Oncodetect, Inc. 

In quest for superior diagnosis and treatment

 

Innovative diagnosis and therapeutic strategies

 
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1. COMPANY GOAL

OncoDetect is an early-stage biopharmaceutical company focused on the development of a diagnostic assay for cancer. Preliminary research has shown the potential to use a combination of markers as a breast cancer diagnostic tool. The company is seeking to develop a molecular diagnostic assay. This assay will identify the presence or likelihood of breast cancer through measurement of markers in blood that are also expressed in malignant tumors to identify individuals at high risk to develop breast cancer.

OncoDetect is built on the research of Dr. Ashwani Khanna performed at University of Maryland, Baltimore.

The company is applying for technology transfer grants (SBIR and STTR) to complete initial feasibility studies using human tissue and blood. The goal of these studies is to identify a minimum set of markers that can be used for diagnosis with the sensitivity and specificity of the technique compared to existing tests. At the completion of this feasibility testing, the company will seek venture funding to complete the development of a diagnostics kit and expand clinical testing.

 

2. PRODUCTS AND SERVICE

OncoDetect will develop molecular technique based diagnostic assay kits to accurately diagnose the presence and/or likelihood of breast cancer by determining the unique pattern of expression using a variety of gene markers.

Early detection can reduce the morbidity and mortality due to breast cancer. Compared to mammography and physical examination, sensitive molecular techniques will be more useful in detecting early stage breast cancer. Breast cancer cells are released into the circulation at an early stage of the disease. Our sensitive assay will detect cancer cells in peripheral blood using specific genes to provide a screening test that can be used independently to more accurately detect early stage breast cancer. One key feature that distinguishes this technique from mammography, which relies on differences in the anatomic appearance of tumors vs. normal tissue, is that it will differentiate the functional behavior of tumors vs. normal breast tissue. Therefore, this technique will be well suited to find cancers in women whose mammograms may not be very accurate. This assay will increased the specificity of cancer diagnosis by allowing clinicians to differentiate among tumors at the molecular level, leading to highly effective treatments tailored to the features of each case, and also, monitor management of each cancer patient. The ultimate goal is to detect and diagnose breast cancer to the earliest stages when its prevention will be most successful.

3. CUSTOMER DEFINITION

 The customers for the assay will be molecular diagnostic laboratories of the hospitals treating breast cancer patients, and other centers treating breast cancer patients such as "Oncology Alliance". In house testing will also be carried out for different hospitals.

4. MARKET ASSESSMENT

With over 180,000 new cases of breast cancer being diagnosed in the U.S. each year, the potential market is enormous for an effective breast cancer diagnosis assay. Breast cancer diagnostics and therapeutics represent a $10 billion industry worldwide. In the United States alone, there are over 80,000,000 women per year who potentially could benefit from such an assay done as part of their routine health care. The world market for diagnostics in 2003 was estimated at $28 billion, will reach $39 billion by 2008.

X-ray mammography is by far the most prevalent diagnostic technique. Ultrasound and MRI are used when x-ray mammography is likely to be inconclusive because of highly dense breasts. Sensitivity of mammography is high, ~90%, but specificity is poor, ~40% (leading to biopsies in ~50% of overall cases that turn out to be benign).

Biopsy is required when a breast image reveals a suspicious lesion. Between 800,000 and 1.25 million biopsies are performed each year with a cost of $800 to $3,000, depending on the type of biopsy performed. (USFDA Center for Devices – Radiological Heath & Office of Women’s Health). According to the American Cancer Society, approximately 80% of breast biopsies are benign. Since biopsies are generally performed when a breast image reveals a suspicious lesion, sensitivity is not applicable, but specificity of biopsies is excellent.

Many molecular and genetic tests are under development, but only one test is widely accepted: if a woman carries a hereditary mutation in genes BRCA1 or BRCA2, she has a 36%-85% chance of developing cancer before age 70 (National Cancer Institute). However, this test is of limited value since a relatively small percentage of breast cancers are hereditary in nature.

OncoDetect assess its new multiplex PCR assay based on specificity and sensitivity as compared to conventional tests (mammography and biopsy) and evaluate it as appropriate for different types of cancer (DCIS, fibrosis and benign). If a new test can show greater sensitivity than mammography, it could replace mammography. If sensitivity is not high, but specificity is good, it could be used in conjunction with mammography to eliminate unnecessary biopsies.

5. SALES AND MARKETING STRATEGY

Initially, OncoDetect’s diagnostic assay may be sold as a research product to diagnostic testing laboratories, without the benefit of FDA certification. Eventually, the company will seek to perform expanded clinical trials and obtain the appropriate FDA certification (510k or PMA) to market the product based its comparison with existing diagnostic techniques. OncoDetect will ultimately market the product directly or license the product to pharmaceutical and diagnostic companies.

6. MANAGEMENT

Dr. Ashwani Khanna, PhD is founder of OncoDetect and serves as the company’s Chief Science Officer. He is also Associate Professor of Medicine at the University of Maryland, Baltimore. OncoDetect was co-founded with TechStar, a Milwaukee-based organization that assists in corporate formation. TechStar will serves as interim management for OncoDetect until the company completes the technology validation phase and raises sufficient funds to hire a management team.

7. FINANCIAL HIGHLIGHTS

 The company may also seek from $200,000 to $500,000 in venture funding at the completion of the validation phase. By leveraging Federal technology transfer grants to complete the initial technology validations, the company will mitigate technical risk and lead to a risk/return profile acceptable to venture investors.

 8. USE OF FUNDS

OncoDetect has an early stage technology with significant potential for a superior product in a large and proven market. Given the stage of technology validation, the company is seeking to leverage Federal grants designed to encourage technology transfer to advance the technology. When the company successfully completes the technology validation phase, the company will be positioned for venture funding.

Depending on results on initial testing, OncoDetect believes that it can complete the technology validation phase for between $150,000 and $300,000. The company is pursuing Federal STTR and SBIR phase 1 grants which could supply up to $100,000 for an initial six-month study. Following a successful phase 1 study, the company could received up to $750,000 for a phase 2 study which would allow it to complete the technology validation phase, complete the development of the diagnostic kit and obtain additional clinical results using the diagnostic kit.

Initial funds, either from federal technology transfer grants or other sources will be used to perform clinical testing to validate the technology. The company has identified specific development objectives and has targeted grant applications toward achieving these objectives – including testing increased number of samples from human tissue and blood, correlating results with an independent diagnoses made using existing techniques, identifying an optimal set of markers, and determining the sensitivity and specificity of the diagnostic assay. Funds will be used to purchase laboratory equipment, hire research scientists, and to develop and validate the diagnostic assay.