About our project
THE PROBLEM THAT WE SOLVE
Yesterday about 5,000 women got up and prepared to visit their oncologist for the 3-week “cycle” of chemotherapy for HER2 positive breast cancer, an aggressive form of the disease. Over the course of 3 weeks about 100,000 women go through this ritual, many with little understanding of their condition— are the drugs working? Am I getting better? Martell Diagnostic Laboratories is a Minnesota CLIA reference lab offering the blood test HERTEST, a quantitative serum HER2 ELISA. Falling HERTEST levels indicate that HER2 chemotherapy is working—rising levels may indicate a need to change drugs.
With improvements in treatment, HER2 breast cancer has become a chronic disease, and chronic diseases do best if we monitor the disease regularly with a simple blood test. But serum HER2 monitoring is not used routinely; certainly one reason, it can take more than a week to get a HERTEST result, delaying treatment decisions and compounding patient anxiety. We are about to change that—we will build a HERTEST chip that will measure serum HER2 in one hour. This will use a drop of finger-stick blood in the oncologist’s office before chemotherapy begins, quickly addressing dosage, drug selection and uncertainty.
HOW IT WORKS
It is possible to place the HERTEST ingredients (reagents) we use in the Minnesota lab on a glass or metal plate smaller than a postage stamp. Martell would supply the doctor with cartridges pre-loaded with reagents. After the cartridge is loaded with a drop of blood it would slip into a hand-held portable detection device. After an hour, the chemical reaction would be complete and the test result would be transferred by WiFi to the doctor’s electronic record system.
This process is called lab-on-a-chip and the reader is called a point of care device. This is the future of medical care, and, with your help, we intend to offer point of care serum HER2 testing to patients and their physicians. Our campaign to finance a prototype HERTEST chip should resonate with breast cancer patients, family and friends.
CLINICAL PROOF
Lab-on-a-chip uses several modern detection technologies that reside in the public domain, and we have access to one patented detection technology. That means we can use new technology to build a HERTEST chip without violating any existing patents. The major components go by the names of microfluidics, gold plasmonics, FACTT (our patented system) detection and multiplexing. Each has been used to develop chips for several applications, but not HER2. Martell will work with a biomedical engineering group at an Ivy League university to build our prototype. We estimate it will take nine months to build a working prototype.
FDA STATUS
The blood serum test we use in the Minnesota lab has been cleared by the FDA under the 510(k) procedure. Once we validate a point of care device, we will submit performance data to obtain a new 510(k). This procedure customarily takes six months.
Please note, all offers on MedStartr for this test are for Informational Use Only and are non diagnostic until cleared by the FDA. This is what the FDA calls “pre-marketing” and does not constitute an offer of a medical test that is currently FDA approved.
HOW WE HELP PATIENTS
HER2 breast cancer is treated with specific biological drugs that most often are used in combination with conventional chemotherapy. The biological drug may be extremely effective—often great, occasionally spectacular! However, drug efficacy may stop at any time without warning. This can usually be detected by using HERTEST. Fortunately, there are now a handful of biological drug options and an alternative drug may work after one drug fails. We see a patient advantage to closely monitoring drug efficacy and making adjustments as quickly as possible.
HOW WE HELP DOCTORS
Most often, medical oncologists administer chemotherapy in an office setting, where women recline in a lounge chair while receiving an intravenous infusion. This room is called the Infusion Parlor, and commonly treatment begins following some routine blood testing. With lab-on-a-chip HERTEST, the doctor will have the test result before the infusion is to begin. This allows the doctor to confirm drug efficacy or adjust the drug regimen on the spot. An opportunity to optimize drugs and dosage will be welcomed by the oncologist.
HOW WILL WE SPEND YOUR CONTRIBUTION
This campaign will fund the fabrication of a prototype chip. It is a critical proof of principle that will justify and set the stage for the completion of a point of care device.
Your contribution will go to making life better for women suffering from HER2 breast cancer!
WHO WE ARE
Martell is a venture-stage Minnesota company. Our business model is a CLIA reference lab where we test blood coming from hospitals and clinics around the country. Our first test HERTEST measures serum HER2, but we plan to introduce additional tumor biomarker tests in the future. We already know that these little chips can simultaneously perform multiple tests, and we see providing rapid testing in the doctor’s office as a major component of our future business.
Our CEO is a pioneer in the biotechnology business world, and he has recruited help from many scientists, commercial leaders and financial advisors.
HOW TO FIND US
We maintain two websites, one corporate site: www.martelldiagnostic.com and one patient site: www.hertestonline.com. You can gain much more information, including references in the medical literature. And you can easily contact us if you have questions.
-
Have a question?
If the info above does not help, you can ask the project creator directly.
-
-
){kind=link}
){kind=link}