Non-Invasive Prenatal Testing (NIPT) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Non-invasive prenatal screening is a method that determines the risk of genetic abnormalities in the fetus. The Non-invasive prenatal testing (NIPT) pipeline market research report provides comprehensive information about the Non-invasive prenatal testing (NIPT) pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Territory Outlook of the NIPT Pipeline Products Market

The US, Europe, Canada, India, Singapore, and the UK have products in the NIPT pipeline product market. As of July 2022, the US has the highest number of products in the pipeline out of them all.

NIPT Pipeline Products Market, by Territory

NIPT Pipeline Products Market, by Territory

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Key Regulatory Paths for the NIPT Pipeline Products Market

The regulatory paths followed by the NIPT pipeline products are 510(k), CE-IVD, CLIA, HSA, ICAC, MDL, PMA, and UKCA. Most of the products follow the 510(k) pathway to enter the market.

NIPT Pipeline Products Market, by Regulatory Path

NIPT Pipeline Products Market, by Regulatory Path

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Key Companies in the NIPT Pipeline Products Market

Some of the key companies in the NIPT pipeline products market are Agena Bioscience Inc, Amity University, BCML GmbH, BioCeps (Inactive), Biocept Inc, Biofidelity Ltd, BioFluidica Microtechnologies LLC, Cardiff Oncology Inc, Celula Inc, and ChromaCode Inc.

Agena Bioscience Inc

Agena Bioscience Inc operates as a medical device company. The company products are used for genotyping and mutation detection, ultrasensitive detection, methylation analysis, oncology, and other applications. Agena Bioscience is headquartered in San Diego, California, the US.

Amity University

Amity University is an educational institution that undertakes various national and international research activities. The institution has global campuses in London, Dubai, New York, Singapore, Mauritius, Seattle, Abu Dhabi, South Africa, San Francisco, Romania, China, and Amsterdam. Amity is headquartered in Noida, India.

Biocept Inc

Biocept Inc is a molecular diagnostics company. They develop and commercialize proprietary circulating tumor cell (CTC) and circulating tumor DNA assays utilizing a standard blood sample. They also serve cancer diagnostic assays to oncologists and other physicians, hospitals, and cancer centers. Biocept is headquartered in San Diego, California, the US.

Biofidelity Ltd

Biofidelity Ltd. is a molecular assay company that develops molecular diagnostic assay that enables the rapid detection of target DNA sequences. The company is headquartered in the UK.

Cardiff Oncology Inc

Cardiff Oncology Inc is a clinical-stage biotechnology company that focuses on developing drugs that target cell division using precision cancer medicine (PCM) approach for the treatment of hematologic and solid tumor cancers. Cardiff Oncology is headquartered in San Diego, California, the US.

Market Report Overview

Key Territories The US, Europe, Canada, India, Singapore, and The UK
Key Regulatory Paths 510(k), CE-IVD, CLIA, HSA, ICAC, MDL, PMA, and UKCA
Key Companies Agena Bioscience Inc, Amity University, BCML GmbH, BioCeps (Inactive), Biocept Inc, Biofidelity Ltd, BioFluidica Microtechnologies LLC, Cardiff Oncology Inc, Celula Inc, and ChromaCode Inc

Scope

This report provides:

  • Extensive coverage of the Non-Invasive Prenatal Testing (NIPT) under development.
  • Details of major pipeline products which include product description, licensing, collaboration details, and other developmental activities.
  • Reviews of the major players involved in the development of Non-Invasive Prenatal Testing (NIPT) and lists all their pipeline projects.
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage.
  • Key clinical trial data of ongoing trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with a potentially strong product portfolio and create effective counterstrategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Non-Invasive Prenatal Testing (NIPT) under development.
  • Develop market entry and market expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Agena Bioscience Inc
Amity University
BCML GmbH
BioCeps (Inactive)
Biocept Inc
Biofidelity Ltd
BioFluidica Microtechnologies LLC
Cardiff Oncology Inc
Celula Inc
ChromaCode Inc
Echelon Diagnostics Inc
Elysium Health Inc
Fluxion Biosciences Inc
Helicos BioSciences Corporation
Illumina Inc
INEX Innovate Pte Ltd
Johns Hopkins University
Juno Diagnostics Inc
KellBenx Inc (Inactive)
Laval University
Maastricht University Medical Center
Natera Inc
Oxford Gene Technology Ltd
PerkinElmer Inc
Sequenom Inc
Standard BioTools Inc
StellarGene Technologies Pvt Ltd
The Chaim Sheba Medical Center
The Chinese University of Hong Kong
thromboDx BV
Tufts Medical Center
University of Oxford

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 5

|1.2 List of Figures 8

2 Introduction 9

2.1 Non-invasive prenatal testing (NIPT) Overview 9

3 Products under Development 10

3.1 Non-invasive prenatal testing (NIPT) – Pipeline Products by Stage of Development 10

3.2 Non-invasive prenatal testing (NIPT) – Pipeline Products by Territory 11

3.3 Non-invasive prenatal testing (NIPT) – Pipeline Products by Regulatory Path 12

3.4 Non-invasive prenatal testing (NIPT) – Pipeline Products by Estimated Approval Date 13

3.5 Non-invasive prenatal testing (NIPT) – Ongoing Clinical Trials 14

4 Non-invasive prenatal testing (NIPT) – Pipeline Products under Development by Companies 15

4.1 Non-invasive prenatal testing (NIPT) Companies – Pipeline Products by Stage of Development 15

4.2 Non-invasive prenatal testing (NIPT) – Pipeline Products by Stage of Development 17

5 Non-invasive prenatal testing (NIPT) Companies and Product Overview 18

5.1 Agena Bioscience Inc Company Overview 18

5.1.1 Agena Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Amity University Company Overview 19

5.2.1 Amity University Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 BCML GmbH Company Overview 20

5.3.1 BCML GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 BioCeps (Inactive) Company Overview 21

5.4.1 BioCeps (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 Biocept Inc Company Overview 22

5.5.1 Biocept Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.6 Biofidelity Ltd Company Overview 23

5.6.1 Biofidelity Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

5.7 BioFluidica Microtechnologies LLC Company Overview 24

5.7.1 BioFluidica Microtechnologies LLC Pipeline Products & Ongoing Clinical Trials Overview 24

5.8 Cardiff Oncology Inc Company Overview 25

5.8.1 Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.9 Celula Inc Company Overview 26

5.9.1 Celula Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.10 ChromaCode Inc Company Overview 27

5.10.1 ChromaCode Inc Pipeline Products & Ongoing Clinical Trials Overview 27

5.11 Echelon Diagnostics Inc Company Overview 28

5.11.1 Echelon Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.12 Elysium Health Inc Company Overview 29

5.12.1 Elysium Health Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.13 Fluxion Biosciences Inc Company Overview 30

5.13.1 Fluxion Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.14 Helicos BioSciences Corporation Company Overview 31

5.14.1 Helicos BioSciences Corporation Pipeline Products & Ongoing Clinical Trials Overview 31

5.15 Illumina Inc Company Overview 32

5.15.1 Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.16 INEX Innovate Pte Ltd Company Overview 33

5.16.1 INEX Innovate Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.17 Johns Hopkins University Company Overview 34

5.17.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 34

5.18 Juno Diagnostics Inc Company Overview 35

5.18.1 Juno Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.19 KellBenx Inc (Inactive) Company Overview 36

5.19.1 KellBenx Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 36

5.20 Laval University Company Overview 37

5.20.1 Laval University Pipeline Products & Ongoing Clinical Trials Overview 37

5.21 Maastricht University Medical Center Company Overview 40

5.21.1 Maastricht University Medical Center Pipeline Products & Ongoing Clinical Trials Overview 40

5.22 Natera Inc Company Overview 41

5.22.1 Natera Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.23 Oxford Gene Technology Ltd Company Overview 42

5.23.1 Oxford Gene Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.24 PerkinElmer Inc Company Overview 43

5.24.1 PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.25 Sequenom Inc Company Overview 44

5.25.1 Sequenom Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.26 Standard BioTools Inc Company Overview 45

5.26.1 Standard BioTools Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.27 StellarGene Technologies Pvt Ltd Company Overview 46

5.27.1 StellarGene Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.28 The Chaim Sheba Medical Center Company Overview 47

5.28.1 The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 47

5.29 The Chinese University of Hong Kong Company Overview 48

5.29.1 The Chinese University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 48

5.30 thromboDx BV Company Overview 51

5.30.1 thromboDx BV Pipeline Products & Ongoing Clinical Trials Overview 51

5.31 Tufts Medical Center Company Overview 52

5.31.1 Tufts Medical Center Pipeline Products & Ongoing Clinical Trials Overview 52

5.32 University of Oxford Company Overview 53

5.32.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 53

6 Appendix 54

6.1 Methodology 54

6.2 About GlobalData 57

6.3 Contact Us 57

6.4 Disclaimer 57

Table

Non-invasive prenatal testing (NIPT) – Pipeline Products by Stage of Development 10

Non-invasive prenatal testing (NIPT) – Pipeline Products by Territory 11

Non-invasive prenatal testing (NIPT) – Pipeline Products by Regulatory Path 12

Non-invasive prenatal testing (NIPT) – Pipeline Products by Estimated Approval Date 13

Non-invasive prenatal testing (NIPT) – Ongoing Clinical Trials 14

Non-invasive prenatal testing (NIPT) Companies – Pipeline Products by Stage of Development 15

Non-invasive prenatal testing (NIPT) – Pipeline Products by Stage of Development 17

Agena Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Sensigene Trisomy 21 Laboratory Developed Test – Product Status 18

Sensigene Trisomy 21 Laboratory Developed Test – Product Description 18

Amity University Pipeline Products & Ongoing Clinical Trials Overview 19

Prenatal Screening Kit – Product Status 19

Prenatal Screening Kit – Product Description 19

BCML GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

Prenatal Diagnosis Biochip – Product Status 20

Prenatal Diagnosis Biochip – Product Description 20

BioCeps (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 21

Prenatal Diagnostic Test – Product Status 21

Prenatal Diagnostic Test – Product Description 21

Biocept Inc Pipeline Products & Ongoing Clinical Trials Overview 22

preCEED – Product Status 22

preCEED – Product Description 22

Biofidelity Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Molecular Diagnostic Assay – Pre-natal Testing Panel – Product Status 23

Molecular Diagnostic Assay – Pre-natal Testing Panel – Product Description 23

BioFluidica Microtechnologies LLC Pipeline Products & Ongoing Clinical Trials Overview 24

Non-Invasive Prenatal Test – Product Status 24

Non-Invasive Prenatal Test – Product Description 24

Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Non Invasive Prenatal Screening Test – Product Status 25

Non Invasive Prenatal Screening Test – Product Description 25

Celula Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Non-Invasive Pre-Natal Test – Product Status 26

Non-Invasive Pre-Natal Test – Product Description 26

ChromaCode Inc Pipeline Products & Ongoing Clinical Trials Overview 27

HDPCR Non-Invasive Prenatal Testing (NIPT) Panel – Product Status 27

HDPCR Non-Invasive Prenatal Testing (NIPT) Panel – Product Description 27

Echelon Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

PrenatalDx – Product Status 28

PrenatalDx – Product Description 28

Elysium Health Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Non-Invasive Test – Neurodevelopmental Delay – Product Status 29

Non-Invasive Test – Neurodevelopmental Delay – Product Description 29

Fluxion Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Spotlight NIPT – Product Status 30

Spotlight NIPT – Product Description 30

Helicos BioSciences Corporation Pipeline Products & Ongoing Clinical Trials Overview 31

Prenatal Diagnostic Test – Product Status 31

Prenatal Diagnostic Test – Product Description 31

Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Verifi Prenatal Test – Product Status 32

Verifi Prenatal Test – Product Description 32

INEX Innovate Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Lexi – Product Status 33

Lexi – Product Description 33

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 34

Prenatal Diagnostic Test – Product Status 34

Prenatal Diagnostic Test – Product Description 34

Juno Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Noninvasive Prenatal Test – Product Status 35

Noninvasive Prenatal Test – Product Description 35

KellBenx Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 36

KellBenx Prenatal Diagnostic Test – Product Status 36

KellBenx Prenatal Diagnostic Test – Product Description 36

Laval University Pipeline Products & Ongoing Clinical Trials Overview 37

Trisomy 21 Blood Test – Product Status 37

Trisomy 21 Blood Test – Product Description 37

Laval University – Ongoing Clinical Trials Overview 38

Trisomy 21 Blood Test – Personalized Genomics for Prenatal Abnormalities Screening Using Maternal Blood : Towards First Tier Screening and Beyond 39

Maastricht University Medical Center Pipeline Products & Ongoing Clinical Trials Overview 40

MLPA Test – Product Status 40

MLPA Test – Product Description 40

Natera Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Panorama Non-Invasive Prenatal Expanded Test – Product Status 41

Panorama Non-Invasive Prenatal Expanded Test – Product Description 41

Oxford Gene Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

Non-Invasive Prenatal Test – Down’s Syndrome – Product Status 42

Non-Invasive Prenatal Test – Down’s Syndrome – Product Description 42

PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Diagnostic Test – Preterm Birth – Product Status 43

Diagnostic Test – Preterm Birth – Product Description 43

Sequenom Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Next Generation Noninvasive Prenatal Test (NIPT) – Product Status 44

Next Generation Noninvasive Prenatal Test (NIPT) – Product Description 44

Standard BioTools Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Non-Invasive Prenatal Diagnostic Test – Fetal Aneuploidies – Product Status 45

Non-Invasive Prenatal Diagnostic Test – Fetal Aneuploidies – Product Description 45

StellarGene Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Non-Invasive Prenatal Test – Product Status 46

Non-Invasive Prenatal Test – Product Description 46

The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 47

Non-Invasive Prenatal Diagnostic Assay – Product Status 47

Non-Invasive Prenatal Diagnostic Assay – Product Description 47

The Chinese University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 48

Biomarker Assay – Prenatal Diagnosis – Product Status 48

Biomarker Assay – Prenatal Diagnosis – Product Description 48

Biomarker Test – Early Human Birth – Product Status 49

Biomarker Test – Early Human Birth – Product Description 49

mRNA based Prenatal Diagnostic Kit – Product Status 49

mRNA based Prenatal Diagnostic Kit – Product Description 50

thromboDx BV Pipeline Products & Ongoing Clinical Trials Overview 51

Prenatal Screening Test – Product Status 51

Prenatal Screening Test – Product Description 51

Tufts Medical Center Pipeline Products & Ongoing Clinical Trials Overview 52

NPY2R Saliva Test – Product Status 52

NPY2R Saliva Test – Product Description 52

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 53

Prenatal Diagnostic Test – Sickle-Cell Disease – Product Status 53

Prenatal Diagnostic Test – Sickle-Cell Disease – Product Description 53

Glossary 56

Figures

Non-invasive prenatal testing (NIPT) – Pipeline Products by Stage of Development 10

Non-invasive prenatal testing (NIPT) – Pipeline Products by Territory 11

Non-invasive prenatal testing (NIPT) – Pipeline Products by Regulatory Path 12

Non-invasive prenatal testing (NIPT) – Pipeline Products by Estimated Approval Date 13

Non-invasive prenatal testing (NIPT) – Ongoing Clinical Trials 14

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