Novala Biotech

What Novala Biotech does

Novala Biotech Pvt. Ltd. is a Nepal-based biotechnology company founded in 2021 that develops and manufactures In-Vitro Diagnostic (IVD) rapid test kits using lateral flow immunoassay (LFIA) technology with colloidal gold reagents and monoclonal antibodies. The company produces approximately 15 diagnostic kits spanning reproductive health (Novasure pregnancy test and Ovasure ovulation test), infectious disease detection (HIV-1/2, Hepatitis B and C, Dengue NS1, Typhoid, Tuberculosis, COVID-19, Strep A, Chlamydia, Syphilis, Leptospira, H. pylori, Vibrio Cholerae O1), and gastrointestinal screening (Transferrin/FIT for colorectal cancer). The company is headquartered in Lalitpur (Kathmandu), Nepal, and operates with a multidisciplinary team of 1-10 health and research professionals.

Novala Biotech generates revenue through manufacturing and one-time sales of diagnostic kits, distributed via exclusive partnership with CRS Healthcare (announced November 2024) for nationwide reach in Nepal, complemented by retail pharmacy channels and additional distributors (Spectrum Healthcare, Pacific Commercial Company). The company holds ISO certification for manufacturing quality and sources proprietary polyclonal antibodies through its technology partnership with Shikhar Biotech, Nepal's first and only antibody company. Clinical performance data for the kits shows high sensitivity and specificity (typically 95-99% across product lines), positioning Novala as a domestic manufacturer addressing Nepal's diagnostic import dependency and rural healthcare access gaps.

The company is privately held and bootstrapped with no external institutional funding rounds disclosed. Leadership comprises Sunita Gautam as Chairperson and Prabhat Adhikari as Founder and Medical/Scientific Advisor. The business model targets healthcare professionals (gynecologists, clinics), retail pharmacies, and individual consumers across Nepal's South Asian market, with the stated mission of achieving national self-sufficiency in diagnostic manufacturing.

Name

Novala Biotech

Legal name

Novala Biotech Pvt. Ltd.

Website

https://novala.com.np

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Novala Biotech is a Nepal-based manufacturer of In-Vitro Diagnostic rapid test kits using lateral flow immunoassay technology, producing pregnancy, ovulation, and infectious disease tests distributed nationwide via CRS Healthcare exclusive partnership and pharmacy retail channels.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics (Rapid Diagnostic Test Kits)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industry

Pregnancy, Fertility & Women’s Health Rapid Tests (hCG, ovulation, vaginal infection) (HLAHAOAF)

Keywords

• In-vitro diagnostics
• Rapid test kits
• Pregnancy tests
• Infectious disease diagnostics
• Lateral flow immunoassay

Headquarters

HQ city

Kathmandu

HQ country

Nepal

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales

Revenue model

1. Diagnostic Kit Sales: Manufacturing and selling of In-Vitro Diagnostic (IVD) rapid test kits for various diseases and conditions including infectious diseases, pregnancy tests, fertility tests, and gastrointestinal screening
2. Distributorships: Revenue generated through distribution partnerships including exclusive partnership with CRS Healthcare for nationwide distribution of pregnancy and ovulation test kits

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels4 records

Core offering

Novala Biotech develops and manufactures In-Vitro Diagnostic (IVD) rapid test kits in Nepal using lateral flow immunoassay technology. Its portfolio includes over-the-counter pregnancy (Novasure) and ovulation (Ovasure) test kits, plus a broad range of clinical rapid diagnostic kits for infectious diseases such as HIV, Hepatitis B and C, Dengue, Typhoid, Tuberculosis, Leptospirosis, COVID-19, and others, as well as gastrointestinal screening tests (Transferrin/FIT).

Product overview

Novala Biotech is a biotechnology company specializing in the development and manufacturing of In Vitro Diagnostic (IVD) rapid test kits for Nepal. Their product portfolio consists of lateral flow immunoassay-based rapid diagnostic tests covering infectious diseases (HIV, Hepatitis B and C, Dengue, Typhoid, Leptospirosis, Brucellosis, H. pylori, COVID-19, Tuberculosis, RSV, Adenovirus, Rotavirus, Strep A, Chlamydia, Syphilis, Cholera), gastrointestinal screening (Transferrin/FIT for colorectal cancer screening), and fertility/reproductive health (Novasure pregnancy tests and Ovasure ovulation tests). All products are manufactured in Nepal as part of the company's mission for national self-sufficiency in diagnostics.

Differentiator

Problem solved

Functional benefit

Brands

• Novasure: One step urine HCG pregnancy test kit - single use rapid diagnostic tool for early pregnancy detection.
• Ovasure

Products and services

• Novasure Pregnancy Test Kit One-step urine HCG pregnancy test kit that uses colloidal gold reagent and monoclonal antibodies to detect human chorionic gonadotropin (hCG) in urine samples; intended for early pregnancy detection by consumers and clinicians. Single-use OTC rapid diagnostic.
• Ovasure Ovulation Test Kit One-step urine ovulation LH test kit designed to detect the Luteinizing Hormone surge and identify the most fertile days for couples trying to conceive; single-use OTC product.
• Transferrin Rapid Test Cassette (Feces) Lateral flow immunoassay for qualitative detection of transferrin in human feces, intended for early screening of gastrointestinal bleeding including colorectal cancer.
• HIV-1 and HIV-2 Rapid Test Kit Third-generation rapid, qualitative, sandwich immunoassay for simultaneous and differential detection of total antibodies to HIV-1 and HIV-2 viruses in human serum or plasma.
• Leptospira IgG/IgM Rapid Test Kit Lateral flow immunoassay for qualitative detection of IgG and IgM antibodies to Leptospira interrogans in human whole blood, serum, or plasma.
• HBsAg Rapid Test Kit Qualitative immunoassay for detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma for diagnosis of Hepatitis B virus infection.
• H. pylori Antigen Rapid Test Kit Qualitative immunoassay for detection of Helicobacter pylori antigens in human stool samples.
• Salmonella Typhi Antigen Rapid Test Kit Qualitative membrane strip immunoassay for detection of Salmonella Typhi antigen in human fecal specimens for diagnosis of typhoid fever.
• Tuberculosis Antibodies Rapid Test Cassette Lateral flow immunoassay for qualitative detection of antibodies to Mycobacterium tuberculosis in human whole blood, serum, or plasma.
• Cardiac Troponin I Rapid Test Lateral flow immunoassay for qualitative detection of cardiac Troponin I in human whole blood, serum, or plasma for diagnosis of acute myocardial infarction.
• Strep A Rapid Test Kit Rapid immunoassay for qualitative detection of Group A Streptococcal antigen from throat swab specimens.
• Dengue NS1 Antigen Rapid Test Kit Chromatographic immunoassay for qualitative detection of Dengue virus NS1 antigen in blood serum or plasma.
• Vibrio Cholerae O1 Antigen Rapid Test Kit Lateral flow chromatographic immunoassay for qualitative detection of Vibrio cholerae O1 antigens in human fecal samples.
• Chlamydia Antigen Rapid Test Cassette Rapid qualitative immunoassay for detection of Chlamydia trachomatis antigen in female cervical swab, male urethral swab, or male urine samples.
• HCV Rapid Test Kit Rapid qualitative immunoassay for detection of antibodies to Hepatitis C Virus in human serum or plasma.
• Syphilis Rapid Test Kit Qualitative immunoassay for detection of antibodies to Treponema pallidum (causative agent of syphilis) in human serum or plasma.
• COVID-19 Antigen Rapid Test Kit Lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, nasal, or oropharyngeal swabs.

Quantifiable outcome

• Over 96% accuracy for ovulation detection (Ovasure)
• +8 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered flagship, core and minor.

• CRS Healthcare P LtdflagshipChannel Partner/ Reseller/ Distributor · 11 November 2024CRS Healthcare is a wholly owned subsidiary of Nepal CRS Company established to distribute and sell health products with focus on family planning, maternal-child health, and HIV prevention. Exclusive partnership to distribute Novasure Pregnancy and Ovasure ovulation test kits nationwide, including remote areas of Nepal. Partnership announced November 11, 2024.
• Shikhar BiotechcoreTechnology or IntegrationShikhar Biotech is described as the first and only antibody company in Nepal, producing thousands of high-quality goat polyclonal antibodies. They partner with subsistence farmers in Kathmandu for operations where goats are free range and partially owned by farmers. Experts in antibody validation using ELISA, Western blots, Immunofluorescence, Flow Cytometry and Immunohistochemistry.
• Central Diagnostic LaboratorycoreStrategic or Co-development PartnerCentral Diagnostic Laboratory and Research Center (CDL) is a category 'A' diagnostic lab known for premium diagnostic services alongside an innovative approach to diagnostics and patient care.
• Pacific Commercial CompanyminorChannel Partner/ Reseller/ DistributorPacific Group is a group of trading and manufacturing companies with business history of more than three decades. Proven strength in different fields including trading of medical equipment, analytical equipment, dental equipment, health and finance.
• Spectrum HealthcareminorChannel Partner/ Reseller/ DistributorSpectrum Healthcare is a dynamic importer and distributor dedicated to bringing critical medical products such as biotechnological products like vaccines and pulmonary dosage forms along with diagnostics kits.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Wondfo Biotech: China-based global manufacturer of lateral flow rapid diagnostic tests across pregnancy, infectious disease, and drugs-of-abuse categories. Directly comparable to Novala in core LFIA technology and broad rapid-test menu serving similar customer segments.
• SD Biosensor: Korea-headquartered IVD manufacturer specializing in rapid diagnostic test kits (lateral flow) for infectious diseases including HIV, dengue, and tropical pathogens. Comparable product technology and emerging-market distribution model.
• Acon Laboratories: US/global IVD company producing lateral flow rapid tests across pregnancy, ovulation, infectious disease, and urinalysis. Closely mirrors Novala's core women's health and infectious disease portfolio.
• Premier Medical Corporation: India-based manufacturer of rapid diagnostic test kits including pregnancy, ovulation, malaria, dengue, HIV and other infectious diseases. Closest South Asian analog to Novala in scale and product mix.
• Artron Laboratories: Canada-based manufacturer of lateral flow rapid test kits (fertility, infectious disease, drugs-of-abuse). Comparable LFIA technology platform with similar women's health and infectious disease focus.

Broad incumbents

• Bio-Rad Laboratories: Global life science and clinical diagnostics company offering quality controls, immunoassays, and IVD reagents. Comparable in lateral flow / immunoassay reagent manufacturing, with broader scale and regulatory footprint.
• Tulip Diagnostics (PerkinElmer): India-based IVD manufacturer (now part of Revvity/PerkinElmer) producing rapid diagnostic kits, reagents, and instruments across a much broader portfolio. Direct overlap in pregnancy, ovulation, and infectious disease rapid tests.
• Abbott Rapid Diagnostics: Global IVD leader offering extensive rapid diagnostic portfolios (Binax, Determine, Panbio) across infectious disease and pregnancy. Competes in nearly every product category Novala offers, with vastly greater resources and regulatory depth.

Emerging players

• Trivitron Healthcare: India-headquartered medical technology company with a significant IVD and rapid test kit business spanning infectious disease, women's health, and clinical chemistry. Operates in adjacent South Asian markets with overlapping product categories.
• Meril Diagnostics: India-based IVD manufacturer producing rapid test kits, reagents, and instruments for infectious disease, cardiology, and women's health. Comparable emerging-market IVD player with overlapping product lines.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/novalabio
• Facebookfacebook.com/novala-biotech
• LinkedInlinkedin.com/company/novala-biotech

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Novala Biotech