GeneDx de OPKO Health suma a GenomeXpress a su cartera de genómica clínica líder en la industria

GenomeXpress is a rapid genome sequencing test, reporting results within approximately seven days

GAITHERSBURG, Md., 6 ago 2020 /PRNewswire/ — GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the launch of GenomeXpress, a rapid genome sequencing test. Verbal GenomeXpress results of pathogenic and/or likely pathogenic variants in known disease causing genes are delivered to the ordering healthcare provider within approximately seven days after the start of testing. A written report for all confirmed variants is sent to the provider within approximately 14 days after start of testing. With the addition of GenomeXpress, GeneDx expands its industry-leading clinical genomics portfolio to now include three rapid sequencing options.

Genome sequencing is a test used to identify variations in any part of the genome and is an important tool for diagnosing genetic diseases. By including both protein-coding and non-coding regions of the human genome including promoter, intronic, and untranslated regions, GenomeXpress allows for the detection of characterized/pathogenic variants in regions that are not assessed by exome sequencing. Genetic changes can cause over 13,000 different diseases and patients often present with overlapping symptoms.1 Finding the correct diagnosis is not always straight-forward and may require multiple tests, costly evaluations, invasive procedures and long hospital stays. A rapid diagnosis can alter management, shorten the length of hospital stays, reduce healthcare costs and save lives. 

“With the new offering of GenomeXpress, we are advancing healthcare,” said Jane Juusola, Ph.D., FACMG, Director of Clinical Genomics for GeneDx. “Rapid genome sequencing paired with GeneDx’s massive and ever-expanding genomic database provides clinicians, patients and their families with more meaningful information. As our database grows, we are better able to distinguish likely pathogenic variants from likely benign variants and subsequently identify new disease-causing genes. Every patient who receives a GenomeXpress test will benefit from both our current and future knowledge of genetic disease.”

“New and emerging scientific understanding is an imperative aspect of genomics,” said Adam Logal, President of GeneDx and Chief Financial Officer of OPKO Health. “Leveraging GeneDx’s diverse database with a rapid genome sequencing test may provide patients and their families with options they did not have before. GenomeXpress utilizes GeneDx’s clinical genomics expertise, laboratory excellence and the limitless value of the genome, as a future-facing sequencing technology.”

Genome sequencing has a diagnostic utility of 42-73%1-6 with a higher yield for cases that specifically include other family members.2,5,7-11 With a clinical utility of greater than four times that of chromosomal microarray, genome sequencing should be considered a first-line genomics test for children with suspected genetic diseases.2

About GeneDx, Inc.
GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

Acerca de OPKO Health
OPKO es una compañía biofarmacéutica y de diagnóstico multinacional que busca posicionarse como líder de la industria en grandes mercados de rápido crecimiento, a través de sus tecnologías exclusivas y su experiencia e innovación en el descubrimiento, el desarrollo y la comercialización. Para obtener más información, visite www.opko.com.

Advertencia respecto de declaraciones con perspectivas de futuro
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding BioReference’s testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity, our ability to increase COVID 19 testing availability nationwide, as well as the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Muchos factores podrían hacer que nuestras actividades o resultados reales difieran sustancialmente de las actividades y resultados anticipados en las declaraciones con perspectivas de futuro. Estos factores incluyen aquellos descritos en los informes anuales de OPKO Health, Inc. los informes anuales del formulario 10-K de OPKO Health, Inc. presentados y a presentarse ante la Comisión de Bolsa y Valores y en otras presentaciones nuestras ante la Comisión de Bolsa y Valores. Además, las declaraciones con perspectivas de futuro también pueden verse afectadas de manera adversa por escasez de equipos y reactivos, factores generales del mercado, desarrollo de productos de la competencia, disponibilidad de productos, normas y leyes federales y estatales, el proceso regulatorio de nuevos productos e indicaciones, problemas de fabricación que puedan surgir, posiciones de patentes y litigios, entre otros factores. Las proyecciones que contiene este comunicado de prensa solo expresan la situación a la fecha en que se realizaron, y no asumimos obligación alguna de actualizar las proyecciones. Tenemos la intención de que todas las declaraciones con perspectivas de futuro estén sujetas a las disposiciones de puerto seguro de la ley PSLRA.

Referencias:

  1. Clark et al., 2019
  2. Clark et al., 2018
  3. Soden et al. 2014
  4. Rady Children’s Hospital-San Diego (2020). Project Baby Bear Final Report
  5. Petrikin et al., 2018
  6. Gilissen et al. 2014
  7. Bick et al., 2017
  8. Willig et al., 2015
  9. Farnaes et al., 2018
  10. Kingsmore et al., 2019
  11. Scocchia et al., 2019

SOURCE GeneDx, Inc.

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