Two press releases

 Press releases "fed" to GPT 4 for analysis.

This is my "prompt" exactly as cut/pasted into GPT4.

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Medicare “MOLDX” is a program that gives coverage for new molecular cancer tests.  One important area is minimal residual disease testing, which is looking for traces of cancer DNA in the patient’s blood.   MOLDX issues this coverage one test (and one cancer) at a time.  Below, PART ONE is a press release from the company GUARDANT getting coverage for immunotherapy response.  The test is called “RESPONSE (TM)”.    PART TWO is a press release from the company NATERA getting coverage for its SIGNATERA (TM ) test in bladder cancer.

Please summarize each press release.  Please contract and compare the two press releases for key similarities and differences.  

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PART ONE GUARDANT PRESS RELEASE

Guardant Health Receives Medicare Coverage for Guardant360 Response™ to Monitor Cancer Patient Response to Immunotherapy

First blood-only liquid biopsy test for monitoring molecular response to immune checkpoint inhibitors now covered for US Medicare patients with metastatic or inoperable solid tumors

April 18, 2023 08:05 AM Eastern Daylight Time

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant360 Response test. Guardant360 Response is the first blood-only test that enables doctors to track molecular response through changes in circulating tumor DNA (ctDNA) levels, to get an early indication of metastatic or advanced cancer patient response to immune checkpoint inhibitor therapy.

“We are pleased that Medicare has taken this important step to make treatment response monitoring more widely available in order to assist oncologists in making more informed therapeutic decisions for their patients with solid tumor cancers”

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Following this decision, the Guardant360 Response test is now covered for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy. The coverage includes a Guardant360 CDx or LDT test before initiating therapy to establish a ctDNA baseline and a Guardant360 Response test 4 to 10 weeks after the therapy has been initiated to measure the change in ctDNA level.

“We are pleased that Medicare has taken this important step to make treatment response monitoring more widely available in order to assist oncologists in making more informed therapeutic decisions for their patients with solid tumor cancers,” said Helmy Eltoukhy, Guardant Health co-CEO.

This policy decision adds to the existing Medicare coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360® assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA conveyed coverage for Guardant360 TissueNext™, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment. In July 2022, coverage was granted for Guardant Reveal™, a molecular residual disease (MRD) test to identify cancer patients with residual or recurring stage II or III colorectal cancer who may benefit most from adjuvant therapy.

END PART ONE

// PART TWO

Natera Bladder Cancer Test

Medicare Extends Coverage of Natera's Signatera™ MRD Test to Muscle Invasive Bladder Cancer

(PRNewsfoto/Natera, Inc.)

NEWS PROVIDED BY

Natera, Inc. 

Jul 18, 2022, 08:33 ET

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AUSTIN, Texas, July 18, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it has received written confirmation from the CMS Molecular Diagnostics Services Program (MolDX) that the Signatera molecular residual disease (MRD) test has met coverage requirements for patients with muscle invasive bladder cancer (MIBC), effective April 19, 2022. To our knowledge, this represents the first coverage expansion to occur under the foundational local coverage determination (LCD) for MRD testing in solid tumors (LCD L38779), which was published in December 2021.

The decision by CMS in MIBC is based on evidence from multiple published validation studies. A study published in Nature, based on the phase III randomized IMvigor010 trial, showed that patients who tested MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy, while MRD-negative patients derived no benefit from additional systemic therapy. Another study published in the Journal of Clinical Oncology found that serial testing with Signatera detected metastatic recurrence with 100% sensitivity and 98% specificity. Both studies showed that on-treatment monitoring with Signatera can provide an early assessment of therapy effectiveness, whether in the neoadjuvant or adjuvant settings.

"This is great news for patients with bladder cancer, who face uncertain treatment decisions throughout the patient journey," said Solomon Moshkevich, general manager of oncology at Natera. "This is also a milestone for Natera, representing the first new disease indication to be covered under the foundational LCD. We look forward to working with Medicare and with the oncology community to continue incorporating Signatera MRD assessment into standard care for patients with solid tumors."

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Patients previously treated for MIBC have a high rate of recurrence, with 50% experiencing distant recurrence post-cystectomy.3 Of these, 90% of recurrences develop in the first 3 years.4,5

"To balance the risks versus benefits of adding systemic treatments like chemotherapy to radical cystectomy, we need measures to identify which patients indeed harbor micrometastatic disease, which would allow refined shared medical decisions," said Matthew Galsky, M.D., professor of medicine (hematology and medical oncology), director of genitourinary medical oncology, co-director of the Center of Excellence for Bladder Cancer at the Tisch Cancer Institute and associate director for translational research at the Tisch Cancer Institute.

This decision adds to the existing Medicare coverage for Signatera in colorectal cancer and for pan-cancer immunotherapy monitoring.

END PART TWO