Success Stories

Clinical History 
Female patient with a 19-year history of Breast Cancer and NSCLC Stage 1a diagnosed 5 years prior presented in January 2014 with PET confirmed left jugular lymph node enlargement and a RUL nodule. Fine needle aspiration confirmed metastatic NSCLC, but the tissue material was insufficient for biomarker testing. Patient received three cycles of Carboplatinum + Taxol® (paclitaxel) while undergoing concurrent CyberKnife therapy to the left neck and supraclavicular lymph nodes concluding in May 2014. Follow-up PET scan showed improved supraclavicular lymph node and stable RUL nodule. At that time, the treating physician tested the patient to predict the therapeutic benefit of using an EGFR TKI. Based on these test results, the patient was started on Tarceva® (erlotinib), an EGFR TKI therapy, which was subsequently discontinued as the patient did not tolerate the drug due to mucositis.

On November 17, 2014, NSCLC disease progression in the RUL was confirmed to be adenocarcinoma by CT guided needle biopsy. Biomarker testing was ordered, but the biopsy tissue material was insufficient.

 

Liquid Biopsy In Addition To Tissue 
The patient’s physician was familiar with ordering liquid biopsy testing from Biocept. Blood was drawn from the patient on November 21, 2014 and EGFR and ALK biomarker tests were ordered. Biocept’s liquid biopsy detected an ALK translocation in the blood and the results were reported to the patient’s physician on December 1, 2014.

Biocept’s Liquid Biopsy Enables Selection of Targeted Therapy – The “Gift of Time” 
Physician referred the patient for evaluation to participate in an immunotherapy clinical trial. However, it was determined that the best course of therapy was to proceed with an ALK-targeted therapy. As a result, the patient was treated with Xalkori® (crizotinib), from December 2014 – July 2016.

The identification of a clinically actionable biomarker and subsequent targeted therapy resulted in 18 months of progression-free survival (PFS) for the patient. In June 2016, the patient progressed with brain lesions, a new 3×1 cm lesion in the thyroid, mediastinal lymphadenopathy, and multiple RLL nodules. Patient was referred for stereotactic RT for the two brain lesions, (each receiving 2100 cGy dose in 1 fraction).

The patient was re-tested with Biocept’s liquid biopsy tests for EGFR, ALK and ROS1. The absence of clinically actionable biomarkers facilitated selection of immunotherapy over the alternative of a second-line ALK inhibitor. The patient was started on Opdivo® (nivolumab) in July 2016, and as of this publication has stable disease with limited toxicities.

Background
Sarah is a 52-year-old woman diagnosed with breast cancer. A core biopsy of her primary tumor showed that the tumor was HER2-negative and ER-positive. Based on her molecular profile, she was appropriately treated for ER+ breast cancer. Sarah had been disease-free for about 2 years after treatment for her initial cancer when she visited her oncologist, Dr. Thomas as a follow-up due to some shortness of breath. Through her work-up and imaging studies, it was discovered that the cancer had recurred, this time with lesions in Sarah’s lung.

“Can we do another biopsy?”
Dr. Thomas was concerned about whether they would be able to get enough tissue from a surgical biopsy of the lung lesion. There were additional concerns about the location of the lesion, and any adverse effects that may occur from the re-biopsy procedure. Sarah had already been scheduled for a biopsy when her doctor considered an alternative approach. Dr. Thomas ordered a liquid biopsy from Biocept.

Establishing biomarker status with a simple blood test
Sarah’s doctor explained that a “liquid biopsy” was really just a simple blood test and only required a sample of blood from Sarah. It would spare her from undergoing another biopsy and the potential adverse effects that may have resulted due to the location of her lesion. The blood sample was sent to Biocept’s laboratory to be tested for established, clinically actionable biomarkers, including HER2 and ER. Dr. Thomas received Sarah’s results 5 days later and her results were both HER2positive and ER-positive.

A liquid biopsy reveals tumor heterogeneity
After considering all therapy options, Dr. Thomas decided to treat Sarah based on the results of the liquid biopsy with a combination therapy including anti-HER2 therapy and chemotherapy. Sarah responded well to this regimen and is in remission.

More effective treatment thanks to a liquid biopsy
Sarah was able to receive the appropriate standard of care therapy without an invasive lung biopsy. Through Biocept’s test, Sarah doctors were able to determine the true biology of her tumor and concluded that she would benefit from the anti-HER2 therapy regimen.

Background
Michelle is a 79-year-old grandmother and is retired in Florida. She was diagnosed with breast cancer approximately 6 years ago. A core biopsy of her primary tumor showed that the tumor was HER2-positive and ER-positive. Based on her molecular profile, she was appropriately treated for her breast cancer. Michelle had been disease-free for many years until she felt some bone pain that lead her to the doctor. After a thorough work up and imaging study, it was determined that Michelle’s cancer had likely recurred and metastasized to her bones.

“Can we do another biopsy?”
For patients with lesions to the bone, a biopsy is routine and possible. However in Michelle’s case, the HER2 result that was positive on her primary tumor showed up negative on the bone lesion. There were some concerns that the laboratory process using decalcification for the biopsy sample may have made it difficult to obtain the HER2 results. Michelle’s oncologist recommended ordering a liquid biopsy from Biocept.

Establishing biomarker status with a simple blood test
Michelle was told that through a “liquid biopsy,” a simple test that only required a sample of blood from Michelle, they might be able to retest the HER2 status without obtaining another biopsy of her bone lesions. It would spare her from the pain and discomfort of undergoing another biopsy. The blood sample was sent to Biocept’s laboratory to be tested for established, clinically actionable biomarkers, including HER2 and ER. Michelle’s oncologist received her results 5 days later and her results were positive for HER2, as they were on her primary tumor.

More effective treatment thanks to a liquid biopsy
Michelle was able to receive the appropriate standard of care therapy without the physician needing to go back into her bone to obtain aa additional biopsy. Through Biocept’s test, Michelle’s doctors were able to determine the true biology of her tumor and concluded that she would benefit from the anti-HER therapy that she needed to fight her breast cancer.

Background
Lisa is a 58-year-old and recently diagnosed with early stage breast cancer. A core biopsy of her primary tumor showed that the tumor was HER2-negative. Based on the stage and the presentation of her disease, she was a good candidate for neo-adjuvant therapy.

“Could we have missed this patient’s HER2 status?”
For patients with small core biopsies, there exists the possibility that due to the heterogeneity of disease, a small biopsy can miss areas of tumor that are positive for HER2 (and other critical biomarkers). Lisa’s doctor was familiar with ordering a liquid biopsy test from Biocept.

Establishing biomarker status with a simple blood test
Lisa was told that through a “liquid biopsy,” a simple test that only required a sample of blood, they could double check to confirm that they had not missed any HER2 positive cells. Finding HER2 positivity in early stage breast cancer patients who are candidates for neo-adjuvant therapy can drastically change the treatment options. The blood sample was sent to Biocept’s laboratory to be tested for established, clinically actionable biomarkers, including HER2 and ER. Doctors received Lisa’s results 5 days later and her results were positive for HER2 tumor cells circulating in the blood.

More effective treatment thanks to a liquid biopsy
Lisa still received neo-adjuvant therapy, but now it was with an anti-HER2 agent regimen. Through Biocept’s test, Lisa’s doctors were able to determine the true biology of her tumor and concluded that she would benefit from the anti-HER2 therapy that she needed to fight her breast cancer. This change to targeted therapy generally increases her likelihood of disease free survival while reducing side effects.