DirectHit is a pharmacodiagnostic test used to determine the

tumor A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...

sensitivity or resistance to

drug A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via insufflation (medicine), inhalation, drug i ...

regimen A regimen is a plan, or course of action such as a Diet (nutrition), diet, exercise or medical treatment. A salt#Health effects, low-salt diet is a regimen. A course of penicillin is a regimen, and there are many chemotherapy regimens in the trea ...

s recommended for the treatment of

breast cancer Breast cancer is a cancer that develops from breast tissue. Signs of breast cancer may include a Breast lump, lump in the breast, a change in breast shape, dimpling of the skin, Milk-rejection sign, milk rejection, fluid coming from the nipp ...

by the

National Comprehensive Cancer Network The National Comprehensive Cancer Network (NCCN) is an alliance of 33 cancer centers in the United States, most of which are designated by the National Cancer Institute (one of the U.S. National Institutes of Health) as comprehensive cancer cent ...

. It is a noninvasive test performed on small amounts of tissue removed during the original

surgery Surgery is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery s ...

lumpectomy Lumpectomy (sometimes known as a tylectomy, partial mastectomy, breast segmental resection or breast wide local excision) is a surgical removal of a discrete portion or "lump" of breast tissue, usually in the treatment of a malignant tumor or bre ...

mastectomy Mastectomy is the medical term for the surgical removal of one or both breasts, partially or completely. A mastectomy is usually carried out to treat breast cancer. In some cases, women believed to be at high risk of breast cancer choose to have ...

, or core

biopsy A biopsy is a medical test commonly performed by a surgeon, interventional radiologist, an interventional radiologist, or an interventional cardiology, interventional cardiologist. The process involves the extraction of sampling (medicine), sample ...

. DirectHit was developed by CCC Diagnostics Inc., a

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

company established by former researchers from

Johns Hopkins University The Johns Hopkins University (often abbreviated as Johns Hopkins, Hopkins, or JHU) is a private university, private research university in Baltimore, Maryland, United States. Founded in 1876 based on the European research institution model, J ...

. DirectHit was launched on 14 January 2010. Currently, it is the only available test for predicting treatment outcomes for

anticancer An anticarcinogen (also known as a carcinopreventive agent) is a substance that counteracts the effects of a carcinogen or inhibits the development of cancer. Anticarcinogens are different from anticarcinoma agents (also known as anticancer or ant ...

chemotherapy Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (list of chemotherapeutic agents, chemotherapeutic agents or alkylating agents) in a standard chemotherapy re ...

drugs for breast cancer.

Technology

DirectHit is based on quantitative

immunofluorescence Immunofluorescence (IF) is a light microscopy-based technique that allows detection and localization of a wide variety of target biomolecules within a cell or tissue at a quantitative level. The technique utilizes the binding specificity of anti ...

technology Technology is the application of Conceptual model, conceptual knowledge to achieve practical goals, especially in a reproducible way. The word ''technology'' can also mean the products resulting from such efforts, including both tangible too ...

. According to recent studies, quantitative immunofluorescence (QIF) can be applied to the standardization of

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residue (biochemistry), residues. Proteins perform a vast array of functions within organisms, including Enzyme catalysis, catalysing metab ...

analysis, resulting in increased sensitivity and reproducibility. It is important to be able to quantitate the expression of predictive factors in breast cancer, because response to therapy is often dependent upon the concentration of particular proteins within the tissue. DirectHit utilizes

monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a Lineage (evolution), cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Mon ...

(mAb) corresponding to each

biomarker In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, ...

to stain the tumor tissue samples. Slides are evaluated with a computerized,

fluorescence Fluorescence is one of two kinds of photoluminescence, the emission of light by a substance that has absorbed light or other electromagnetic radiation. When exposed to ultraviolet radiation, many substances will glow (fluoresce) with colore ...

microscopy Microscopy is the technical field of using microscopes to view subjects too small to be seen with the naked eye (objects that are not within the resolution range of the normal eye). There are three well-known branches of microscopy: optical mic ...

system . Digital images are acquired through a CCCD camera. An algorithm was developed to process and analyze the digital images allowing direct relation between the amount of a specific protein within the

cancer cell Cancer cells are cells that divide continually, forming solid tumors or flooding the blood or lymph with abnormal cells. Cell division is a normal process used by the body for growth and repair. A parent cell divides to form two daughter cells, an ...

s of the tumor and response to the corresponding drug. Quantitative measurement of up to five signals in a single

cell Cell most often refers to: * Cell (biology), the functional basic unit of life * Cellphone, a phone connected to a cellular network * Clandestine cell, a penetration-resistant form of a secret or outlawed organization * Electrochemical cell, a de ...

can be obtained.

Clinical Trials

The DirectHit Panel for Breast Cancer was validated in retrospective clinical trials conducted at The

University of Maryland The University of Maryland, College Park (University of Maryland, UMD, or simply Maryland) is a public land-grant research university in College Park, Maryland, United States. Founded in 1856, UMD is the flagship institution of the Univ ...

Greenebaum Cancer Center and Harborview Cancer Center in

Baltimore Baltimore is the most populous city in the U.S. state of Maryland. With a population of 585,708 at the 2020 census and estimated at 568,271 in 2024, it is the 30th-most populous U.S. city. The Baltimore metropolitan area is the 20th-large ...

, MD. One key biomarker was selected as a correspondent to each drug, These biomarkers were identified as playing a significant role in

cancer Cancer is a group of diseases involving Cell growth#Disorders, abnormal cell growth with the potential to Invasion (cancer), invade or Metastasis, spread to other parts of the body. These contrast with benign tumors, which do not spread. Po ...

processes and as bearing a mechanistic relation to the action of the specified drug. The drug groups used as treatment and their related biomarkers are as follows: Trastuzumab/HER-2/neu, Antiestrogens/Estrogen Receptor, Taxanes/beta-tubulin III, 5FU/Thymidylate Synthase. In these trials DirectHit analysis of

estrogen Estrogen (also spelled oestrogen in British English; see spelling differences) is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three ...

receptor and HER-2/neu displayed a higher predictive accuracy for treatment outcomes with anti estrogen drugs and Trastuzumab than standard methods. In addition DirectHit displayed exceptional predictive accuracy for chemotherapy response (88%). DirectHit also displayed an extreme specificity for predictions of drug resistance (100%).

Cost

The cost of the DirectHit Panel for Breast Cancer is $3500. The use of DirectHit could result in significant cost savings because physicians will be able to customize treatment regimens for patients, eliminating ineffective drugs that would have otherwise been prescribed If a 50% treatment failure rate is assumed for standard chemotherapy, then the use of the DirectHit Test Panel for Breast Cancer could result in potential savings of approximately $466M in drug costs alone for 40,000 late stage cancer patients in the United States. If ancillary costs are also considered, DirectHit testing could result in a total savings of $566M - $666M.

References

External links

Cancer.org

CCC Diagnostics Homepage

Directhittest.com
{{DEFAULTSORT:Directhit Medical diagnosis

Technology

Clinical Trials

Cost

See also

References

Further reading

External links