Oncomine Breast cfTNA Assay Test
About Oncomine Breast cfTNA Assay Test
| Field | Value |
|---|---|
| Also Known As | Oncomine Breast cfDNA Assay Test, Breast Cancer Liquid Biopsy NGS Panel Test, ctDNA Breast Cancer Panel Test |
| Sample Type | Peripheral blood (10 mL in specialised cell-free DNA collection tube) |
| Fasting Required | No fasting required |
| Report Time | 20 days |
| Recommended For | Adults with breast cancer (primarily metastatic or advanced); both genders, predominantly females |
| Price | Starting at ₹36,000 |
What is an Oncomine Breast cfTNA Assay Test?
The Oncomine Breast cfTNA Assay test is a specialised blood-based genetic test that detects tumour-derived DNA circulating in the bloodstream. It is used primarily for patients with advanced or metastatic breast cancer who need tumour genetic profiling without a surgical tissue sample.
The test analyses cell-free DNA (cfDNA) extracted from blood plasma using next-generation sequencing (NGS). It is also known as the Oncomine Breast cfDNA Assay test or the Breast Cancer Liquid Biopsy NGS Panel test.
What Does an Oncomine Breast cfTNA Assay Test Measure?
This test analyses circulating tumour DNA (ctDNA) shed by breast cancer cells into the bloodstream. It identifies specific genetic mutations across 10 clinically significant genes. Below are the key components examined.
| Gene or Parameter | What It Indicates |
|---|---|
| AKT1 | Mutations linked to cancer cell survival and growth |
| EGFR | Epidermal growth factor receptor alterations |
| ERBB2 (HER2) | HER2 gene changes relevant to targeted therapy |
| ERBB3 | Receptor mutations associated with treatment resistance |
| ESR1 | Estrogen receptor mutations; common in hormone therapy resistance |
| FBXW7 | Tumour suppressor gene alterations |
| KRAS | Signalling pathway mutations affecting cancer growth |
| PIK3CA | Frequent mutation in hormone receptor-positive breast cancer |
| SF3B1 | RNA splicing gene linked to cancer progression |
| TP53 | Tumour suppressor gene; one of the most commonly mutated in cancer |
| Single nucleotide variants (SNVs) | Single-letter changes in the genetic code at mutation hotspots |
| Short insertions/deletions (indels) | Small additions or removals of genetic material |
| Variant Allele Frequency (VAF) | The percentage of mutant DNA detected relative to total cfDNA |
Version 2 of this assay also covers copy number variations (CNVs) in CCND1, ERBB2, and FGFR1, along with broad TP53 coverage.
Why is an Oncomine Breast cfTNA Assay Test Done?
Oncologists order this test to obtain a genetic profile of breast tumours using a simple blood draw rather than a surgical biopsy. It helps guide treatment decisions and track disease changes over time.
Common Symptoms That May Require This Test
The following situations or symptoms may lead an oncologist to order this test:
- Disease progression on current therapy with a need to identify resistance mutations
- Persistent unexplained fatigue in a patient with known breast cancer
- New bone pain suggesting possible metastatic spread
- Unexplained weight loss in a patient under active cancer monitoring
- Need for non-invasive tumour profiling when tissue biopsy is not possible
- Suspected cancer recurrence after treatment
- Monitoring response to targeted or endocrine therapy
Conditions This Test Can Help Detect
This test is used across several clinical scenarios in breast cancer care:
- Mutations in ESR1 and PIK3CA that drive resistance to endocrine (hormone) therapy
- PIK3CA mutations, found in approximately 40% of hormone receptor-positive, HER2-negative advanced breast cancers
- TP53 mutations, which are among the most frequently detected variants in metastatic disease
- Minimal residual disease (MRD), meaning microscopic cancer remaining after treatment
- Eligibility for targeted therapies such as PIK3CA inhibitors and novel endocrine agents
Oncomine Breast cfTNA Assay Test for Chronic Disease Monitoring
For patients with metastatic breast cancer, this test plays an important role in long-term monitoring. Serial testing every 3 to 6 months, or at key clinical decision points, can reveal whether treatment is working or whether resistance mutations are emerging. Because liquid biopsy can be repeated over time, it helps track how the tumour evolves without repeated surgical procedures.
How to Prepare and What to Expect
No special preparation is required for the Oncomine Breast cfTNA Assay test procedure, but there are a few practical steps that will help ensure a good-quality sample.
Do You Need to Fast?
No, fasting is not required before this test. You may eat and drink normally on the day of your appointment.
Practical Tips Before Your Test
A few simple steps before your appointment can help ensure accurate results:
- Bring a detailed clinical history, including your symptoms, previous test results, and treatment records, as this is required for the test
- Inform your oncologist about all current medications, particularly chemotherapy or targeted therapies
- Stay well hydrated before blood collection
- Avoid strenuous physical activity on the day of the test, as it may affect cfDNA levels in the blood
- Wear clothing with easy access to the inner arm for a comfortable blood draw
Step-by-Step Procedure
Here is what to expect during the Oncomine Breast cfTNA Assay test procedure:
- A trained phlebotomist cleans the inner arm and draws 10 mL of blood into a specialised cell-free DNA collection tube (Streck tube)
- The sample is stored and transported to the laboratory at controlled room temperature
- In the laboratory, the blood is processed to separate the liquid plasma from blood cells
- Cell-free DNA is carefully extracted from the plasma using specialised isolation kits
- The cfDNA is prepared into amplicon libraries using multiplex PCR, then analysed using next-generation sequencing (NGS)
- Bioinformatics analysis identifies mutations and calculates the variant allele frequency (VAF) for each detected change
Factors That Can Affect Accuracy
Several factors may influence how reliably the test detects mutations:
- Amount of input cfDNA (20 ng is recommended for the best sensitivity)
- Cancer stage and disease activity, as later-stage cancers shed more ctDNA into the blood
- Recent chemotherapy, which may temporarily reduce ctDNA levels
- Sample processing time, as cfDNA degrades if the sample is not handled promptly
- Clonal hematopoiesis, a non-cancerous change in blood cells that can be mistaken for tumour mutations
- Tumour location and tissue type, which affect how much ctDNA is released
Understanding Your Oncomine Breast cfTNA Assay Test Results
Results from this test are reported as a qualitative genetic profile rather than a single number. Your oncologist will review findings in the context of your overall clinical picture.
| Parameter | Result Type | What It May Suggest |
|---|---|---|
| Mutations detected | Positive | Tumour-derived DNA identified; specific variants listed with VAF |
| No mutations detected | Negative | No pathogenic variants found in tested genes |
| Variant Allele Frequency (VAF) | Percentage value | Proportion of mutant DNA relative to total cfDNA |
A positive result identifying ESR1 or PIK3CA mutations may indicate resistance to hormone therapy or eligibility for specific targeted agents. A negative result may reflect good treatment response, early-stage disease with low ctDNA shedding, or, in some cases, a false negative due to insufficient ctDNA in circulation.
Disclaimer: These ranges are general guidelines. Your doctor will interpret your results based on your age, health history, and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Low tumour burden or early-stage disease can produce very low ctDNA levels, which may result in a negative finding even when mutations are present. Recent chemotherapy may also temporarily suppress ctDNA, affecting detection. Your oncologist will consider your tumour fraction alongside these results before drawing any conclusions.
Guidelines During Treatment Monitoring
These tips support your overall wellbeing during monitoring:
- Follow your oncologist's treatment plan and attend all scheduled appointments
- Maintain a balanced diet and appropriate physical activity as advised by your care team
- Report any new or worsening symptoms to your doctor without delay
Lupin Diagnostics Oncomine Breast cfTNA Assay Test Price
The Oncomine Breast cfTNA Assay test cost at Lupin Diagnostics starts at ₹36,000. This test requires a visit to a Lupin Diagnostics centre, where a peripheral blood sample is collected in a specialised tube and submitted for analysis.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 36000 |
| CHENNAI | 36000 |
| HYDERABAD | 36000 |
| KOLKATA | 36000 |
| NAVI MUMBAI | 36000 |
| PUNE | 36000 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps to book your Oncomine Breast cfTNA Assay test online:
- Select the test on the Lupin Diagnostics website
- Choose your city and preferred centre location
- Visit the centre at your scheduled time for sample collection
- Receive your report via email or WhatsApp within the stipulated turnaround time
Frequently Asked Questions
The Oncomine Breast cfTNA Assay test is a blood-based NGS test that detects genetic mutations in circulating tumour DNA (ctDNA) shed by breast cancer cells. It analyses ten genes commonly mutated in breast cancer and helps oncologists make informed treatment decisions without a surgical biopsy.
This test is most relevant for patients with advanced or metastatic breast cancer, particularly those who cannot undergo a tissue biopsy or who need monitoring for treatment response and resistance mutations. Your oncologist will advise whether this test is appropriate for your situation.
A tissue biopsy requires a surgical procedure to remove a tumour sample. The Oncomine Breast cfTNA Assay test procedure uses a simple blood draw, making it far less invasive. It can also be repeated at multiple time points to track how the tumour changes over the course of treatment.
Not necessarily. A negative result may reflect a good treatment response or low ctDNA levels due to early-stage disease. In some cases, it may be a false negative where mutations exist below the assay's detection limit. Your oncologist will interpret results alongside imaging and other clinical findings.
For patients with metastatic breast cancer, serial monitoring is typically carried out every 3 to 6 months or at key clinical decision points such as before and after a change in therapy. Your oncologist will determine the appropriate schedule based on your individual treatment plan.
This test is designed to detect mutations most commonly seen in hormone receptor-positive (HR+) and HER2-related breast cancers. It may be less sensitive in early-stage disease or cancers that shed low amounts of ctDNA. Metastatic breast cancer tends to yield the highest rate of ctDNA detection.
No. Due to strict pre-analytical protocols and the critical need to maintain the sample at controlled ambient room temperature immediately following the draw, blood collection for this test must be performed directly at a Lupin Diagnostics centre by trained clinical staff.
Oncomine Breast cfTNA Assay Test
