Assay expands company's leadership in precision medicine and cell and gene therapy BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt),... Read more
Revenue of $650 million; (4)% reported growth; (3)% organic growth
First quarter GAAP EPS of $0.21; Adjusted EPS from continuing operations of $0.98
Reaffirms full year 2024 organic growth and adjusted EPS guidance WALTHAM, Mass. / Apr 29, 2024 / Business Wire / Revvity, Inc. (NYSE: RVTY), today reported financial results for the first quarter ended March 31, 2024.
The Company reported GAAP earnings per share of $0.21, as compared to $4.50 in the same period a year... Read more
SANTA CLARA, Calif. / Apr 29, 2024 / Business Wire / Agilent Technologies, Inc. (NYSE: A) today announced Simon May has been named president of the company’s Diagnostics and Genomics Group (DGG). May, previously executive vice president and president of the Life Science Group at Bio-Rad Laboratories, will join Agilent on May 6.
“We are excited to welcome Simon May to the Agilent team,” said Padraig McDonnell, COO and CEO-elect. “Simon’s deep technical knowledge,... Read more
Toronto, Ontario--(Newsfile Corp. - April 26, 2024) - LevelJump Healthcare Corp. (TSXV: JUMP) (OTC Pink: JMPHF) (FSE: 75J) ("LevelJump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that it has entered an agreement to acquire a pre-1954 pharmacy charter corporation ("Pharmacy License").
The Company has agreed to purchase the Pharmacy License for $1,900,000, to be paid as $1,800,000 in cash and 100,000 shares of JUMP preferred... Read more
SAN DIEGO / Apr 25, 2024 / Business Wire / DexCom, Inc. (Nasdaq: DXCM) today reported its financial results as of and for the quarter ended March 31, 2024.
First Quarter 2024 Financial Highlights: Revenue grew 24% year-over-year to $921.0 million on a reported basis and 25% year-over-year on an organic1 basis.
U.S. revenue and international revenue both grew 24% on a reported basis and international revenue grew 26% on an organic1 basis, all on a year-over-year basis.
GAAP... Read more
Award Seeks to Demonstrate Feasibility of Manufacturing mRNA Vaccines in Only 7 Days STONY BROOK, NY / ACCESSWIRE / April 25, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced the award of a contract from HDT Bio for the purpose of rapid, next-generation vaccine development under a ‘Project NextGen: Enabler' award to HDT Bio (the "Project"). The Project seeks to facilitate the rapid production... Read more
Groundbreaking topline results demonstrated sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%
690 subjects analyzed including previously unexamined and reported patients from Company’s ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm
The power to determine advanced adenoma, lesions in a pre-cancerous stage, can change the entire CRC... Read more
Quasi-randomized study demonstrates the value of Dario's integrated approach to provide one solution for members to manage diabetes, pre-diabetes, blood pressure, weight and taking a GLP-1 NEW YORK, April 25, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced today new research published in the leading peer-reviewed journal for digital health and medicine, Journal of Internet Medicine... Read more
WALTHAM, Mass. / Apr 25, 2024 / Business Wire / Revvity, Inc. (NYSE: RVTY) will present at the BofA Securities 2024 Health Care Conference on Tuesday, May 14, 2024 at 8:40 a.m. PT in Las Vegas, NV.
Senior Vice President and Chief Financial Officer Max Krakowiak will provide an update on the Company and its strategic priorities. To register, click here.
A live audio webcast will be available on the Events section of the Company’s website at www.revvity.com. A replay of... Read more
Updates Full-Year Guidance Results from Continuing Operations for first quarter 2024 versus last year: Revenue: $3.18 billion versus $3.04 billion or up 4.6% | Base Business grew 6.7%
Diluted EPS: $2.69 versus $2.34
Adjusted EPS: $3.68 versus $3.46 Full-Year 2024 Guidance: Raised midpoint and narrowed range of adjusted EPS to $14.45 to $15.35; Free Cash Flow remains $1.00 billion to $1.15 billion
Year to date announced/completed five acquisitions that support... Read more
Highlights Net business wins in the quarter of $2,654 million; a net book to bill of 1.27, an increase of 9.9% on quarter one 2023. Closing backlog of $23.4 billion, an increase of 2.5% on quarter four 2023 and 10.1% on quarter one 2023. Quarter one revenue of $2,090.4 million representing an increase of 5.7% on prior year revenue and 5.4% on a constant currency basis. Quarter one adjusted EBITDA of $444.0 million or 21.2% of revenue, an increase of 11.3%... Read more
Venlo, the Netherlands, April 24, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAseq xHYB Mycobacterium tuberculosis Panel for research use, a new tool in the fight against tuberculosis (TB), the world’s leading infectious disease killer.
Building on QIAGEN’s ongoing efforts to support global TB management and control, which include the leading diagnostics test QuantiFERON-TB Gold Plus, the new panel... Read more
SOUTH SAN FRANCISCO, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, today announced that two abstracts on 23ME-00610, a first-in-class anti-CD200R1 antibody, have been accepted for poster presentations at the 2024 ASCO Annual Meeting, taking place May 31 - June 4 in Chicago. 23andMe will present clinical data, including preliminary efficacy and exploratory biomarker analyses,... Read more
Collaboration with the US Department of Defense’s largest military health organization underway SAN ANTONIO / Apr 24, 2024 / Business Wire / bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today announced David Elzi, Ph.D., has been named Vice President of Product Development to accelerate the development of new diagnostics... Read more
SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO), today announced the results of an implementation study conducted by researchers at University Medical Center Groningen that compared optical genome mapping (OGM) to traditional cytogenetic methods for the detection of structural variants (SVs) in bone marrow aspirate (BMA) samples. OGM has been shown to regularly detect SVs missed by other methods, as a result of the higher resolution... Read more
WALTHAM, Mass. / Apr 24, 2024 / Business Wire / Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 30, 2024.
First Quarter 2024 Highlights First quarter revenue was $10.34 billion.
First quarter GAAP diluted earnings per share (EPS) increased 4% to $3.46.
First quarter adjusted EPS increased 2% to $5.11.
Advanced our proven growth strategy, launching a range of high-impact,... Read more
New and improved workflow now available that pairs Revvity’s T-SPOT™.TB test with the Auto-Pure 2400 liquid handling platform
Substantially lowers hands-on time, allowing for increased lab productivity WALTHAM, Mass. / Apr 24, 2024 / Business Wire / Revvity, Inc. (NYSE: RVTY) today announced the launch of the Auto-Pure 2400 liquid handler from Allsheng for use with the T-SPOT.TB test. The Auto-Pure 2400 platform is easy to use and designed to provide efficient workflows... Read more
HENDERSON, Nev., April 23, 2024 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, has announced that its Nu.Q® Vet Cancer Test is now available in-clinic to veterinarians across the U.S and Europe through Antech, a leading veterinary diagnostics company.
Antech's in-clinic version of the Nu.Q® Canine Cancer Test operates on the Element i+® Analyzer, providing veterinarians with a rapid, accurate and... Read more
First quarter revenues of $2.37 billion, up 1.5% from 2023
First quarter reported diluted earnings per share ("EPS") of $1.72, down 3.4% from 2023; and adjusted diluted EPS of $2.04, flat with 2023
Full year 2024 revenues now expected to be between $9.40 billion and $9.48 billion; reported diluted EPS now expected to be between $7.57 and $7.82; and adjusted diluted EPS expected to be between $8.72 and $8.97 SECAUCUS, N.J., April 23, 2024 /PRNewswire/ -- Quest Diagnostics... Read more
WASHINGTON, April 23, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the quarter ended March 29, 2024. All results in this release reflect only continuing operations unless otherwise noted.
Key First Quarter 2024 Results Net earnings were $1.1 billion, or $1.45 per diluted common share and non-GAAP adjusted diluted net earnings per common share were $1.92.
Revenues decreased 2.5% year-over-year to $5.8 billion... Read more
Revenue of $511.0 million in the first quarter of 2024 increased 17.7% from revenue of $434.1 million for the comparable prior-year period, representing a backlog conversion rate of 18.2%.
Net new business awards were $615.6 million in the first quarter of 2024, representing an increase of 10.8% from net new business awards of $555.8 million for the comparable prior-year period, which resulted in a net book-to-bill ratio of 1.20x.
First quarter of 2024 GAAP net income... Read more
MELBOURNE, Australia, April 23, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE, “Company”, “GTG”, or “Genetic Technologies”), a global leader in guideline-driven genomics-based tests in health, wellness and serious diseases, today announces the closing of its previously announced registered offering for the purchase and sale of 1,000,000 American Depositary Shares (“ADSs”) (or ADS equivalents in lieu thereof), each representing... Read more
Demonstrates commitment to generating real-world clinical evidence to change disease management and improve patient outcomes AUSTIN, Texas / Apr 22, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced that it has passed a significant milestone with the publication of more than 200 peer-reviewed papers highlighting Natera’s technology in the scientific literature.
Landmark cutting-edge science... Read more
News Summary: New line of GTxResolve™ Premier SEC Columns provide higher sensitivity, resolution, and throughput to accelerate the development of cell & gene-based therapeutics.
Reduces problematic non-specific binding, minimizes mobile phase method development challenges, and provides higher throughput separation efficiency.
Increases resolution up to 50% for components present within mRNA, lipid nanoparticles (LNP), and viral vectorsi for more confident... Read more
Company's AD-Detect™ Portfolio Offers AB 42/40 and Other Plasma Biomarker Testing, Alongside Traditional Cerebrospinal Fluid and Genetic Tests, to Provide Robust Offering in Brain Health SECAUCUS, N.J., April 22, 2024 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced the launch of a new blood biomarker test for phosphorylated tau 217, or p-tau217. P-tau217 is a biomarker associated with Alzheimer's Disease... Read more
PALO ALTO, Calif. / Apr 22, 2024 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee is scheduled to review the premarket approval (PMA) application for the company’s Shield™ blood test for colorectal cancer (CRC) screening on Thursday, May 23, 2024.
“We look forward to discussing with the FDA... Read more
MELBOURNE, Australia, April 19, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE, "Company", "GTG", or "Genetic Technologies"), a global leader in guideline-driven genomics-based tests in health, wellness and serious diseases, today announced that it has entered into a definitive agreement for the purchase and sale in a registered direct offering of 1,000,000 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each representing... Read more
FT. MYERS, Fla. / Apr 18, 2024 / Business Wire / NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, today announced two promotions within its senior leadership team, effective immediately.
Warren Stone has been promoted to Chief Commercial Officer and will lead NeoGenomics’ clinical and pharma services commercial teams. Stone will be responsible for sales, marketing, pharma project management, commercial enablement, scientific affairs, and support... Read more
Bionano, a global leader in the transformation of the cytogenetic workflow with optical genome mapping (OGM), has entered into a strategic partnership with Hangzhou Diagens Biotechnology Co., Ltd. (Diagens), the pioneering leader in artificial intelligence (AI) chromosome karyotype analysis technology. Their joint endeavor aims to commercialize the first ever cytogenetic workflow that integrates OGM plus AI chromosome karyotype analysis
Diagens will become an original... Read more
SALT LAKE CITY, April 16, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that Prenatal Diagnosis has published a study1 demonstrating exceptional positive predictive value (PPV) for 22q11.2 microdeletion screening using Myriad’s prenatal cell-free DNA (pcfDNA) screen, Prequel®, which incorporates fetal fraction amplification.
Prior studies from other commercial pcfDNA laboratories have... Read more
Announces Plan to Reduce Annualized Operating Expense Run Rate by $50 - $75 Million
Q1 2024 Earnings Conference Call Scheduled for May 9, 2024 MENLO PARK, Calif., April 16, 2024 /PRNewswire/ – PacBio (NASDAQ: PACB) today announced preliminary, unaudited revenue for the quarter ended March 31, 2024.
Preliminary First Quarter Results Preliminary revenue of $38.8 million, roughly flat compared with $38.9 million in the prior-year period.
Instrument... Read more
BRISBANE, Calif. / Apr 16, 2024 / Business Wire / CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients – has appointed John W. Hanna as its new President and Chief Executive Officer, and member of the Company’s Board of Directors, effective April 15, 2024.
“John is an outstanding... Read more
SANTA CLARA, Calif. / Apr 15, 2024 / Business Wire / Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification. This certification demonstrates that the assay meets the higher standards established by IVDR. It ensures the continued availability of this trusted qualitative assay to clinical geneticists and other healthcare professionals throughout the EU.
In vitro diagnostic devices, which include... Read more
SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment of metabolic function-associated... Read more
Innovative GFAP blood biomarker test expands Labcorp's portfolio of tests for diseases including Alzheimer's disease, multiple sclerosis, glioblastoma and brain injuries BURLINGTON, N.C., April 15, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the availability of the nation's first test for glial fibrillary acidic protein (GFAP), a critical blood-based biomarker for the early detection... Read more
New CRO system-level expansion elevates data stewardship and enables organizations to gain more insight with less oversight WALTHAM, Mass. / Apr 15, 2024 / Business Wire / Today, Revvity, Inc. (NYSE: RVTY) announced that its software and informatics division, Revvity Signals, will launch Signals SynergyTM, a software solution designed to drive greater collaboration, project management, and data exchange between pharmaceutical and biotechnology sponsors with their external... Read more
MADISON, Wis. / Apr 15, 2024 / Business Wire / Exact Sciences (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, announced today the appointment of Aaron Bloomer as chief financial officer (CFO), effective May 15, 2024.
Mr. Bloomer brings to Exact Sciences more than 15 years of finance and accounting experience. He previously held leadership positions at Baxter International and 3M, where he helped improve financial results, drove operational rigor,... Read more
Ribbon-cutting included support from Mayor Wood of South Salt Lake and other dignitaries SALT LAKE CITY, April 12, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it held the ribbon cutting event for its new manufacturing facility yesterday in the City of South Salt Lake. The facility... Read more
ProActive study shows Natera’s Prospera Kidney™ test detects rejection five months before biopsy AUSTIN, Texas / Apr 11, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA (dd-cfDNA) test as a leading indicator of kidney transplant rejection. The published manuscript can be found... Read more
Powered by digital pathology and AI algorithms, Patholytix Foresight drives speed and quality in toxicologic pathology practices WILMINGTON, Mass. & DUBLIN / Apr 11, 2024 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of Patholytix Foresight, a non-clinical artificial intelligence (AI) decision support tool developed in collaboration with Deciphex, an innovator in pathology AI. By combining Deciphex’s unique... Read more
SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study from Penn State College of Medicine that used optical genome mapping (OGM) to search for clinically and biologically relevant genomic variations in pediatric B-cell acute lymphoblastic leukemia (B-ALL). The study also used whole genome sequencing (WGS) for variant detection and evaluated the two approaches side-by-side and the potential... Read more
Toronto, Ontario--(Newsfile Corp. - April 10, 2024) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") a biotech company developing the industry's leading telomere technology platform with diagnostic and prognostic applications measuring genomic instability in oncology, is pleased to announce that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to TELO's laboratory at the MaRS Center in Toronto,... Read more
MALVERN, Pa., April 10, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the publication of significant clinical findings in Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation, the premier journal in the field of neuromodulation. This analysis... Read more
Studies include a Randomized Controlled Trial demonstrating significant reduction in perceived stress for teens NEW YORK, April 10, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced today two new studies published in the leading peer-reviewed journal for digital health and medicine, Journal of Internet Medicine (JMIR), including a Randomized Controlled Trial (RCT) demonstrating... Read more
101 patients enrolled TORONTO, April 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Enrollme... Read more
Helping hospital and emergency room customers respond to the critical demand for enhanced opioid testing SAN DIEGO / Apr 10, 2024 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) has added the ARK™ Fentanyl II Assay to its U.S. Vitros® XT 7600 and 5600 Integrated Systems as well as its Vitros® 4600 Chemistry System menu of assays as a MicroTip® Partnership Assay (“MPA”). This Fentanyl assay will help hospital and emergency room customers respond to the... Read more
The first at-home mpox testing kit provides patients with convenience and privacy to test for mpox, supports physicians in detection and treatment BURLINGTON, N.C., April 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of... Read more
Studies highlight advancements in technology to detect cell-free DNA and rapid turnaround time in a real-world clinical setting LOUISVILLE, Colo. / Apr 09, 2024 / Business Wire / Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. These presentations highlight advancements in liquid... Read more
New Data Presented at the European Heart Rhythm Association Conference Marks First Scientific Presentation on HeartBeam AI, the Company’s Deep Learning Technology
Data Shows HeartBeam AI Combined with VCG Greatly Improves Detection of Atrial Flutter over Single-Lead ECGs Found in Leading Smartwatches and Other Wearables SANTA CLARA, Calif. / Apr 09, 2024 / Business Wire / HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac... Read more
BERKELEY, Calif. and MAINZ, Germany, April 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today financial results for the fiscal year ended December 31, 2023.
“This past fiscal year represented an important period of progress for the Company highlighted by reporting results from our groundbreaking ColoFuture and eAArly DETECT... Read more
