Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1999-01-20
2001-03-06
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007100, C435S007230, C435S007900, C435S007940, C435S188000, C530S350000, C530S388250, C530S388850, C530S391300
Reexamination Certificate
active
06197532
ABSTRACT:
This invention pertains to the diagnosis and detection of breast cancer and other cancers.
Breast cancer is the second most common cause of cancer-related death after lung cancer, and remains the leading cause of cancer-related death in women between the ages of 40 and 55. Early detection and diagnosis is associated with significantly improved long-term survival. It is therefore of critical importance to identify screening markers that can accurately and reliably detect breast cancer.
Riboflavin, one of the B vitamins, is essential for cell growth and development. The transport and subsequent deposition of riboflavin in developing cells is facilitated by an estrogen-induced phosphoglycoprotein called riboflavin carrier protein (RCP). RCP binds riboflavin in a 1:1 molar ratio.
In pregnancy studies in rodents and primates, immunological interference with RCP to inhibit riboflavin transport to the developing embryo has been reported to cause acute fetal wastage and miscarriage. See R. Adiga et al., “Carrier protein mediated transplacental riboflavin transport in the primate,” pp. 129-140 in N. Moudgal et al. (eds.),
Perspectives in Primate Reproductive Biology
(1991).
P. Ramesh Babu et al., “Evidence for estrogen-induced riboflavin carrier protein in sera of human breast cancer: its correlation with estrogen receptor status,”
Med. Sci. Res
., vol. 24, pp. 37-39 (1996) studied the presence of riboflavin carrier protein in human breast cancer patients and stated, “In conclusion, our studies show that despite the correlation of circulatory RCP with the ER [estrogen receptor] status of breast cancer patients, its presence in low quantities in the circulation of the majority of patients failed to confirm its value as a potential marker in the management of human breast cancer.”
Surprisingly, we have discovered a reliable, sensitive, and specific method to detect breast cancer and other cancers in humans and other mammals by specific measurements of elevated levels of riboflavin carrier protein in serum or other biological fluids. We have also prepared stains specific for riboflavin carrier protein that have been used to visualize malignancies in tissue specimens. The new technique is particularly well-suited for the early detection of breast cancer.
Using a highly sensitive radioimmunoassay, we have observed that serum RCP levels were significantly elevated in women with breast cancer (n=46) as compared to control subjects (n=19) (6.20±7.8 ng/ml versus 0.76±0.27 ng/ml, p<0.05). A serum RCP level ≧1.0 ng/ml was highly predictive of the presence of breast cancer, accurately detecting 89.2% of tumors in stages I and II and 100% of tumors in stages III and IV. Overall this RCP-based test had a sensitivity of 91%, a specificity of 74%, and a positive predictive value of 89%.
REFERENCES:
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patent: 5798257 (1998-08-01), Zain et al.
Adiga, P. et al., “Biochemical and immunological aspects of riboflavin carrier protein,”J. Biosci., vol. 13, pp. 87-104 (1988).
Adiga, R. et al., “Carrier protein mediated transplacental riboflavin transport in the primate,” pp. 129-140 in N. Moudgal et al. (eds.),Perspectives in Primate Reproductive Biology(1991).
Natraj, U. et al., “Isolation and partial characterisation of human riboflavin carrier protein and the estimation of its levels during human pregnancy,”J. Reprod. Immunol., vol. 13, pp. 1-16 (1988).
Ramesh Babu, P. et al., “Evidence for estrogen-induced riboflavin carrier protein in sera of human breast cancer: its correlation with estrogen receptor status,”Med. Sci. Res., vol. 24, pp. 37-39 (1996).
Raj Madhwa H. G.
Rao Prakash N.
Board of Supervisors of Louisiana State University and Agricultu
Helms Larry R.
Huff Sheela
Runnels John H.
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