Post by icemandios on Jan 4, 2017 16:57:10 GMT
Natera Files Suit Against Bio-Reference Laboratories for Breach of Contract
Jan 04, 2017
| staff reporter
NEW YORK (GenomeWeb) – Natera has filed a suit against Bio-Reference Laboratories claiming that the firm breached a contract with Natera when it launched and promoted a noninvasive prenatal test based on Illumina's technology.
Bio-Reference has been offering Natera's Panorama noninvasive prenatal screening test since 2013, but last month it launched its own NIPS, ClariTest, which is based on technology it licensed from Illumina.
Natera alleges in its suit, which was filed with the US District Court for the Southern District of New York, that Bio-Reference's promotional materials for ClariTest violate the licensing agreement between Bio-Reference and Natera. It further alleged that the marketing materials for ClariTest discuss ClariTest more prominently than Panorama, "make comparisons that are not supported by peer-reviewed publications," and "disparage" Panorama.
In 2015, Natera and Bio-Reference updated their licensing agreement. According to the suit, Natera granted Bio-Reference a license to develop its own NIPS, and although it did not prohibit Bio-Reference from distributing tests developed by third parties, it placed restrictions on marketing. Specifically, Natera said that Bio-Reference was bound to promote Panorama as prominently as third-party tests and must base any claims or comparisons on data from peer-reviewed publications.
In addition, Natera said that it shared confidential information with Bio-Reference that Bio-Reference subsequently used to market ClariTest, including strategies for selling, costs of goods sold, and proposals to improve reimbursement. Natera said it also shared confidential information related to its cancer diagnostics product pipeline based on assertions from Bio-Reference that it was interested in partnering with Natera on those products.
Natera requested a preliminary injunction and a temporary restraining order against Bio-Reference and ClariTest. Although US District Judge Ronnie Andrews denied the temporary restraining order, writing that Natera did not demonstrate that it would suffer "irreparable harm through the loss of trade secrets," the motion for a preliminary injunction will be heard.
_______________________________________________
Previously:
Westlaw News | Tue Dec 13, 2016 | 6:43am EST
Natera loses bid to block rival prenatal testing product
And in today's news:
Leading Genetic Testing Companies Join Forces to Launch the Coalition for Access to Prenatal Screening
Coalition aims to make noninvasive prenatal testing easily accessible to all pregnant women
News provided by
Coalition for Access to Prenatal Screening (CAPS)
Jan 04, 2017, 10:22 ET
Share this article
WASHINGTON, Jan. 4, 2017 /PRNewswire/ -- Today, five leading genetic testing companies in the U.S. are coming together to launch the Coalition for Access to Prenatal Screening (CAPS). This new organization will work to improve access to state-of-the-art prenatal screening using cell-free DNA (cfDNA)-based noninvasive prenatal testing (NIPT). The coalition is comprised of: Illumina, Inc. (NASDAQ: ILMN); Counsyl, Inc.; Progenity, Inc.; Natera, Inc. (NASDAQ: NTRA); and Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) through its Integrated Genetics specialty laboratory.
CAPS and its member companies are working together to promote public awareness about the value of cfDNA-based NIPT and to advocate for the highest standards of quality, service and education. CAPS will work to encourage appropriate legislative measures and reimbursement coverage policy changes for this medically actionable testing service, which has the potential to improve personalized patient care.
NIPT represents a major advance in the screening for fetal chromosomal aneuploidies through the analysis of millions of cfDNA fragments in the blood of a pregnant woman. Chromosomal aneuploidies are characterized by an abnormal number of chromosomes, which may cause genetic disorders in a newborn baby, including some birth defects. Prenatal screening for chromosomal aneuploidies using analysis of serum proteins has been the standard of care for decades. However, cfDNA-based NIPT is becoming the preferred method of prenatal screening for many healthcare providers and patients since its introduction to clinical practice in 2011.
The high sensitivity and specificity, and low failure rate, of cfDNA-based NIPT result in fewer women undergoing invasive testing procedures. Although all positive prenatal screening results should be confirmed with diagnostic testing by chorionic villus sampling (CVS) or amniocentesis, cfDNA-based NIPT correctly identifies a higher proportion of pregnancies affected by chromosomal aneuploidies, including Trisomy 21/Down syndrome, Trisomy 18/Edwards syndrome, and Trisomy 13/Patau syndrome, compared to serum protein based screening options.
Extensive data have been published in peer-reviewed literature that establish the performance of cfDNA-based NIPT as a powerful screening tool for fetal chromosomal aneuploidies.1-5 In addition to having a significantly higher detection rate, cfDNA-based NIPT can simultaneously test for a larger number of specific chromosomal aneuploidies than traditional serum screening methods. Furthermore, the markedly lower false positive rates of cfDNA-based NIPT provide significantly improved positive predictive values compared to traditional screening tests.5 NIPT can be used as early as 9 to 10 weeks into the pregnancy.
Numerous professional organizations, including the American Congress of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), the International Society for Prenatal Diagnosis (ISPD), the American College of Medical Genetics and Genomics (ACMG), and the National Society of Genetic Counselors (NSGC) have recognized cfDNA-based NIPT as a screening option for all pregnancies, given appropriate patient counseling regarding the performance, risks and benefits of such testing.
"As leading providers of cfDNA-based NIPT, CAPS members are working together towards the common goal of ensuring that this innovative and highly accurate screening method is easily accessible to all pregnant women who choose to pursue aneuploidy screening, regardless of their risk factors, income, age or geographic location," said Arnold W. Cohen, M.D., Chairman Emeritus of the Department of Obstetrics and Gynecology at the Einstein Healthcare Network, and Chairman of the CAPS Clinical Advisory Board. "We recognize the importance of providing reliable and useful information about cfDNA-based NIPT to patients, healthcare providers, and public and private insurers."
CAPS is assembling a clinical advisory board under the leadership of Dr. Cohen, which will provide an independent medical perspective. The composition of the board will be announced during the first half of 2017.
Jan 04, 2017
| staff reporter
NEW YORK (GenomeWeb) – Natera has filed a suit against Bio-Reference Laboratories claiming that the firm breached a contract with Natera when it launched and promoted a noninvasive prenatal test based on Illumina's technology.
Bio-Reference has been offering Natera's Panorama noninvasive prenatal screening test since 2013, but last month it launched its own NIPS, ClariTest, which is based on technology it licensed from Illumina.
Natera alleges in its suit, which was filed with the US District Court for the Southern District of New York, that Bio-Reference's promotional materials for ClariTest violate the licensing agreement between Bio-Reference and Natera. It further alleged that the marketing materials for ClariTest discuss ClariTest more prominently than Panorama, "make comparisons that are not supported by peer-reviewed publications," and "disparage" Panorama.
In 2015, Natera and Bio-Reference updated their licensing agreement. According to the suit, Natera granted Bio-Reference a license to develop its own NIPS, and although it did not prohibit Bio-Reference from distributing tests developed by third parties, it placed restrictions on marketing. Specifically, Natera said that Bio-Reference was bound to promote Panorama as prominently as third-party tests and must base any claims or comparisons on data from peer-reviewed publications.
In addition, Natera said that it shared confidential information with Bio-Reference that Bio-Reference subsequently used to market ClariTest, including strategies for selling, costs of goods sold, and proposals to improve reimbursement. Natera said it also shared confidential information related to its cancer diagnostics product pipeline based on assertions from Bio-Reference that it was interested in partnering with Natera on those products.
Natera requested a preliminary injunction and a temporary restraining order against Bio-Reference and ClariTest. Although US District Judge Ronnie Andrews denied the temporary restraining order, writing that Natera did not demonstrate that it would suffer "irreparable harm through the loss of trade secrets," the motion for a preliminary injunction will be heard.
_______________________________________________
Previously:
Westlaw News | Tue Dec 13, 2016 | 6:43am EST
Natera loses bid to block rival prenatal testing product
And in today's news:
Leading Genetic Testing Companies Join Forces to Launch the Coalition for Access to Prenatal Screening
Coalition aims to make noninvasive prenatal testing easily accessible to all pregnant women
News provided by
Coalition for Access to Prenatal Screening (CAPS)
Jan 04, 2017, 10:22 ET
Share this article
WASHINGTON, Jan. 4, 2017 /PRNewswire/ -- Today, five leading genetic testing companies in the U.S. are coming together to launch the Coalition for Access to Prenatal Screening (CAPS). This new organization will work to improve access to state-of-the-art prenatal screening using cell-free DNA (cfDNA)-based noninvasive prenatal testing (NIPT). The coalition is comprised of: Illumina, Inc. (NASDAQ: ILMN); Counsyl, Inc.; Progenity, Inc.; Natera, Inc. (NASDAQ: NTRA); and Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) through its Integrated Genetics specialty laboratory.
CAPS and its member companies are working together to promote public awareness about the value of cfDNA-based NIPT and to advocate for the highest standards of quality, service and education. CAPS will work to encourage appropriate legislative measures and reimbursement coverage policy changes for this medically actionable testing service, which has the potential to improve personalized patient care.
NIPT represents a major advance in the screening for fetal chromosomal aneuploidies through the analysis of millions of cfDNA fragments in the blood of a pregnant woman. Chromosomal aneuploidies are characterized by an abnormal number of chromosomes, which may cause genetic disorders in a newborn baby, including some birth defects. Prenatal screening for chromosomal aneuploidies using analysis of serum proteins has been the standard of care for decades. However, cfDNA-based NIPT is becoming the preferred method of prenatal screening for many healthcare providers and patients since its introduction to clinical practice in 2011.
The high sensitivity and specificity, and low failure rate, of cfDNA-based NIPT result in fewer women undergoing invasive testing procedures. Although all positive prenatal screening results should be confirmed with diagnostic testing by chorionic villus sampling (CVS) or amniocentesis, cfDNA-based NIPT correctly identifies a higher proportion of pregnancies affected by chromosomal aneuploidies, including Trisomy 21/Down syndrome, Trisomy 18/Edwards syndrome, and Trisomy 13/Patau syndrome, compared to serum protein based screening options.
Extensive data have been published in peer-reviewed literature that establish the performance of cfDNA-based NIPT as a powerful screening tool for fetal chromosomal aneuploidies.1-5 In addition to having a significantly higher detection rate, cfDNA-based NIPT can simultaneously test for a larger number of specific chromosomal aneuploidies than traditional serum screening methods. Furthermore, the markedly lower false positive rates of cfDNA-based NIPT provide significantly improved positive predictive values compared to traditional screening tests.5 NIPT can be used as early as 9 to 10 weeks into the pregnancy.
Numerous professional organizations, including the American Congress of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), the International Society for Prenatal Diagnosis (ISPD), the American College of Medical Genetics and Genomics (ACMG), and the National Society of Genetic Counselors (NSGC) have recognized cfDNA-based NIPT as a screening option for all pregnancies, given appropriate patient counseling regarding the performance, risks and benefits of such testing.
"As leading providers of cfDNA-based NIPT, CAPS members are working together towards the common goal of ensuring that this innovative and highly accurate screening method is easily accessible to all pregnant women who choose to pursue aneuploidy screening, regardless of their risk factors, income, age or geographic location," said Arnold W. Cohen, M.D., Chairman Emeritus of the Department of Obstetrics and Gynecology at the Einstein Healthcare Network, and Chairman of the CAPS Clinical Advisory Board. "We recognize the importance of providing reliable and useful information about cfDNA-based NIPT to patients, healthcare providers, and public and private insurers."
CAPS is assembling a clinical advisory board under the leadership of Dr. Cohen, which will provide an independent medical perspective. The composition of the board will be announced during the first half of 2017.
