Our tests can help identify patients whose cancer has the right molecular profile for your clinical program, and more easily monitor their response to investigational drugs. Partner with Guardant Health for your prospective patient enrollment, clinical trial matching, and companion diagnostic needs — to accelerate clinical development and bring life saving treatments to patients.
Our Guardant360® liquid biopsy tests accelerate trial enrollment compared to traditional tissue biopsy, providing faster results in approximately 7 days upon sample receipt, instead of weeks. Accessible by trial sites globally, our Investigational Use Only reports can be tailored to your trial’s exact biomarker needs.
Patient enrollment in clinical study (SCRUM-Japan GOZILA) using ctDNA vs. tissue
The SCRUM-Japan GOZILA study demonstrated that Guardant360 shortened screening duration by 67% (median 11 vs. 33 days) and improved trial enrollment rate by 132% (9.5% vs. 4.1%).
Source: Nakamura (Yoshino), et al. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer – SCRUM-Japan GI-SCREEN and GOZILA studies, Nature Medicine. 2020.
Through GuardantConnect™, we can work with you and our ordering physicians to refer patients in real-time with alterations of interest for whom a trial, or newly approved therapies, could be appropriate. Such referrals are made only with physician and patient consent, in a HIPAA-compliant manner.
The program leverages the vast reach of the Guardant360 test within the U.S. to drive awareness of ongoing studies at the point-of-care, to overcome historical challenges associated with biomarker screening.
Expedite your drug development, regulatory, and commercial strategies by collaborating with a trusted partner. Our experience encompasses multiple IDEs, FDA PMA and sPMA submissions, IVDD self-certification and MHLW submissions too. Bring your drug to market faster with our industry-leading liquid biopsy test, available in over 70 countries today.
Guardant360 CDx FDA approvals and programs
Contact our biopharma team to see how we can help you accelerate precision oncology and bring the next generation of cancer therapies to patients sooner.
Address:
21 Biopolis Road,
# 03-28, Nucleos,
Singapore 138567.
Telephone:
+65 6018 8504
WhatsApp Hotline:
+65 8940 0360
Email:
clientservicesamea@guardanthealth.com
biopharma_AMEA@guardanthealth.com
Media inquiries:
Guardant Health Japan Corp.
Address:
9F Tokyo Portcity Takeshiba Office Tower,
1-7-1 Kaigan, Minato-ku,
Tokyo, 105-7590, Japan
© 2023 Guardant Health AMEA ALL RIGHTS RESERVED