DdPCR

Biodesix Announces First Quarter 2024 Results Driven by Growth in Lung Diagnostic Testing for Lung Nodule Management

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星期三, 五月 8, 2024
Radiology, Pharmaceutical, Research, Oncology, Software, Medical Devices, Hospitals, Genetics, Data Management, Stem Cells, Science, Practice Management, Technology, Clinical Trials, Medical Supplies, FDA, Biotechnology, Surgery, Health, CO, Cancer, Depreciation, Webcast, DdPCR, Forecasting, Growth, MSKCC, Net operating loss, Patient, COVID-19, Acquisition, Adjustment, AACR, Bank statement, EGFR, GAAP, AstraZeneca

In the first quarter, we delivered approximately 11,900 Lung Diagnostic tests, an increase of 57% over the prior year comparable period and our seventh consecutive quarter of greater than 50% year-over-year volume growth.

Key Points: 
  • In the first quarter, we delivered approximately 11,900 Lung Diagnostic tests, an increase of 57% over the prior year comparable period and our seventh consecutive quarter of greater than 50% year-over-year volume growth.
  • Our team is off to a strong start, helping to impact more patients every quarter in the large and underserved lung nodule diagnostic testing market.
  • Record quarterly gross profit margin of 79% versus 65% for the first quarter 2023 and 77% for the fourth quarter of 2023.
  • The Company reaffirms its 2024 financial outlook and expects to generate between $65 million and $68 million in total revenue in 2024.

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

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星期五, 五月 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

Retrieved on: 
星期五, 五月 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

Oncocyte and Bio-Rad Partner on Global Launch of Transplant Assay

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星期四, 四月 11, 2024
FDA, Bio-Rad Laboratories, Security (finance), Partnership, Research, DdPCR, PCR, Transplant, OCX, IVD, Pharmaceutical industry

IRVINE, Calif., April 11, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced a partnership agreement with Bio-Rad Laboratories (NYSE: BIO), a global leader in life science research and clinical diagnostics products, for the commercialization of its research use only GraftAssure™ assay, powered by Droplet Digital™ PCR (ddPCR™)*. The new product is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and EU and more broadly in the second half of the year.

Key Points: 
  • The new product is expected to launch in Q2 2024 to a select group of academic transplant centers in the US and EU and more broadly in the second half of the year.
  • As part of the agreement, Bio-Rad and Oncocyte will co-market the assay inside the US and Germany, with Oncocyte acting as commercial lead.
  • Outside these countries Bio-Rad has been granted exclusive global distribution and commercial rights.
  • Additionally, Bio-Rad has been granted an option for IVD commercial rights at FDA clearance, subject to meeting specific objectives.

Biodesix to Present New Data on Liquid Biopsy Technologies at AACR 2024 Annual Meeting

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星期二, 四月 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Artificial Intelligence, Technology, Nucleic acid thermodynamics, Trial of the century, Plasma, DdPCR, Digital, DNA, Patient, AACR, EGFR, NSCLC, AstraZeneca, Liquid biopsy, Medical imaging

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.

Key Points: 
  • 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 biopsy technologies that detect cell free DNA (cfDNA) and the clinical value of rapid turnaround time to detect actionable tumor mutations in a real-world clinical setting.
  • Biodesix supported this research by providing the EGFRm testing using Droplet Digital™ PCR* (ddPCR™) on plasma samples collected prior to treatment and three and six weeks after treatment initiation.
  • EGFRm testing is offered in a clinical setting by Biodesix as part of the GeneStrat® ddPCR targeted mutation test.

Sarepta Therapeutics Announces Positive Data from Part B of MOMENTUM, a Phase 2 Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51

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星期一, 一月 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Ageing, Patient, Therapy, Magnesium, Part, SRPT, Hypokalemia, Sarepta Therapeutics, DdPCR, Magnesium deficiency, PIN, Dystrophin, Catholic higher education, Duchenne muscular dystrophy, Interest, Vaccine

SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

Key Points: 
  • SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.
  • Consistent dystrophin expression was seen in ambulatory (4.76%, n=11) and non-ambulatory (5.67%, n=9) participants at 28 weeks.
  • Hypomagnesemia has previously been identified in patients taking SRP-5051 and was managed and monitored through prophylactic magnesium supplementation as part of the study protocol.
  • Hypomagnesemia has been seen in earlier clinical studies of SRP-5051 and, throughout MOMENTUM Part B, supplemental magnesium was administered prophylactically.

Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits

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星期六, 十二月 9, 2023
Exposition, Tumor microenvironment, Bone marrow, Dose, Cytokine release syndrome, IPSC, Tissue, Pharming, DNA, Society, Therapy, DdPCR, Follicular lymphoma, Serum, Interleukin 2, Event, ASH, Neurotoxicity, Poster, Century, Ink, Cell, Patient, Malignancy, Webcast, Allotransplantation, Lymphoma, Science, Pharmaceutical industry

PHILADELPHIA, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12 in San Diego. The poster, titled, “Multiple Doses of CNTY-101, an iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study”, is available on the Scientific Resources page of the Company’s website.

Key Points: 
  • “We are thrilled that the initial clinical evidence for CNTY-101 provides support for the potential for Allo-Evasion™ to enable a multi-dosing regimen without the need for continued lymphodepletion.
  • Cycles one and two included three days of lymphodepletion (LD), whereas cycles three through seven were given with no LD.
  • Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion.
  • The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website.

Bionano Announces Publication Demonstrating Utility of OGM to Assess Genome Integrity of CRISPR-Edited Cells as Part of Gene Therapy Development

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星期三, 十一月 29, 2023
Gene editing, CD40LG, SVS, OGM, CRISPR, Quality control, SAN, Doctor of Philosophy, PCR, DdPCR, Cancer, Genomics, Infection, Cell, Liver disease

The study authors first validated OGM’s performance at high coverage to capture unexpected gene editing events and found that it outperformed karyotyping’s resolution and sensitivity.

Key Points: 
  • The study authors first validated OGM’s performance at high coverage to capture unexpected gene editing events and found that it outperformed karyotyping’s resolution and sensitivity.
  • OGM then revealed the presence of concameters missed by the ddPCR assay, indicating that 20-50% of the edited cells expressing the rescued gene did not undergo precise editing.
  • In addition, OGM detected 11 nonrecurring SVs outside of the target locus, demonstrating its genome-wide ability to detect off-target events.
  • The expansion of gene therapy faces risks due to both on-target and off-target structural variations that may be introduced during CRISPR-Cas9 genome editing.

CCM Biosciences Announces Launch of 5Prime Sciences Business Unit

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星期三, 十二月 27, 2023
Research, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, RNA, Entrepreneurship, Polymerization, NGS, Princeton University, DNA, Doctor of Philosophy, PCR, DdPCR, CDX, Diagnosis, Spectrum, Big data, Gene, IVD, Bias, Machine learning, Enzyme, CCM, Q5, RNA-Seq, Massive parallel sequencing, Algorithm, Synthetic biology, History, Fragile X syndrome, Vaccine

Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology.

Key Points: 
  • Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology.
  • 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.
  • In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes.
  • ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.

Be Bio Announces New Preclinical Data Demonstrating its Novel Engineered B Cell Medicine (BCM), BE-101, Produces Active and Sustained Levels of Factor IX for the Treatment of Hemophilia B​

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星期日, 十二月 10, 2023
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, Partial thromboplastin time, Safety, Haemophilia, Food, HDR, Engineering, Plasma, Hematology, Bio-MEMS, Mortality, CCR5, Mouse, Multimedia, BCMS, PCR, Defence Scientific Advisory Council, World government, WFH, FIX, Committee, Availability, Investigational New Drug, World Federation of Hemophilia, Factor IX, Human services, Cas9, Bleeding, Person, Pain, Drug discovery, American Society of Hematology, DdPCR, Coronavirus Scientific Advisory Board, Society, Cell, BCM, Real-time, AAV, ELISA, Immunoglobulin G, Therapure BioPharma Inc, Pharmaceutical industry, Vaccine

“We are excited by these findings as we advance this novel BCM into clinical development to address enduring unmet medical needs for people living with hemophilia B.

Key Points: 
  • “We are excited by these findings as we advance this novel BCM into clinical development to address enduring unmet medical needs for people living with hemophilia B.
  • Many people living with hemophilia B still experience bleeding episodes, irreversible joint damage and pain with current extended-release factor IX biologic therapy.
  • “Our goal is to create a new, potentially transformative treatment option that will provide people with hemophilia B the freedom to live a normal life, free of limitations from hemophilia B.
  • The data confirmed the expected biodistribution of FIX-expressing BCMs in bone marrow tissue, where they engraft stably over time.