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Data Presented at the Annual Meeting of the American Association of Endocrine Surgeons Illustrates the Clinical Utility of miRInform® Thyroid Panel Used in Conjunction with Ultrasound-Guided Fine Needle Aspiration
[May 01, 2012]

Data Presented at the Annual Meeting of the American Association of Endocrine Surgeons Illustrates the Clinical Utility of miRInform® Thyroid Panel Used in Conjunction with Ultrasound-Guided Fine Needle Aspiration

AUSTIN, Texas --(Business Wire)--

Asuragen, Inc. announced today that data related to its miRInform® Thyroid Panel was recently presented at the 33rd Annual Meeting of the American Association of Endocrine Surgeons in Iowa City, Iowa.

Dr. Alexander Shifrin, an Endocrine Surgeon from Jersey Shore University Medical Center, presented a poster entitled "Use of molecular markers on FNA biopsies of thyroid nodules, as recommended by recent ATA guidelines, modifies surgical treatment of thyroid nodules and thyroid cancer." The poster describes the results of his recent independent evaluation of the miRInform® Thyroid Panel and its impact on improving the surgical management and treatment of patients with suspicious or positive thyroid FNA cytology.

Dr. Shifrin, et al, collected data from 54 potential surgical patients of which 49 underwent surgery and 5 were canceled based upon mutation-negative FLUS/AUS (follicular lesion of undetermined significance/atypia of undetermined significance) status. The surgical approach was changed in 11 patients (20%) as a result of utilizing the miRInform® Thyroid Panel in conjunction with FNA cytopathology results. In 5 of the surgical referrals, an absence of mutations as analyzed by the miRInform® Thyroid Panel combined with a cytological diagnosis of FLUS, led to the cancellation of those surgeries. Conversely, the detection of the BRAF V600E mutation led to more extensive surgeries for 6 patients with micro-papillary thyroid carcinomas (mPTC).

Dr. Shifrin and his colleagues concluded that molecular marker analysis, which has a recommendation "C" (based upon expert opinion) in the current ATA (American Thyroid Association) guidelines, modifies surgical treatment in approximately 20% of patients in his study. A more aggressive surgical approach was utilized in patients with BRAF positive micro PTC. The rate of malignancy in FLUS, without presence of a mutation, is similar to the general patient population with multi-nodular goiter (MNG). Therefore, absence of mutations in nodules with FLUS, resulted in conservative therapy rather than surgery, again reducing overall healthcare costs.

Dr. Shifrin stated that,"molecular testing using the miRInform® Thyroid Panel altered my surgical approach with some patients, resulting in either no surgery or a more extensive surgery." He added "I believe that molecular testing will play an important role in the future management of patients with thyroid nodules. This testing is very easy to use and the results are received in a timely manner."

Additional findings from Dr. Shifrin's study appear to confirm the association between the BRAF V600E mutations and more aggressive thyroid cancers. Of the 24 patients in the study with papillary thyroid cancer (PTC), 16 had the BRAF mutation and 12 of these patients (75%) had lymph node metastases. Of the 16 PTC patients with extra thyroidal extension (ETE), 14 (87.5%) had the BRAF mutation. In addition, 12 patients with confirmed PTC had multifocality and of this group, 8 (66.7%) were positive for the BRAF mutation.

BRAF V600E was the most common mutation present; seen in 52.6% of patients with confirmed thyroid cancer. The association of specific mutations tested for in the miRInform® Thyroid Panel with different thyroid lesion subtypes was consistent with established precedent in the scientific literature surrounding molecular markers for thyroid cancer. BRAF V600E was exclusively found in malignant thyroid tumors (the majority being PTC), RAS was found in PTC as well as MNG, RET/PTC and PAX8/PPAR? were found in follicular thyroid carcinoma (FTC (News - Alert)).

About miRInform® Thyroid

miRInform® Thyroid is a Panel of molecular markers which improves preoperative diagnostic accuracy for patients with indeterminate thyroid nodules. In addition, the Panel can aid in the characterization of malignancy. The Panel consists of 7 analytically validated molecular markers and utilizes fine needle aspirate (FNA) specimens, collected in an easy-to-use nucleic acid preservation solution. The miRInform® Thyroid Panel is a cutting edge molecular diagnostic tool utilizing DNA and RNA based markers. Multiple peer-reviewed scientific studies have shown that the mutations and genetic rearrangements, assayed by miRInform® Thyroid, correlate with malignant thyroid nodules. Therefore, miRInform® Thyroid can aid physicians in diagnosis and patient management decisions.

About Asuragen

Asuragen is a fully integrated molecular diagnostic company and pharmaceutical services provider. Asuragen is empowered with a high level of expertise from its Ambion heritage to provide science driven solutions for novel assay development, CLIA and GLP testing services, which, combined with established cGMP manufacturing capabilities, allow it to span the spectrum of discovery, production and commercialization for novel personalized tests and companion diagnostics. The Company's product portfolio consists of the first-ever validated microRNA diagnostic test for pancreatic cancer, multiplex quantitative RNA-based assays, breakthrough solutions for the detection of the fragile X mental retardation gene (FMR1), Signature® Oncology products for the qualitative detection of gene translocations and mutations, an FDA-approved RNA tissue stabilization solution based upon RNAlater® technology, and industry-leading controls and standards engineered using its patented Armored RNA® technology. In addition, Asuragen offers a full range of contract manufacturing services for high quality QSR compliant reagents from plasmid DNA to in vitro synthesized RNA and complex assays for IVD cleared platforms. Asuragen is dedicated to developing new technologies that will become cutting edge clinical products. More information is available at the Company's website:

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