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Clinical Genomics
3 min read

Precision medicine: beyond newborn screening

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Revity, Inc. was established in May 2023 as a science-based company that leverages innovation in life sciences and diagnostics to improve lives globally. Revvity Omics is the company’s genomics services business. The organization builds on its legacy of screening 40 million babies annually across 110 countries for life-threatening diseases and leverages this expertise in the newborn screening ecosystem to provide pharmaceutical companies access to the latest advances in the field of genetics.

Revvity Omics combines this expertise with the force of its parent company, Revvity, Inc., and its proficiency in ideating, developing, and manufacturing instruments and kits. Together, Revvity and Revvity Omics partner with pharmaceutical companies to help with, among other things, phase 3 clinical trials and guide through regulatory approval for companion diagnostics (CDx).

Three steps into the future

The creation of Revvity Omics takes three large steps into the future of genomic medicine:

  • Global footprint
  • Technical skills
  • Esoteric testing

Revvity Omics has built deep relationships around the globe in the US, Europe, China, and India and can leverage Revvity’s cutting-edge instrumentation and reagents to look beyond routine chemistry and identify and document esoteric biochemical and molecular aspects of disease. These technical skills extend to include digital solutions from informatics software solutions and soon, tools from the artificial intelligence (AI) learning space. Revvity Omics’ diversified portfolio of skills helps pharmaceutical companies meet their goals of drug screening and drug development. In the case of pharmaceutical companies who already have an approved drug on the market, Revvity Omics can aid in the development of complementary diagnostic tests and/or biomarker assays, as well as the use of those tests in clinical trials and the identification of patients who could benefit from the drug.

Revvity Omics continues to maintain this leadership role by developing the ability to screen for traditional drugs and enable the development of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-based drugs. This support is necessary because such drugs, while exciting, bring with them new challenges in monitoring safety and efficacy. In recognition of this, Revvity is developing new informatic tools that can be used to monitor CRISPR-based drugs to determine if they are on target and working.

Regulatory support

When looked at from a global perspective, the regulatory landscape has never been so complicated. For example, in May of 2023, the European Commission entered into the application of the new In Vitro Diagnostic Medical Devices Regulation (IVDR), which was designed to prevent disruption in the supply of essential healthcare products. Pharmaceuticals navigating these developments can benefit from Revvity Omics' relationships with regulatory agencies which have been built over decades in the industry into global trusting partnerships. Pharmaceutical companies (large, medium, and small) that engage Revvity Omics have access to a worldwide network that allows them to reach China and India and introduce their drugs into these markets.

Revvity provides reagents, consumables, assays, instruments, and software to customers in markets ranging from pharma and biotech, to diagnostic laboratories, academia, and government agencies. As the service arm of Revvity, Revvity Omics provides quality, regulatory, and clinical support from the discovery phase to drug realization.

Dried blood spot cards

Dried blood spot (DBS) cards serve as an example of how Revvity Omics brings its global footprint, technical skills, and esoteric testing to assays. Newborn screening is fundamentally based on DBS cards so Revvity Omics can leverage its history in that ecosystem and its experience in manufacturing DBS cards to create DBS cards that can be used throughout the entire drug screening cycle and regulatory approval.

DBS cards have many advantages over blood samples when it comes to sampling blood intended for laboratory analysis. They use finger sticks and thus remove the need for a phlebotomist; they enhance the stability of analytes at room temperature; and they simplify the transportation of samples without a cold chain.

This use of a DBS specimen differentiates Revvity Omics from its competitors. That distinction continues to grow more pronounced as Revvity Omics establishes the use of DBS cards not just for biochemical assays, but also for DNA-based assays. DBS cards can be used for the analysis of an entire genome, single genes, or single mutations within a gene. The stability of the sample on the card also means that the sample can travel around the globe, removing the complexity associated with shipping whole urine samples or whole blood samples and providing patients access to tests wherever they may be.

Therapeutic solutions

Revvity Omics works in tandem with Revvity to reach around the globe and within the company to leverage advances in cell and gene therapy to identify therapeutic solutions. Revvity Omics builds and uses these tools from the drug discovery to preclinical and finally to the clinical stage of drug development. This ability to support the entire pipeline of drug development for global patient access is what Revvity means when it says, “We are united in science and united in impact.”

This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.


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