Latest Presention on MX-ICP

View the latest presentation on Multiplexed ICE COLD-PCR (MX-ICP) for Detection of Low-Level Mutations in Any Liquid Biopsy Sample using Sanger Sequencing, NGS, or ddPCR by Katherine Richardson, Ph.D. V.P., Research & Development
  • product-image-category-oncology

MX-ICP EGFR exon 20 (T790M) Analysis

MX-ICP amplification and sequencing of EGFR exon 20 (T790M) to detect if resistance has developed to EGFR-TKI therapy.

Product Description

MX-ICP amplification and sequencing of EGFR exon 20 (T790M) to detect if resistance has developed to EGFR-TKI therapy.

200000

81235

Multiplexed ICE COLD-PCR amplification of the EGFR T790M region

Using patient DNA extracted from blood, EGFR codon 790 is evaluated by Multiplexed ICE COLD-PCR (MX-ICP) and bi-directional sequence analysis. This testing methodology will not detect mutations outside of this codon. A negative (wild type) result does not rule out the presence of a mutation that may be present but below the limits of detection for this assay (approximately 0.05%). The predictive value of this test applies to EGFR-tyrosine kinase inhibitor (TKI) therapies, not to other therapeutic agents. Rare polymorphisms exist that could lead to false-negative or false-positive results. Interpretation of test results should be in the context of the patient’s clinical and family histories, and other laboratory test results. Testing is performed at the Transgenomic CLIA Laboratory at 12325 Emmet St, Omaha, NE.

7 – 10 business days

10 ml of blood shipped at room temperature

1. Prabhakar, Charles. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res 2015; 4(2):110-118.
2. NCCN NSCLC Clinical Guidelines. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
3. Niederst, M., et al. C797S promotes resistance to third generation EGFR inhibitors. Clinc Cancer Res. May 11, 2015; DOI: 10. 1158/1078-0432.
4. Price, T.J., et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14

Click here to order a complimentary MX-ICP Specimen Collection Kit(s).

Statement on Billing Policies

Transgenomic believes health care costs are shared obligations between a patient and the service provider.

Patients actively participate in their own health care by selecting health plans, physicians, pharmacies, etc. As part of that participation, patients agree to pay a percentage of the services and products they use. These payments are contractually obligated and take the form of co-payments and deductibles.

Transgenomic believes no individual or entity should interfere with established contracts between a patient and a third party insurance payer.

An individual chooses the health care coverage and services they need by purchasing health care coverage from a third party insurance provider. When a third party insurance plan defers an individual’s health care costs in exchange for payment (a monthly premium) a contract has been created.

Many states have specific laws barring the interference by outside parties in a contract. For example:

Section 18-13-119 of the Colorado Criminal Code indicates that waiving or reducing of co-payment or deductibles (interference with contractual obligations entered into between the insured and the insurer) is a class 1 petty offense.

Florida Statute § 483.035 and Florida Administrative Code 59A-7.037 indicates no owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient.

Massachusetts G.L.c. 111D, § 8(4) indicates a clinical laboratory shall not: (4) offer or give a commission, rebate, or other fee, directly or indirectly to any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory.

In Texas, the State Attorney General has indicated “the payment of benefits under an assignment does not relieve the covered person of contractual responsibility for the payment of deductibles and co-payments. A physician or other health care provider may not waive co-payments or deductibles by acceptance of an assignment.”

Additionally, third party insurance plans have specific language regarding the obligations of the insured:

From Cigna’s Patient’s Bill of Rights: (You have the responsibility to) “Pay all co-pays, deductibles and coinsurance for which you are responsible at the time service is rendered or when they are due.” http://www.cigna.com/member-rights

Transgenomic believes participating with both government and private payers will result in the lowest overall costs to the health care system.

Contracting and accepting both private and Government patients ensures the largest possible number of patients receive needed health care services.

Transgenomic believes no action it takes should jeopardize the patient-physician-provider relationship.

The Affordable Care Act of 2010 states, “A group health plan, or a health insurance issuer offering group or individual health insurance coverage, must not rescind coverage except in the case of fraud or an intentional misrepresentation of a material fact.”

http://healthreform.gov/newsroom/new_patients_bill_of_rights.html

The Insurance Lobby states, “In most states, it is illegal to routinely waive co-pays and deductibles for patients. Health care providers who do this may be charged with the crime of health insurance fraud because they are claiming the wrong amount for services when they make insurance claims. Example: If a patient has a 10 percent co-pay, the insurance company pays $90 on a $100 bill. But if the health care provider waives the co-pay, the patient’s bill is only $90 total, not $100.”

http://www.abramslaw.com/CM/Articles/Automatic-Waiver-of-Copays.asp

Transgenomic believes in providing comprehensive patient services.

No testing begins without the patient’s permission. Transgenomic is an in-network provider with many major insurance carriers to keep the patient’s out-of-pocket expenses as low as possible.

Benefits Investigation – Once we receive a test order, a Patient Services Associate contacts the patient’s insurance carrier to determine insurance benefits. We then contact the patient to explain their benefits and provide an estimate of out-of-pocket expenses.

Insurance Pre-authorization – We work with the patient, their insurance company, and physician to have testing pre-approved. This keeps the patient’s out-of-pocket expenses as low as possible.

Appeals – If the patient’s insurance company rejects the claim, we work with the physician and patient to appeal the decision.

Flexible Payment Plans – Patients may choose one of our flexible payment plans to help manage their out-of-pocket expenses. These are offered with no interest or financing fees. We do not require credit cards up front.

Patients receive consistent discounts across our entire catalogue of tests and not just for certain specialty tests.

Transgenomic believes in business practices that put patients first.

Transgenomic, Inc. ©2012 Transgenomic, Inc. All rights reserved.  Document No. 602216-00 02/12

Commercial PlanMedicare Plans
AetnaAetna
Anthem Blue Cross (BC) CTAnthem BC CT
Blue Cross Blue Shield (BCBS) ALBCBSAL
BCBSHIBCBSHI
BCBSILBCBSMI
BCBSMIBCBSMT
BCBSMTBCBSNC
BCBSNCBCBSTN
BCBSNECoventry
BCBSTNHumana
CoventryMedica Health Plans
Harvard PilgrimSelect Health
HealthChoice - OKTriCare (South and North)
HumanaUnited Healthcare
Medica Health PlansWellmark IA
Select HealthWellmark SD
TriCare (South and North)
United Healthcare
Wellmark IA
Wellmark SD
Medicaid PlansThird Party Administrator (TPA)
AetnaAmerican Choice Provider Network
BCBSHIHealthRisk Resource Group (HRGi)
BCBSILMultiPlan (Beech Street)
BCBSMIPremiere Healthcare Exchange (PHX)
BCBSMTThree Rivers Provider Network
BCBSNC
BCBSTN
Coventry
Humana
Medica Health Plans
Wellmark IA
Wellmark SD