SpeeDx Pty. Ltd. Raises $15 Million From U.S. Investment Partnership
SpeeDx Pty. Ltd., the developer of transformative new molecular diagnostic solutions, today announced it had raised up to US $10 million in additional equity investment from US-based Northpond Ventures. This follows an original investment of US $5 million from Northpond Ventures in April 2019.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190805005359/en/
SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as therapeutic guidance capabilities. (Photo: Business Wire)
SpeeDx CEO Colin Denver said, “The funds raised will help expedite our international expansion and leverage strategic relationships with global partners. We are working with key researchers and organizations around the globe with a shared goal of providing clinicians with the information and guidance they need to address the urgent issues related to antibiotic resistance and better management of infectious diseases.”
“SpeeDx has developed significant strategic partnerships and their recent successes demonstrate true global potential,” said Michael Rubin M.D., Ph.D., Founder and CEO of Northpond Ventures. “They are positioned to become a world leader with technology that will benefit millions of patients globally.”
SpeeDx recently announced a partnership with GlaxoSmithKline to support antibiotic development work and a partnership with Cepheid on the FleXible cartridge program, allowing a SpeeDx test ( Resistance Plus® MG) to run on the GeneXpert platform. Resistance Plus MG supports Resistance Guided Therapy for the sexually transmitted infection Mycoplasma genitalium (Mgen), an approach recommended in management guidelines in response to rising rates of macrolide resistance observed with traditional Mgen treatment. With a global installed base over 22,000 GeneXpert Systems, this partnership with Cepheid could see Resistance Guided Therapy applied in multiple settings where actionable treatment information is needed quickly.
SpeeDx is now looking to accelerate growth, with commercial scale-up to support further penetration into global markets. Clinical studies in the U.S. are nearing completion for Resistance Plus MG with submission to FDA likely before the end of 2019. Resistance Plus® GC, for the detection of gonorrhea and susceptibility to ciprofloxacin treatment, has also been granted Breakthrough Device designation by the FDA and has begun the process for clearance in the U.S. Results from this test can be used to guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant infections.
SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as therapeutic guidance capabilities. The company is based in Australia with offices in Austin and London, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infection (STI), antibiotic resistance markers, and respiratory disease. For more information about SpeeDx please see: https://plexpcr.com
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Idriverplus Joins the “Automate with Velodyne” Ecosystem29.5.2020 20:31:00 CEST | Press release
Velodyne Lidar, Inc. and Idriverplus today announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. Through the program, Velodyne will further collaborate with Idriverplus to support its continued innovation and promote Idriverplus autonomous vehicles, including street cleaners, passenger cars and logistics vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200529005589/en/ Velodyne Lidar, Inc. and Idriverplus announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. (Photo: Velodyne Lidar) Recently, Velodyne signed a multi-year sales agreement with Idriverplus to provide Puck™ sensors for the mass production of autonomous vehicles. Idriverplu
Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25thEuropean Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone. The Pevonedistat-2001 trial was designed as a proof-of-concept study in patients with HR-MDS, higher-risk chronic myelomonocytic leukemi
Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3 “Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for peo
Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig ® (ponatinib) for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings29.5.2020 14:00:00 CEST | Press release
Incyte (Nasdaq:INCY) today announced that data from the interim analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial, which was sponsored by Takeda and co-funded by Incyte, will be presented during an oral session at the upcoming 2020 American Society of Clinical Oncology Virtual Meeting (ASCO20; May 29 – May 31) (Abstract #7502)1; and at the virtual 25th Congress of the European Hematology Association (EHA25; June 11 – 14) (Abstract #S172)2. The OPTIC trial is an ongoing randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig® (ponatinib) over a range of three starting doses (45 mg, 30 mg, 15 mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML), who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow up of approximately 21 months, data from the interim analysis of the OPTIC trial show that the optimal benefit-r
Takeda to Present Data from the ICLUSIG ® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML29.5.2020 14:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the 25thEuropean Hematology Association (EHA) Annual Meeting. The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG® (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow-up of approximately 21 months, data from the interim analysis of OPTIC show that the optimal benefit-risk profile for ICLUSIG in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-A
LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test29.5.2020 13:57:00 CEST | Press release
LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours. Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA. LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing