In an interview with PharmaShots, Dr. Minnie Sarwal, CEO and Co-Founder of NephroSant shares her view on the QSant and how this urine test can improve outcomes for transplant patients. She also shed light on the need for precision therapies in kidney transplant care.

Shots:

• NephroSant's Qsant is a needle-free urine test that helps in determining if a patient's body is rejecting a transplanted kidney. Qsant uses a proprietary-based algorithm to generate a quantitative rejection risk unique for each patient, referred to as the patient's personalized "Q-Score."
• With this score, providers can catch signs of rejection early, intervene sooner to modify immunosuppressant dosages to prevent further injury or harmful side effects of large doses of medication
• NephroSant raised a Series A funding round of $16M, led by DaVita Venture Group, with participation from DigitalDx Ventures and other previous investors

Tuba:  What is the need for precision medicine in Kidney Health?

Dr. Minnie Sarwal: Chronic Kidney Disease (CKD) is a global public health crisis. One in three American adults (80 million) are at risk for CKD, and 120,000 people annually develop End-Stage Renal Disease (ESRD) leading to lifelong dialysis or kidney transplantation. The early stages of the disease are completely asymptomatic. Once the disease has progressed to the later stages, it is typically not reversible. Cleary better tools are needed to identify the earliest signs of CKD so that interventions can have a greater impact.

Tuba:  What is QSant ? Discuss its key features?

Dr. Minnie Sarwal: QSant is the first and only urine-based test for the detection of kidney transplant rejection. Most of the currently available tests are done through a blood draw. Studying urine, as opposed to other types of samples, is ideal since it comes directly from the kidney and allows a unique view into the health and potential damage of the organ. This approach can provide a better understanding of what is happening within the kidney during different stages of the disease. Therefore, we can tailor our approach to limiting and ideally reversing kidney disease in all forms. QSant also provides patients the option of sample collection within the safety and convenience of their own home, which is especially important during COVID-19.
After sample analysis is completed by NephroSant's CLIA lab, our proprietary algorithm generates a QScore, which not only determines the risk of organ rejection but also provides a quantitative measure of that risk, which correlates with rejection injury parameters in the biopsy. As a result, it provides more powerful data than a simple yes/no result.  

Source: NephroSant

Tuba:  How this novel urine test can improve outcomes for transplant patients?

Dr. Minnie Sarwal: Currently, up to 40% of all kidney transplant recipients result in clinical or sub-clinical rejection. Identifying and predicting rejection earlier will enable clinicians to intervene sooner and help patients live a longer life. Also, due to the convenience of collecting urine, it can be used serially as patients risk changes over time.

Tuba:  Discuss the importance of Series A funding received by NephroSant? Who are the key investors?

Dr. Minnie Sarwal: DaVita Venture Group led NephroSant's oversubscribed series A funding round, with participation from DigitalDx Ventures and other previous investors. The funding will be used to support research and development and the marketing of QSant. DaVita is a recognized leader in kidney care, and their expertise and experience provide the perfect complement to the vision and focus of NephroSant to redefine kidney health.

Tuba:  What is the vision of NephroSant on kidney disease across the globe?

Dr. Minnie Sarwal: Chronic Kidney Disease is a global epidemic affecting 1 in 10 adults. The countries with the highest prevalence include Russia, Mexico, Japan, Brazil, China, Australia, and Canada. In order to maximize accessibility and penetration worldwide, NephroSant is working on a point of care device that would allow testing to be done remotely, thereby getting around the increased cost and turn-around time associated with shipping samples back to a central lab.

Tuba:  QSant sets a new standard for non-invasive transplant rejection tests. Justify the statement.

Dr. Minnie Sarwal: Many blood tests have been referred to as non-invasive approaches in the past. While a blood draw is less invasive than a biopsy, it still requires a needle administered by a phlebotomist. A urine sample is a true non-invasive approach, and by giving the patient the option of an in-home sample collection method, QSant enhances patient convenience and safety, especially important in the current COVID-19 pandemic.

Tuba:  Give the clinical evidence supporting the use of QSant in detecting kidney transplant rejection.

Dr. Minnie Sarwal: In the landmark clinical validation paper published in Science and Translational Medicine, QSant was able to demonstrate sensitivity and specificity of over 95% in over 600 samples with paired biopsies. This speaks to the unique ability of QSant to both rules in and rules out the risk of rejection in kidney transplant patients. In addition, this study showed that QSant can identify all types of rejections in both adults and children.

Tuba:  What next, we expect from the company in improving Kidney Health?

Dr. Minnie Sarwal: There have already been additional publications, in peer-reviewed journals, on the use of the multi-biomarker platform in early identification of CKD, recurrence of kidney stones, IgA nephropathy, and lung transplant.

Tuba:  Share something specific with our readers about the company's growth, plans, etc. Any plans to enter other nephro indications?

Dr. Minnie Sarwal: The latest publications show the commitment of NephroSant to be more than a one-test company. The goal is to redefine kidney health through non-invasive testing aimed at the earliest signs of disease.

Image Source: IHT.Health

About Dr. Minnie Sarwal:

Dr. Minnie Sarwal is the CEO and Co-Founder of NephroSant. She has an MD (India), Ph.D. (Molecular Genetics, Cambridge University/Christ's College, UK), Diploma in child health (UK), MRCP, and FRCP (UK).

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