COMPANY:

HTG Molecular Diagnostics

"HTG Molecular Diagnostics, Inc...today announced there will be at least eight scientific abstracts featuring HTG’s proprietary HTG EdgeSeq™ technology presented at the 45th Annual San Antonio Breast Cancer Symposium (SABCS 2022) and at the 64th Annual American Society of Hematology (ASH) Annual Meeting."

"HTG Molecular Diagnostics, Inc...and OmiCure®, a leading European digital health company that develops and markets explainable AI-based therapeutic decision support software, announced a collaboration with OmiCure to implement the HTG Transcriptome Panel (HTP) as an alternative to RNA-Seq to inform the OmiCure test and help guide therapeutic decision-making across several cancer types."

"HTG Molecular Diagnostics, Inc...announced that the Fundación Instituto Valenciano de Oncología, located in Valencia, Spain (IVO), with its partners, the Fundación Pública Andaluza Progreso y Salud (FPS) and the Centro de Investigación Biomédica en Red (CIBER), have developed a laboratory-developed test (LDT) (the MPD Test) for the assessment of breast cancer recurrence based on their use of the HTG EdgeSeq™ technology."

"HTG Molecular Diagnostics...announced the customer publication of a peer reviewed journal article featuring the HTG Transcriptome Panel (HTP) less than one year after the breakthrough product’s commercial release...The article, published in Frontiers in Medicine by one of several participants in the Company’s HTP Early Adopter Program, applied the comprehensive HTP to query 19,398 mRNA targets in an effort to advance the understanding of how best to treat bladder cancer patients who do not fall into categories identified by routine tissue staining."

"HTG Molecular Diagnostics, Inc...announced its HTG EdgeSeq technology was highlighted in multiple scientific abstracts at the 2022 American Society of Clinical Oncology (ASCO) conference held in Chicago, Illinois...Abstracts were presented by HTG’s key biopharma customers and scientific collaborators from both the United States and Europe highlighting the unique features, benefits and results utilizing HTG’s proprietary HTG EdgeSeq gene expression profiling (GEP) technology. Prominent among the research presented was the HTG Transcriptome Panel (HTP). The HTP, released for commercial use in August 2021, enables the capture of comprehensive and reliable human transcriptome data using a fraction of the sample typically required by other GEP methods." "

"HTG Molecular Diagnostics, Inc...announced that it has improved the sample preparation protocol for its miRNA Whole Transcriptome Assay (miRNA WTA) so that it is now harmonized with the HTG Transcriptome Panel (HTP)...The harmonized protocol is designed to enable customers to process a single sample with HTG’s nearly 20,000 gene mRNA and 2,000+ miRNA transcriptome panels using a single sample lysate."

"HTG Molecular Diagnostics, Inc...expanded the potential markets and applications for its pioneering HTG Transcriptome Panel (HTP). Since launching HTP with commercial availability in the US and Europe in August 2021, HTG has completed validation of additional sample types that are more commonly used outside of oncology, and also expanded sequencing capabilities to facilitate easier testing of larger sample cohorts...Initially validated for neoplastic tissue, HTG has now validated HTP for use with normal FFPE tissue and other non-neoplastic tissues. In addition, the panel has been validated with PAXgene, a popular liquid blood-based sample type, and with extracted RNA from both fresh frozen and FFPE tissue samples."

"HTG Molecular Diagnostics, Inc...announced that it has exceeded $1 million of revenue recognized from sales of its HTG Transcriptome Panel (HTP) as of November 30, 2021. HTP was launched with commercial availability in the United States and Europe in early August 2021."

"HTG Molecular Diagnostics...and the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai)...announced they have entered into a new research collaboration as part of HTG’s Transcriptome Panel Early Adopter Program. HTG will provide in-kind laboratory services utilizing its proprietary HTG EdgeSeq technology in connection with multiple Icahn Mount Sinai bladder cancer studies."

"HTG Molecular Diagnostics, Inc...announced the commercial launch and immediate availability of its HTG Transcriptome Panel, designed to measure approximately 20,000 mRNA targets using the HTG EdgeSeq technology, in the U.S. and Europe. While HTG received its first orders for this product from Early Adopter Program (EAP) collaborators in June 2021, the HTG Transcriptome Panel is now commercially available to all HTG customers for purchase in kit form or as a service in HTG’s VERI/O laboratory. The HTG Transcriptome Panel is currently for use with the Illumina sequencing platforms."

"HTG Molecular Diagnostics, Inc...announced the creation of a new business unit, HTG Therapeutics. HTG plans to use this new drug discovery business unit to leverage its capabilities and expand upon the utility of the HTG EdgeSeq platform technology in the development of early stage drug candidates...This new business unit is a direct result and extension of HTG’s nearly 20,000 gene mRNA panel (the HTG Transcriptome Panel) that is expected to provide full transcriptome gene expression data from much smaller sample loads using a simplified workflow with a more rapid turnaround time...The HTG Therapeutics business unit plans to use the HTG Transcriptome Panel and a full epitranscriptome profiling technology evolved from the original HTG EdgeSeq technology (HTG EpiEdgeSeq) for the profiling of RNA modifications."

"HTG Molecular Diagnostics, Inc...today announced it has received the first commercial orders for its planned HTG Transcriptome Panel and has signed agreements with its first two Early Adopter Program (EAP) collaborators in Europe. HTG has now signed EAP agreements with customers in both the US and Europe and continues to progress toward its planned third quarter 2021 commercial launch of its HTG Transcriptome Panel, designed to measure approximately 20,000 mRNA targets using the HTG EdgeSeq technology."

"HTG Molecular Diagnostics, Inc...today announced it has completed product design lock for the HTG Transcriptome Panel and announced three Early Adopter Program (EAP) collaborators. HTG continues to progress in its development of a planned transcriptome panel using the HTG EdgeSeq technology. This panel, expected to be called the HTG Transcriptome Panel, will measure approximately 20,000 mRNA targets, with a planned research use only commercial launch in the third quarter of 2021."

"HTG Molecular Diagnostics, Inc...announced that its HTG EdgeSeq technology is highlighted in several posters being presented at the American Society of Clinical Oncology (ASCO) conference, being held virtually from June 4-8, 2021...Abstracts highlighting the use of HTG’s EdgeSeq technology at the ASCO conference include the following: Abstract 506: Durvalumab improves long-term outcome in TNBC: results from the phase II randomized GeparNUEVO study investigating neoadjuvant durvalumab in addition to an anthracycline/taxane based neoadjuvant chemotherapy in early triple-negative breast cancer (TNBC); Abstract 518: Palbociclib combined with endocrine treatment in breast cancer patients with high relapse risk after neoadjuvant chemotherapy: Subgroup analyses of premenopausal patients in PENELOPE-B; Abstract 519: Subgroup of post-neoadjuvant luminal-B tumors assessed by HTG in PENELOPE-B investigating palbociclib in high risk HER2-/HR+ breast cancer with residual disease."

"HTG Molecular Diagnostics...today announced that it has launched an Early Access Program for its whole transcriptome panel using the HTG EdgeSeq technology. The Early Access Program is intended to allow select customers access to the panel in their laboratories or through services to be performed in our development laboratory prior to commercial launch of this product."

"HTG Molecular Diagnostics, Inc...today announced the launch and immediate availability of the HTG EdgeSeq Pan B-Cell Lymphoma Panel in the United States and Europe. The HTG EdgeSeq Pan B-Cell Lymphoma Panel is commercially available for purchase in kit form or as a service in HTG’s VERI/O laboratory and is available in formats specific to both the Illumina and Thermo Fisher Scientific NGS platforms."

"HTG Molecular Diagnostics, Inc…today announced the signing of a Commercialization and Distribution Agreement (Master Agreement) with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN N.V…The 10-year agreement provides a foundation for both companies to combine their technological and commercial strengths with the goal to offer pharmaceutical companies global development, distribution and commercialization capabilities for companion diagnostic (CDx) assays based on HTG EdgeSeq, HTG’s novel RNA platform."