NEW YORK, May 15, 2015 /PRNewswire/ -- A recent U.S. Food and Drug Administration (FDA) advisory committee's vote to recommend approval of a drug that works directly to counteract the genetic defect that causes cystic fibrosis (CF) demonstrates the increasing need for prenatal and newborn genetic testing, according to Kalorama Information. The healthcare market research publisher's report, The Market for Prenatal, Newborn and Carrier Genetic Testing, discusses the technologies and tests used in chromosomal analysis and in the diagnosis of inherited disorders, as well as in the detection of carriers of inherited diseases.
The Market for Prenatal, Newborn and Carrier Genetic Testing can be found at Kalorama Information: http://www.kaloramainformation.com/redirect.asp?progid=87467&productid=8963025.
On May 12, the FDA advisory committee voted 12 to 1 to recommend that the FDA approve the potential ivacaftor/lumacaftor combination drug (Orkambi). The FDA is considering whether to approve Orkambi for people with CF ages 12 and older who have two copies of F508del – the most common mutation in CF patients – which represents 8,500 people or nearly a third of the CF population in the United States. The committee's recommendation is not binding, however. The FDA will make the final decision and has set July 5, 2015, as the target review date.
An inherited condition, cystic fibrosis is a life-threatening disorder that causes severe damage to the lungs and digestive system. The Cystic Fibrosis Foundation reports that each year about 1,000 new cases are diagnosed in the U.S. and that over 75% of people with CF are diagnosed by age 2. Many children born today with cystic fibrosis are identified through newborn screening. In the United States, CF is part of the newborn screening panel in all fifty states, plus the District of Columbia.
Vertex, the maker of Orkambi, is now testing the drug in children as young as 6.
"It is not hard to imagine a future in which such genetic treatments would be applied at an even earlier age; therefore there is an increased need for prenatal and newborn testing," said Bruce Carlson, Publisher of Kalorama Information.
Prenatal, neonatal and carrier testing are competitive testing markets, according to Kalorama. Their report highlights recent activities in the rapidly evolving inherited disease testing market. Leading competitors and product developers are listed in the manufacturer profiles. There are over 55 companies in this market that are profiled by Kalorama, including the following:
- 23andMe, Inc.
- AB SCIEX (A Danaher Corporation Company)
- Abbott Laboratories
- Affymetrix, Inc.
- Agena Bioscience Inc.
- Agilent Technologies Inc.
- Ambry Genetics Corp.
- ARUP Laboratories
- Astra Biotech GmbH
- Asuragen, Inc.
- Athena Diagnostics, Inc. (A Quest Diagnostics Business)
- AutoGenomics, Inc.
- Berry Genomics Co., Ltd.
- Bio-Rad Laboratories, Inc.
- Bio-Reference Laboratories, Inc. (BRLI)
- Centogene AG
- Chromsystems Instruments & Chemicals GmbH
- Claritas Genomics, Inc.
- Color Genomics, Inc.
- CombiMatrix Corporation
- Counsyl, Inc.
- Courtagen Life Sciences, Inc.
- Gene by Gene, Ltd.
- Genection, Inc. (An Invivoscribe Company)
- GenePeeks, Inc.
- Genesis Genetics
- Genetadi Biotech S.L.
- Genetic Technologies Limited / Phenogen Sciences, Inc. (U.S. Division)
- GenMark Diagnostics, Inc.
- Genoma Group
- Genomed AG
- GenPath / GenPath Women's Health
- Good Start Genetics, Inc.
- Hologic, Inc.
- Illumina, Inc.
- Innovations Exchange Pte Ltd (INEX) and iGene™ Diagnostics Pte Ltd (an INEX Company)
- Invitae Corporation
- Laboratory Corporation of America (LabCorp) Integrated Genetics
- Life Technologies Corporation (Acquired by Thermo Fischer Scientific Inc.)
- LifeCodexx AG (Subsidiary of GATC Biotech AG)
- Multiplicom NV
- Myriad Genetics, Inc.
- Natera, Inc.
- NewGene Ltd.
- NIPD Genetics, Ltd.
- Oxford Gene Technology
- Parabase Genomics
- Pathway Genomics Corporation
- PerkinElmer, Inc.
- Premaitha Health
- Progenity, Inc.
- QIAGEN N.V.
- Quest Diagnostics
- Recombine, Inc.
- Reproductive Genetics Institute
- Sebia, Inc.
- Sequenom, Inc.
- Sophia Genetics
- SpOtOn Clinical Diagnostics Limited
- SynapDx Corporation
- Transgenomic, Inc.
The Market for Prenatal, Newborn and Carrier Genetic Testing discusses the growing global genetic testing laboratory services market, including:
- carrier testing
- prenatal testing
- newborn screening
- neonatal/pediatric testing
- testing for adult onset genetic disorders
The healthcare market researcher's report provides the world markets for prenatal, newborn, postnatal, and carrier genetic testing for 2014 to 2019. In addition, company revenues are provided for the previous three years. Further, this report includes financial information on deals involving companies in the molecular diagnostic inherited disease/prenatal testing field, summarized within report tables. The report can be found at Kalorama Information: http://www.kaloramainformation.com/redirect.asp?progid=87467&productid=8963025.
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.
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SOURCE Kalorama Information