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$DMTK HOD
$DMTK DermTech Receives CPT® Proprietary Laboratory Assay Code from the American Medical Association
Chris Drosner for the State Journal
36 min ago
LA JOLLA, Calif.--(BUSINESS WIRE)--Oct 28, 2019--
DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the AMA has issued a Proprietary Laboratory Analyses (PLA) Common Procedural Terminology (CPT®) Code for the DermTech Pigmented Lesion Assay. This PLA code was published online with an effective date of July 1, 2019 and is included in the CPT 2020 publication. Medicare rate setting for this proprietary laboratory assay code is currently in process and is expected to be finalized effective for dates of service on or after January 1, 2020.
Burkhard Jansen, M.D., DermTech’s Chief Medical Officer commented, “The receipt of this CPT code is another step toward broadening our contracting and reimbursement success for the Pigmented Lesion Assay.”
DermTech’s Pigmented Lesion Assay uses RT-PCR to measure the gene expression of two genes, LINC00516 (long-intergenic non-coding RNA 00516) and PRAME (preferentially expressed antigen in melanoma) and identifies the malignant changes of melanoma on the genomic level.
https://www.valdostadailytimes.com/news/business/dermtech-receives-cpt-proprietary-laboratory-assay-code-from-the-american/article_94546e46-40eb-529f-b23e-af3801ece7e3.html
$DMTK 8.80 RTQ
$DMTK 8’s now.
$DMTK HOD +20% on good (relative) volume.
This still trades!?!
$DMTK popped over 7 this morning. Just not a lot to keep this from going higher. Waiting for the boom.
$DMTK. Possibly. CMS approval is the catalyst.
$DMTK DermTech’s Test Included in Expert Panel’s Clinical Management Recommendations for Cutaneous Melanoma
October 15, 2019 08:00 AM Eastern Daylight Time
LA JOLLA, Calif.--(BUSINESS WIRE)--DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a global leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today its inclusion in Clinical Management Recommendations, “Appropriate Use Criteria for the Integration of Diagnostic and Prognostic Gene Expression Profile Assays into the Management of Cutaneous Malignant Melanoma: An Expert Panel Consensus-Based Modified Process Assessment” published in the September issue of SKIN. The publication can be accessed at http://jofskin.org/index.php/skin/article/view/663.
“Appropriate Use Criteria for the Integration of Diagnostic and Prognostic Gene Expression Profile Assays into the Management of Cutaneous Malignant Melanoma: An Expert Panel Consensus-Based Modified Process Assessment”
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A panel of dermatologists and dermatopathologists with expertise in pigmented lesions, melanoma, and gene expression technology evaluated commercially available gene expression tests to provide recommendations for use in specific clinical situations. The expert panel recommended use of the non-invasive PLA (Pigmented Lesion Assay), or 2-Gene Expression Profile test, in cases in which patients present with atypical lesions requiring additional assessment beyond visual inspection in order to inform the decision to surgically biopsy. This recommendation closely aligns with the previously published utility data on the PLA (Ferris et al., Melanoma Research, 2018), which found that clinicians appropriately biopsied all PLA positive lesions while managing 99% of PLA negative lesions with surveillance and without surgical biopsies.
Senior author Dr. Darrell Rigel, Department of Dermatology, New York University Medical Center, commented, “Developments in genomics are expanding the diagnostic tools available to melanoma patients. The PLA specifically can aid clinicians in the biopsy decision of suspicious lesions and its 99% negative predictive value can help to rule-out melanoma with a high degree of certainty.”
“We are proud to be included in the panel’s clinical management recommendations,” said Todd Wood, Chief Commercial Officer for DermTech. “We are glad that experts are recognizing the clinical value of our non-invasive genomic test for melanoma, which enhances early detection while reducing unnecessary biopsies and scarring of non-cancerous lesions. We are excited to bring the technology to patients.”
About DermTech:
DermTech is a leader in the new category of medicine, precision dermatology. DermTech’s mission is to transform the practice of dermatology through more accurate diagnosis and treatment, and the elimination of unnecessary surgery, leading to improved patient care and lower costs. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, assess inflammatory diseases, and customize drug treatments. For additional information on DermTech, please visit DermTech’s investor relations site at: www.DermTech.com.
https://www.businesswire.com/news/home/20191015005201/en/DermTech’s-Test-Included-Expert-Panel’s-Clinical-Management/
$DMTK Adhesive tape–based method could help screen skin cells for melanoma
A scanning electrochemical microscope can detect a cancer biomarker in skin cells collected with sticky tape, no scalpel needed
https://cen.acs.org/analytical-chemistry/diagnostics/Adhesive-tapebased-method-help-screen/97/web/2019/10
Condolences AF.
$DMTK +6% above-avg volume.
$DMTK
Agreed. Pending CMS approval expected to be this quarter. Tiny float.
$DMTK DermTech Further Expands Patent Portfolio
October 07, 2019 08:00 AM Eastern Daylight Time
LA JOLLA, Calif.--(BUSINESS WIRE)--DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a global leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the issuance of patent, US 10,407,729, further expanding the company’s intellectual property and leadership position.
“Diagnosis of melanoma by nucleic acid analysis”
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This latest patent issued by the US Patent Office is entitled “Diagnosis of melanoma by nucleic acid analysis” and includes claims in connection with DermTech’s technology to non-invasively obtain genomic information for characterizing skin lesions. The patent includes claims related to using expression levels of PRAME (also known as preferentially expressed antigen in melanoma, which is overexpressed in this type of cancer) to differentiate melanoma from non-melanoma skin samples obtained via the company’s adhesive patch-based sample collection platform. DermTech has discovered that PRAME is a key gene in the assessment of melanoma using genomics.
“This patent expands on earlier work at DermTech and further highlights our ability to non-invasively obtain valuable genomic information, in this case on targets including PRAME, to support clinicians in their efforts to better serve patients with moles suspected of being melanomas. Our technology provides them with actionable genomic information that cannot be ascertained visually. Offering information on high value targets such as PRAME, and being able to do so without the need for surgical biopsies, carries the potential to transform the practice of dermatology,” said Dr. Zuxu Yao, DermTech’s Chief Scientific Officer.
About DermTech:
DermTech is a leader in the new category of medicine, precision dermatology. DermTech’s mission is to transform the practice of dermatology through more accurate diagnosis and treatment, and the elimination of unnecessary surgery, leading to improved patient care and lower costs. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, assess inflammatory diseases, and customize drug treatments. For additional information on DermTech, please visit DermTech’s investor relations site at: www.DermTech.com
https://www.businesswire.com/news/home/20191007005213/en/DermTech-Expands-Patent-Portfolio
$ALEAF coming off of a bottom. Keep an eye on it. Profitable weed company (one of the few). Way undervalued.
$DMTK sub 800k float, news expected anytime between now and EOY. Been adding.
$TENX lol.
$DMTK 760k float. In and adding.
$VIVE new: Viveve Submits Investigational Testing Application to Conduct Short-Term Feasibility Study in Stress Urinary Incontinence
September 19, 2019, 12:28 PM UTC
Three-month study provides strategic path forward in SUI and will compare Viveve's cryogen-cooled monopolar radiofrequency (CMRF) treatment to cryogen-only treatment and to inert sham treatment
ENGLEWOOD, CO / ACCESSWIRE / September 19, 2019 / Viveve Medical, Inc. (VIVE), a medical technology company focused on women's intimate health, announced today that it has submitted an Investigational Testing Application (ITA) to the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve's cryogen-cooled monopolar radiofrequency (CMRF) treatment to cryogen-only treatment and to inert sham treatment for the improvement of stress urinary incontinence (SUI) in women.
"We are pleased to announce that we have identified a strategic pathway to continue the advancement of our SUI clinical development program and pursuit of a label expansion for this indication on a global basis. If positive, we intend to proceed with our LIBERATE trial in the US, which could lead to regulatory clearance for our CMRF technology in the treatment of SUI, a condition that affects an estimated 25-30 million women worldwide," stated Scott Durbin, chief executive officer and director of Viveve.
The positive yet confounding results from the LIBERATE-International trial that compared the Viveve treatment (RF plus cryogen cooling) versus sham (cryogen cooling alone) showed clinically relevant and consistent results across all endpoints in both treatment groups. The company has determined that this result may indicate that the effect was unlikely due to placebo and that cryogen cooling alone may have a therapeutic effect. Based on further analysis of the clinical data, Viveve now plans to rapidly initiate a three-arm, three-month feasibility study, pending Health Canada approval of the ITA.
Using the SUI protocol from LIBERATE-International, the proposed study will compare Viveve's CMRF treatment to cryogen-only treatment and to an inert sham treatment in the control group. Results of the planned three-month feasibility study are targeted for read-out in April 2020 and, if positive, will be used in Viveve's re-submission of its investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) for approval to conduct the LIBERATE-U.S. trial for improvement of SUI in women.
The Company is also advancing VIVEVE II, an ongoing study using its CMRF technology for the improvement of sexual function in women. VIVEVE II is a randomized, double-blinded, sham-controlled trial that has completed enrollment of 250 subjects at 19 clinical sites in the United States. The top-line 12-month data read-out of the VIVEVE II trial is expected in April 2020.
About the International SUI Feasibility Study
The international three-arm SUI feasibility study is a prospective, randomized, single-blind trial comparing both the Viveve cryogen-cooled monopolar radiofrequency (CMRF) treatment and cryogen-only treatment versus inert sham treatment using the SUI treatment protocol in improving mild-to-moderate SUI, assessed using multiple objective endpoints, including the 1-hour Pad Weight Test, 24-hour Pad Weight Test, and 3-day voiding diary at three-months post treatment. Three clinical sites in Canada will enroll a total of approximately 36 subjects (12 per treatment arm) that will be randomized on a 1:1:1 ratio to each of the three study arms. Randomization will be stratified by each study site.
The primary efficacy endpoint is the mean change from baseline in the standardized 1-hour Pad Weight Test at three months post-treatment. The study design also includes exploratory endpoints as well as safety follow-up throughout the study.
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/viveve-submits-investigational-testing-application-122800012.html
$VIVE O/S only 600k now.
$VIVE bouncing on R/S Naz compliance news.
“$TENX” that is. Apparently my dyslexia is showing. Lol.
$TEXN I’m with you there. I have time. Big payday coming imo. GLTA!
$TENX bids moving up.
$TENX beat me to it. Going to boom soon imo.
$TENX Volume/price increasing, I’ll take it.
$TENX 1.45 got tapped.
$TENX 1.40
$TENX hmm... HOD.
$TENX HOD, tiny float.
$VRUS tempting here, would like it to hit .02 first.
$TENX so thin. Any volume surge should spike this.
Strong DD! lol.
$INNT giggity
$INNT boom
$INNT going.
$INNT HOD, 2x avg 10 day volume.
$CVSI on watch
$INNT watch for the BOOM