Zydus Lifesciences Limited has signed an exclusive agreement with Myriad Genetics, a leader in molecular diagnostic testing and precision medicine, to launch cancer-risk assessment diagnostic tests in India. The partnership was announced through a press release dated December 19, 2025.

Agreement Details

Under the exclusive agreement, Zydus will introduce three key diagnostic tests to the Indian market:

These globally trusted tests have been widely adopted in North America, Europe, and major global cancer centres, and will now empower Indian oncologists with cutting-edge genomic decision-support tools.

Test Specifications and Applications

The MyRisk Test analyzes 63 clinically significant genes including BRCA1, BRCA2, PALB2, ATM, TP53, MLH1, and MSH2, covering cancer types like breast, ovarian, lung, pancreatic, colorectal, endometrial, prostate, gastric, and melanoma. The test includes a Risk Score that combines genetic and clinical data to predict 5-year and lifetime breast cancer risk.

The MyChoice HRD Plus Test determines HRD status based on genomic alterations in BRCA1 and BRCA2 genes and Genomic Instability Score using Myriad's proprietary algorithm. This enables healthcare professionals to identify patients with advanced ovarian cancer who are more likely to respond to targeted therapies.

The Prolaris Test is an RNA-based gene expression test that quantifies tumour aggressiveness and provides patient-specific risk scores, helping clinicians determine treatment approaches and 10-year risk of metastasis.

Management Commentary

Dr. Sharvil P. Patel, Managing Director of Zydus, stated that the agreement marks a major step in expanding access to precision diagnostic tests for cancer treatment in India. He emphasized that the tests will help doctors develop personalized treatment plans, predict disease progression, and streamline clinical workflows.

"This collaboration with Myriad Genetics will strengthen clinician education and diagnostic infrastructure so that patients benefit from earlier, more accurate risk assessment and more confident treatment planning," Dr. Patel added.

Brian Donnelly, Chief Commercial Officer for Myriad Genetics, described the collaboration as an important step forward in expanding precision oncology across India, noting that Myriad tests aim to empower clinicians with actionable information for personalized care.

Market Impact

The partnership addresses the increasing incidence of cancers globally and in India specifically. With rising prostate cancer incidence in India, the Prolaris Test offers a clinically validated tool for personalized therapy decisions. The collaboration is expected to make personalized, evidence-based cancer care accessible to patients across India's healthcare system.

Zydus Lifesciences announced that Sentyln Therapeutics has received FDA acceptance for the resubmission of its New Drug Application (NDA) for CUTX-101, intended to treat Menkes disease in pediatric patients. The FDA has assigned January 14, 2026 as the new PDUFA Target Action Date for the resubmission.

Regulatory Timeline and Acceptance Details

The FDA accepted the resubmission as a Class I response, marking a significant milestone in the approval process for CUTX-101. Sentyln resubmitted its revised NDA on November 14, 2025 after receiving a complete response letter (CRL) from the FDA on September 30, 2025.

Complete Response Letter Analysis

The CRL cited observations regarding the manufacturing sites cGMP compliance but did not identify any other approvability concerns. Importantly, the FDA found no deficiencies in CUTX-101's efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy.

CUTX-101 Clinical Efficacy Data

CUTX-101 is an investigational copper histidinate candidate that showed statistically significant improvement in overall survival for Menkes disease subjects. The clinical trial results demonstrated an early 80.00% reduction in the risk of death compared to untreated historical controls.

Market Significance and Disease Impact

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease, a rare X-linked recessive pediatric genetic disease. The condition impacts an estimated 1 in 34,810 to as high as 1 in 8,664 live male births and is characterized by distinctive clinical features including sparse and depigmented hair, connective tissue problems, and severe neurological symptoms.

This FDA acceptance brings the potential first treatment for Menkes disease closer to approval, offering hope for patients and families affected by this rare condition.