FDA Approves Illumina’s TruSight Oncology Comprehensive Assay, Now Offered by PreCheck Health Services as “SolidTumorCheck+” — A Breakthrough in Precision Oncology

MIAMI, Sept. 9, 2024 /PRNewswire/ — The FDA has granted approval on Illumina’s TruSight Oncology Comprehensive Assay, marking a transformative milestone in cancer diagnostics. This innovative in vitro diagnostic (IVD) kit is the first of its kind, offering distributable comprehensive genomic profiling (CGP) with pan-cancer companion diagnostic claims. PreCheck Health Services is excited to introduce this test under the name SolidTumorCheck+, marking the beginning of a new phase in precision oncology and patient care.

With the ability to process the TruSight Oncology Comprehensive assay, PreCheck Health Services can now provide patients with enhanced access to cutting-edge cancer treatments. This advancement enables rapid and detailed genomic profiling, helping clinicians deliver more targeted and personalized treatment strategies.

A Monumental Advancement for Cancer Diagnostics

The FDA’s approval of the TruSight Oncology Comprehensive test marks a significant leap forward for both medical professionals and patients. The test analyzes over 500 gene biomarkers, supporting CGP across multiple cancer types. This detailed molecular profiling provides clinicians with actionable insights to recommend targeted therapeutic options, supported by two companion diagnostic claims.

What is TruSight Oncology Comprehensive?

TruSight Oncology Comprehensive is the first FDA-approved diagnostic kit designed to elevate cancer genomics. By profiling over 500 gene biomarkers, it aids in detecting cancer-driving genetic alterations across a variety of tumor types. Its standout feature is the pan-cancer companion diagnostic capability, which enables personalized therapy recommendations based on a patient’s specific genomic profile.

Key Features and Benefits of SolidTumorCheck+

  1. Comprehensive Genomic Profiling (CGP):
    The SolidTumorCheck+ test provides detailed genomic analysis across a broad spectrum of cancers, offering valuable insights into the molecular mechanisms driving the disease.
  2. 500+ Gene Biomarkers:
    This test detects over 500 gene biomarkers, allowing for a comprehensive and thorough assessment of various tumor types. This in-depth profiling aids in personalized treatment decisions.
  3. Pan-Cancer Companion Diagnostic Claims:
    SolidTumorCheck+ includes pan-cancer companion diagnostics, which further enhance its ability to match patients with specific therapies, providing a tailored approach to cancer treatment.
  4. Expanding Access to Precision Oncology:
    One of the most significant benefits of SolidTumorCheck+ is its potential to expand precision oncology services. By enabling PreCheck Health Services to process the assay locally, patients can receive advanced cancer care without the need to travel to major cancer centers.

Advantages for Clinical Labs:

  • Localized Access to Advanced Diagnostics:

    PreCheck Health Services can now offer highly specialized cancer testing, positioning them as leaders in community-based healthcare.
  • Faster Turnaround Times:

    With the ability to process tests locally, SolidTumorCheck+ reduces the wait time for results, potentially accelerating treatment plans.
  • Enhancing Lab Reputation:

    By offering state-of-the-art genomic profiling, PreCheck Health Services enhances its reputation as a pioneer in cancer diagnostics.

Frequently Asked Questions

  1. How does this test benefit patients?
    SolidTumorCheck+ offers precision medicine, tailoring therapies to each patient’s unique cancer profile. The localized testing ensures faster diagnosis and treatment planning.
  2. Which cancers does the test cover?
    SolidTumorCheck+ is versatile, covering a wide range of cancer types by detecting genetic alterations across various tumors.
  3. How does the pan-cancer companion diagnostic work?
    The pan-cancer companion diagnostic identifies the most effective targeted therapies based on a patient’s specific genetic profile, ensuring a personalized treatment plan.

Conclusion

The FDA approval of TruSight Oncology Comprehensive is a defining moment in the world of cancer diagnostics and precision medicine. By bringing this advanced assay to their patients, PreCheck Health Services is driving progress in cancer care, allowing more patients to access personalized treatment closer to home. With its comprehensive capabilities and pan-cancer companion diagnostic claims, SolidTumorCheck+ is set to revolutionize cancer treatment, providing new hope for improved outcomes.

For PreCheck Health Services, offering this cutting-edge test reinforces its position in the rapidly evolving field of cancer genomics. By processing the FDA-approved SolidTumorCheck+, they not only contribute to vital research but also offer life-changing resources to patients in their communities.

Contact Information
PreCheck Health Services, Inc.

100 Biscayne Blvd, Suite 1611, Miami, FL 33132

www.precheckhealth.com

[email protected] 

+1 (214) 680-5000

SOURCE PreCheck Health Services, Inc.


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