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Real-time therapy monitoring for patients with stage IV solid tumors

Our Mission

Our mission and passion is to improve the lives of cancer patients. We develop novel, blood-based assays for patients with cancer. We are currently developing a new product named Alibrex®. Alibrex is a blood test designed to identify, in real-time, stage IV cancer patients who are experiencing disease progression. Alibrex is will be available in late 2024, early 2025.

Alibrex: Real-time Therapy Monitoring

Under the current standard of care, it takes three months before an oncologist knows if a patient's treatment is working. Alibrex is a real-time therapy monitoring system that allows oncologists to assess whether a patient's treatment is working in just 12 days after starting treatment - regardless of tumor or therapy type. The benefits of Alibrex are:

  • Reduced toxicity from ineffective therapy.
  • Patients can be moved quickly to another cancer treatment while they are still healthy enough to tolerate and potentially benefit from a change in therapy.
  • Reduced anxiety from waiting months to find out if a treatment is working.
  • Reduced out-of-pocket expenses of ineffective therapies.
  • Improvement in the shared treatment decision making process via a personalized approach based on the patient's individual tumor biology.
  • Efficient use of resources expended on drug therapy, hospitalizations, and administrative costs.

How the Alibrex System Works

The idea behind how Alibrex works is actually very simple. Tumors shed DNA into the blood. When tumors grow, the amount of DNA shed into the blood increases. The Alibrex system works by comparing the concentration of DNA in the blood prior to the start of treatments with the concentration of DNA in the blood after the administration of the 1st cycle of treatment. If the concentration of DNA in the blood increases, it is indicative of patient's tumor growing because the cancer treatment is ineffective, or the tumor is not responding to treatment.

Alibrex system work flow

Our abilitity to detect extremely small changes in the quantity of DNA in the blood enables us to assess the treatment effectiveness after only 12 days from the first dose of therapy. Because the turn-around time of running our test is usually less than a day, we can usually get an answer back to the physician before the patient has been given a second cycle of therapy, in other words, in real time!

Clinical Results

Jewish General Hospital

Montreal, Canada
Stage IV colorectal cancer patients (n = 39) vs healthy patients (n = 40)

This proof-of-concept study was conducted to determine if our technology was able to distinguish small fragments of DNA between cancer and non-cancer patients and between cancer patients who have been treated versus those who have not been treated. With an area under the curve (AUC) of 0.989, the results of this study were positive.

Results1:
0.989
AUC

MD Anderson

Dr. Scott Kopetz, MD, PhD, FACP
Stage IV Colorectal Cancer Patients (n = 32)

This concordance study compared Alibrex results at 14 to 28 days against RECIST results at 9 to 12 weeks. A positive test outcome indicates the study participant's disease progressed (PD), a negative test outcome indicates the participant's disease did not progress (non-PD). The results of this study were positive. Alibrex was able to predict 63% of participants with PD or non-response to therapy. Most critically, there were no false-positive results.

Results2:
100%
PPV
65%
NPV

CADEX-0001

Multi-site, Multi-country Study
Stage IV Colorectal, Breast & Lung Cancer Patients (n = 130)

This concordance study compared Alibrex results at 12 to 21 days against imaging results at 9 to 12 weeks. A positive test outcome indicates the study participant's disease progressed (PD) or non-response to therapy, a negative test outcome indicates the participant's disease has not progressed (non-PD), or responsive to therapy. The results of this study were positive.

Results3:
100%
PPV
91%
NPV

The CADEX-0001 results showed an area under the curve (AUC) of 0.93 when Alibrex (at 12 to 21 days) is compared against imaging (at 9 to 12 weeks).

Scatter Plot (n = 130)
ROC Curve
ROC Curve (n = 130)
ROC Curve

Brief description of CADEX-00014:

  • Multi-site study involving eleven centers located in two countries.
  • Investigated stage IV colorectal, lung and breast cancer.
  • Whole blood specimens were shipped to our lab at ambient temperature - just as they would in a commercial or normal clinical setting.
  • Study was open to all patients regardless of which therapy they were receiving. CADEX-0001 included patients receiving chemotherapy, targeted therapies, immunotherapy, and combinations thereof.
Clinical Result Notes:
2
The poster presentation included 20 patients. An additional twelve patients were added to the study in 2019. Sensitivity and specificity based on comparison to RECIST.
3
Alibrex results versus imaging. An imaging result is considered positive if and only if the total tumor burden (i.e., sum of lesion diameters) grew by ≥20%.
4
For a more complete description of CADEX-0001, please see ClinicalTrials.gov.

Our Team

Management Team

Haack - CEO
Bill Haack, MA
President & CEO, Board, Co-founder
Sinha - CSO
Sudhir Sinha, Ph.D
CSO, Board, Co-founder
Knopf - CMO
Kevin B. Knopf, MD, MPH
Chief Medical Officer
Hall - SVP Medical Affairs
Patrick Hall, D.Ph
Sr. VP, Medical Affairs, Co-founder
Friedman - VP Medical Operations
Lyssa Friedman, RN, MPA
VP, Medical Operations
tStitt - Sr. Director, Business Development
Tom Stitt
Sr. Director, Business Development

Medical & Technical Advisors

Dr. Svedman
Christer Svedman, MD, Ph.D
Dr. Gedye
Craig Gedye, BScHons MBChB FRACP Ph.D
Dr. Parikh
Aparna Parikh, MD
Dr. Strohbehn
Garth W. Strohbehn, MD
Dr. Shannon
Bill Shannon, Ph.D MBA

Lost, But Never Forgotten

Dr. Spitzer
Gary Spitzer, MD
Former Chief Medical Officer

Contact Us

How to contact us

Cadex Genomics office location
1615 Poydras Street
Suite 900
New Orleans, LA 70112

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