ADDF Invests $1.18M to Standardize p-tau217 Blood Tests for Alzheimer’s Diagnosis

GSK Reports Positive Interim Results for DREAMM-7 Trial of Blenrep in Multiple Myeloma

Molbio Diagnostics Invests $30 Million in OptraSCAN to Revolutionize Digital Pathology

BioNTech Acquires Chinese Oncology Firm Biotheus for $950M

The Care and Protection of Children Trust

CPCT Launches Groundbreaking Initiative to Provide Lifelong Free Treatment for Children with Spinal Muscular Atrophy (SMA) in Karnataka

Early Comprehensive Genomic Profiling Improves Cancer Treatment Outcomes, Study Shows

EMA Reverses Decision, Recommends Limited Approval for Eisai and Biogen’s Alzheimer’s Drug Leqembi

Exact Sciences Unveils Advances in Multi-Cancer Early Detection with Cancerguard™ Test

MSD and LaNova Medicines Enter Exclusive Global License Agreement for Novel Cancer Therapy, LM-299

Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

FDA Grants Accelerated Approval to PTC Therapeutics' KEBILIDI™, the First Gene Therapy for AADC Deficiency in the U.S.

Association for Molecular Pathology Publishes Joint Consensus Report on SARS-CoV-2 Genomic Surveillance for Hospitals and Public Health Laboratories

Philips India Unveils Advanced Azurion Imaging System to Revolutionize Cardiac and Neurovascular Care

Tempus AI Study Highlights Benefits of Dual RNA and DNA Sequencing for Advanced Lung Cancer

Ontada and Datavant Partner to Expand Access to Real-World Oncology Data for Accelerated Cancer Innovation

Home
/
insight
/
details

Beyond Amplification: Exploring Clinical Frontiers with Digital PCR (dPCR)

NextEdge Admin

02 Feb 2024

3 min 51 sec

In the 1980s, Kary Mullis introduced the Polymerase Chain Reaction (PCR), a groundbreaking method in molecular biology enabling the selective amplification of DNA sequences. Initially qualitative, PCR found applications in DNA cloning and genotyping. The subsequent evolution led to Quantitative PCR (qPCR), emphasizing real-time monitoring and quantification through fluorescence signals with application in Gene expression analysis, pathogen detection, quantitative analysis of DNA. Further advancements in the 1990s gave rise to Digital PCR (dPCR), gaining prominence in the 2010s for its absolute quantification achieved by partitioning samples into individual reactions. Distinctively, dPCR excels in detecting rare mutations and analyzing copy number variations with heightened precision for low-abundance targets, eliminating the need for standard curves.

In recent years, the utility of dPCR in clinical labs has surged, driven by its precision, resistance to inhibitors, and lower costs compared to sequencing. The market witnessed a doubling in the availability of commercially accessible dPCR systems, with key players including Bio-Rad Laboratories’ QX systems and Thermo Fisher Scientific’s QuantStudio 3D. The trend revealed an augmentation in optical channels and multiplexing capabilities. Roche entered the clinical space with its Digital LightCycler, focusing on applications in oncology and disease monitoring, featuring high sample input volume and six-color detection.

Qiagen outlined plans for regulatory clearances for its QIAcuity system in clinical dPCR tests, starting with oncology applications. Bio-Rad expanded its digital PCR diagnostics into reproductive health, infectious disease, and transplant monitoring, building on its involvement in clinical in vitro diagnostic testing.

Clinical trials and applications of dPCR witnessed substantial developments, with Geneoscopy achieving positive results in a colorectal cancer trial using Bio-Rad’s QXDx system. Qiagen collaborated with Myriad for companion diagnostic tests, and Enumerix targeted the early non-invasive prenatal testing (NIPT) market, detecting 222 loci in chromosomes 13, 18, and 21 in a single-tube workflow.

The evolution from PCR to qPCR and eventually dPCR has propelled the field of molecular biology into unprecedented precision and versatility. As clinical applications continue to expand and new technologies emerge, digital PCR stands at the forefront, offering a robust platform for researchers and clinicians alike to delve into the intricacies of genetic analysis with unparalleled accuracy. The journey from amplification to quantification reflects not just a technological advancement but a transformative stride towards unlocking the full potential of DNA analysis in diverse scientific endeavors and clinical advancements.