Guardant Health, Inc. - GH STOCK NEWS

Guardant Health (Nasdaq: GH) is set to ring the Nasdaq opening bell on August 28, 2024, celebrating the launch of their Shield™ blood test for colorectal cancer screening. This FDA-approved test offers a more comfortable alternative for early cancer detection, potentially improving survival rates.

The event marks nearly six years since Guardant's IPO bell-ringing. Co-CEO AmirAli Talasaz emphasized the significance of this milestone for the company, liquid biopsy field, and patients. The ceremony will be broadcast live at 8:30 a.m. Eastern Time, followed by a Behind the Bell interview with management.

Guardant's team will be available in New York City on August 28-29 for media interviews and investor meetings, highlighting the company's commitment to advancing precision oncology.

Guardant Health, a leader in precision oncology, announced participation in key investor conferences. The company will be present at the Canaccord Genuity 44th Annual Growth Conference in Boston, MA, with a fireside chat scheduled on Tuesday, August 13 at 10:30 a.m. ET. Additionally, Guardant Health will partake in a panel discussion on the Future of Cancer Screening at the UBS Genomic Medicine Summit in Dana Point, CA, on Wednesday, August 14 at 2:45 p.m. PT.

Live and archived webcasts of these sessions will be available on the “Investors” section of the Guardant Health website. Further details can be accessed at: www.guardanthealth.com.

Guardant Health (Nasdaq: GH) reported strong Q2 2024 financial results, with revenue increasing 29% to $177.2 million. The company raised its 2024 revenue guidance to $690-$700 million, representing 22-24% growth. Key highlights include:

1. Clinical testing volume up 14% and biopharma testing volume up 56% year-over-year
2. FDA approval of Shield as a first-line colorectal cancer screening option
3. Launch of upgraded Guardant360 on Smart Liquid Biopsy platform
4. Gross profit increased to $104.8 million, with a 59% gross margin
5. Net loss of $102.6 million, or $0.84 per share

The company's strong performance was driven by solid volume growth and improved reimbursement for Guardant360 tests.

Guardant Health (Nasdaq: GH) announced the publication of the COSMOS study in Clinical Cancer Research, validating the utility of its Guardant Reveal™ liquid biopsy test for predicting colorectal cancer recurrence. The study, involving 342 patients with stage I-III resected CRC, demonstrated:

- 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer
- 98% specificity in samples from patients without recurrence
- 100% patient evaluation without tissue testing
- 5.3-month median lead time from ctDNA detection to recurrence

The study supports the use of Guardant Reveal for informing adjuvant therapy decisions and earlier recurrence detection in stage II or III colon cancer patients.

Guardant Health (Nasdaq: GH) has announced the commercial availability of its FDA-approved Shield™ blood test in the U.S. as a primary screening option for colorectal cancer (CRC). The test is now covered by Medicare for eligible beneficiaries once every three years. Shield is the first FDA-approved blood test for primary CRC screening, offering a convenient alternative to traditional methods.

Key points:

• 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia
• >90% patient adherence rate
• Outperforms stool-based tests in life years gained and CRC cases averted
• Results available in about two weeks

The launch represents a significant opportunity for Guardant Health and a major step in the fight against colorectal cancer.

Guardant Health (Nasdaq: GH) announced the acceptance of its CAN-SCREEN model for publication in the Journal of Medical Economics. This health outcomes study emphasizes the importance of combining effective screening performance with high patient adherence in colorectal cancer (CRC) screening to optimize health outcomes. Unlike existing models, CAN-SCREEN accounts for both clinical efficacy and real-world adherence in predicting CRC incidence and mortality rates.

The study highlights the potential of Guardant Health's blood-based screening test, Shield™, to reduce CRC-related mortality due to its high adherence rates. The model predicts that integrating this non-invasive test into existing screening programs could significantly reduce CRC-related deaths, especially among previously unscreened populations. Patients screened with blood-based testing are predicted to gain more life years compared to those screened with FIT or mtsDNA tests.

Guardant Health's Shield™ blood test has received FDA approval as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older at average risk. This marks a significant milestone as the first blood test approved for CRC screening that meets Medicare coverage requirements. The test offers an easy and convenient alternative to traditional screening methods, potentially improving CRC screening rates.

Key points:

• Shield demonstrated 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia in the ECLIPSE study
• Over 90% adherence rate in real-world clinical settings
• Aims to address the gap in CRC screening rates, currently at 59% in the U.S.
• Potential to detect more cancers at an early stage when they are more treatable

Guardant Health (Nasdaq: GH), a leading precision oncology company, announced it will release its second quarter 2024 financial results on Wednesday, August 7, 2024, after market close.

The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET, accessible via a live webcast on the company’s website.

The webcast will be archived and available for replay after the event.

Guardant Health (NASDAQ:GH) has unveiled a major upgrade to its Guardant360 liquid biopsy test, running on the Guardant Infinity smart liquid biopsy platform. The enhanced test now covers 739 genes, a tenfold increase from its predecessor, and includes all guideline-recommended genomic biomarkers for advanced solid tumors. It offers 10 times higher sensitivity in quantifying tumor burden and can identify emerging biomarkers for precise cancer characterization.

Key features of the upgrade include:

• Broader gene panel coverage
• Analysis of both actionable and emerging biomarkers
• Results delivered in 7-10 days
• Medicare and major private payer coverage
• Improved precision in treatment strategy identification

The test's expansion aims to provide oncologists with a more comprehensive view of cancer, potentially improving patient outcomes through more targeted treatment options.