April, 10, 2024. Laboratorios Columbia S.A. de C.V, and Milagen are pleased to announce that RBP and the investigation committee have approved the clinical protocol for the clinical study.  Monitoring the therapy efficacy in women going through NeoAdjuvant therapy.

September 28, 2023. Milagen and Laboratorios Columbia S.A. de C.V, agreed to conduct a major clinical study involving major Hospitals in Mexico City such as Instituto Mexicano de Seguro Social (IMSS), Instituto Nacional de Cancerologia (INCAN), Hospitals ABC and hospitals la Candesa, to monitor cancer therapy efficacy in women with breast cancer.

March 23, 2023. Milagen and Laboratorios Columbia S.A. de C.V, a pharmaceutical company in Mexico with 60 years of manufacturing and selling pharmaceutical products, entered in negotiation for the commercialization of Milagen cancer care products in Mexico.

Milagen is a private diagnostic company with a product portfolio for cancer care (early detection of cancer recurrence and for the monitoring of therapy efficacy in real time) and the early detection of cancer for a wide population screening of asymptomatic individuals over 45 years. 

September 02, 2022. The California Department of Public Health (CDPH) field team conducts a thorough inspection of Milagen’s clinical laboratory. The inspection team found the laboratory to be in full compliance with applicable laws and regulations and recommended issuance of a California Clinical Laboratory license.

October 2021. Milagen begins setup of its clinical laboratory to offer breast and colorectal cancer monitoring services under CLIA guidelines.

2019. Milagen broke ground on construction of its clinical laboratory with the intent to apply for CLIA laboratory certification and offer MammoCheck and IgoCheck to patients and oncologists.

January 2018. Milagen completed the analysis of two retrospective clinical studies aiming at showing efficacy of its Mammocheck test to monitor therapy response and cancer recurrence in breast cancer patients. 

The studies used serially collected serum from 26 breast cancer patients undergoing neoadjuvant therapy before follow-up care and 75 breast cancer survivors. 

Patients had been monitored for their clinical status in a longitudinal manner for several years while following regular clinical examination and imaging as necessary according to published guidelines.

April 1, 2024. Laboratorios Columbia S.A. de C.V, and Milagen are very pleased to announce that they have submitted to COFEPRIS (the Mexican regulatory Agency equivalent to FDA in USA) our application for Class II Medical device approval for the following intended uses: 1) Monitoring the efficacy of cancer therapy, in breast cancer patients, in real time; 2) Active surveillance of cancer recurrence, in cancer survivors; and 3) screening for the early detection of breast cancer in asymptomatic individuals over 45 years old.

July 15, 2023. Milagen Completed the submission of the protocol for the Mexican clinical study, and submitted it to the Mexican key opinion leaders for their evaluation and approval.

August 8, 2022-Feb. 2023. Milagen applied to the FDA for Breakthrough Device Designation of its serum-based immunoassay for the early detection of multiple cancers (breast cancer, colorectal cancer, lung cancer, prostate cancer, and ovarian cancer) in asymptomatic individuals over 45 years old.

After several rounds of discussion with the Agency, Milagen received favorable feedback and indications to include additional samples, specifically benign samples from the lung cancer patient population, DCIS samples from the breast cancer patient population and benign Type 1 samples from the colorectal cancer patient population. 

Nov. 29, 2021-August 16, 2022.  Milagen submitted its Pre-PMA submission data to the FDA for wide-population screening of asymptomatic individuals over 45 years old for the early detection of multiple cancers (breast, colorectal, lung, ovary and prostate cancer), using serum samples. 

A FDA diagnostic panel of 13 experts analyzed Milagen’s submitted data and over the course of several months contributed to several discussions about each screening test and its correlation to the tissue of origin. The FDA recognized the potential paradigm shift of serum-based assays for the early detection of cancer and made favorable recommendations going forward. Milagen and the agency agreed on the inclusion and exclusion criteria for each screening test for asymptomatic healthy individuals. 

2020. Milagen completed the construction of its clinical laboratory and continued preparations for CLIA certification.

August 2018. Milagen finalized the diagnostic validation of its assays for the monitoring of Breast and Colon cancer patients (MammoCheck and IgoCheck) to be offered as laboratory developed tests (LDTs) to patients and oncologists.

November 28, 2023. Milagen submitted its clinical data to Laboratorios Columbia S.A. de C.V,, regulatory department to prepare the dossier for COFEPRIS clearance.

June 24, 2023. Laboratorios Columbia S.A. de C.V, and Milagen, agreed to apply to COFEPRIS (the Mexican regulatory Agency equivalent to FDA in USA) to obtain the clearance for three intended uses for breast cancer early detection and for cancer management. The two companies also agreed to conduct additional clinical studies and to involve Mexican key opinion leaders using Mexican patients.

September 27, 2022. Milagen receives a California Clinical Laboratory license from CDPH and a CLIA certificate from the Centers for Medicare & Medicaid Services (CMS) allowing it to offer CLIA services to breast and colorectal cancer survivors to monitor for recurrence and cancer therapy efficacy.

May 20, 2022. Milagen announces it has filed an application with the California department of Public Health (CDPH) seeking approval to open its CLIA facility. The CLIA clinical laboratory will provide services for breast and colorectal cancer survivors in the areas of monitoring treatment efficacy and active surveillance for recurrence.

September 11, 2019. Milagen submitted a Pre-510K submission to the FDA for its test to monitor therapy efficacy and for active surveillance of colorectal patients. The agency made favorable recommendations and emphasized the need for a diverse patient sample pool in order to accurately reflect the United States’ diverse ethnic population.

June 2018. Milagen completed the analysis of a retrospective clinical study aiming at showing the efficacy of its Igocheck test to monitor therapy response and cancer recurrence in 91 colorectal cancer patients undergoing various therapy regimens. 

Patients had been monitored for their clinical status in a longitudinal manner for several years while following regular clinical examination and imaging as necessary according to published guidelines.