Thinly traded nano cap Motus GI Holdings (NASDAQ:MOTS) is up 21% premarket on increased volume in reaction to its announcement that the FDA has granted 510(k) clearance for its next-generation Pure-Vu System used to facilitate the cleaning of a poorly prepared colon during a colonoscopy.
Tuesday, June 11, 2019
Veracyte Details Real-World Performance of Sequencer in Thyroid Cancer Diagnosis
Veracyte, Inc. (Nasdaq: VCYT) announced today that findings from a new real-world study show that the company’s Afirma® Genomic Sequencing Classifier (GSC) helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test. Findings from the clinical utility study, conducted by researchers at The Ohio State University, appear online in the journal Thyroid and add to the growing body of independent evidence demonstrating the performance of the next-generation genomic test.
In the study, researchers evaluated records for all patients whose thyroid nodules were indeterminate for cancer based on cytopathology and who subsequently underwent molecular testing with the Afirma GSC or the original Afirma Gene Expression Classifier (GEC) between February 2011 and December 2018. Based on a cohort of 164 Afirma GSC-tested nodules and 343 Afirma GEC-tested nodules, they found that the next-generation test identified 58 percent more nodules as benign (76.2 percent vs. 48.1 percent) and that the rate of surgery among indeterminate thyroid nodules decreased by 66.4 percent (from 52.5 percent with the Afirma GEC to 17.6 percent with the Afirma GSC). The “benign call” rate among Hürthle cells – a common but difficult-to-diagnose thyroid nodule subtype – was also significantly higher using the Afirma GSC (88.8 percent vs. 25.7 percent).
“Our findings show that use of the Afirma GSC has enabled us to identify many more patients as benign when their thyroid nodules were indeterminate compared to the original test and, as a result, to help significantly reduce unnecessary thyroid surgeries among these patients,” said Jennifer A. Sipos, M.D., endocrinologist and professor at The Ohio State University and an author of the new study. “The next-generation test’s results were particularly striking for patients with Hürthle cells who previously had little other choice than to undergo diagnostic surgery, which carries risks and is costly.”
The new study marks the third recent independent publication by a major medical center demonstrating that its use of the Afirma GSC helped to significantly reduce surgeries in thyroid cancer diagnosis.
Zynerba Advances Cannabidiol Treatment With New Patent Win
Zynerba Pharmaceuticals Inc ZYNE 17.2%, a company that focuses on treating rare and near-rare neuropsychiatric disorders through cannabinoid therapies, said Tuesday it received a new U.S. patent for one of its cannabis-focused treatments.
Zynerba said the U.S. Patent and Trademark Office issued US Patent No. 10,314,792, titled “Treatment of Autism Spectrum Disorder with Cannabidiol.” The patent includes claims related to methods of treating autism through the administration of a synthetic cannabidiol.
Zynerba’s patent will expire in 2038 and is part of the company’s growing intellectual property portfolio that covers its cannabidiol product candidate, Zygel.
The announcement also follows a patent win titled “Treatment of Fragile X Syndrome with Cannabidiol,” which includes claims related to treating Fragile X Syndrome through a purified cannabidiol.
Zynerba continues to enroll patients for an open-label Phase 2 BRIGHT study which studies the safety, tolerability and efficacy of Zygel. The study will consist of children and adolescents with Autism Spectrum Disorder.
The company said it expects to report top-line data in the first half of 2020.
ContraVir up on positive CRV431 data in hepatitis B
Thinly traded nano cap ContraVir Pharmaceuticals (CTRV +21.4%) is up average volume in early trade in apparent response to just-published research on cyclophilin inhibitor CRV431 in a mouse model of hepatitis B (HBV).
The data, appearing in PLOS ONE, showed that CRV431 significantly reduced HBV DNA in the liver of transgenic mice in a dose-dependent manner while also reducing serum levels of surface antigen (HBsAg) (surface antigen signifies an active infection).
CRV431 is currently in Phase 1 development.
Kroger To Introduce CBD Products In 17 States
The grocery chain’s corporate affairs manager for its Michigan division, Rachel Hurst, said the company will begin the rollout this week in 17 states, according to The Detroit News.
Why It Matters
Kroger’s decision to sell CBD lotions, oils and other products makes it the latest major American chain to get involved with the products.
Others to recently enter the market include convenience store chain Sheetz, which announced in May 2019 that it would begin selling CBD at over 140 locations in the U.S. Others new CBD retailers include Walgreens Boots Alliance Inc WBA and CVS Health Corp CVS.
Retail giants like Walmart Inc WMT and Target Corporation TGT have also reportedly explored the possibility of CBD sales in recent months.
Small, struggling industries may benefit from CBD sales as well: one video rental store in Michigan reported a sales boost after it began offering CBD products.
What’s Next
The Food and Drug Administration held a hearing in May 2019 to hear from the CBD industry about the cannabinoid and its possible inclusion in edibles. No determination has been made at this time.
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