsies for ITRT. In some cases, the surgical procedure may have been performed primarily for the purpose of ITRT. In other cases, the patients were doubtless comforted by knowing that this testing was to be performed.

Business is business, but, at a certain point, business is also about people, and cancer business is, or should be, about cancer patients.

I am saddened by the shuttering of Oncotech’s doors, 25 years after its founding, and I am ashamed at the way in which those doors were apparently shuttered.

It should be noted that the Medicare contractor for the state of Pennsylvania continues to provide coverage for ITRT and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provides ITRT and accepts Medicare reimbursement as payment in full. California laboratories continuing to provide ITRT (without Medicare reimbursement, possibly requiring patient payment for services) include Rational Therapeutics, Anticancer, Inc., and my own laboratory.

Follow-up: an earlier blogpost by an Exiqon Oncotech employee provides independent confirmation of the above.

Gregory D. Pawelski
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